[Federal Register Volume 76, Number 117 (Friday, June 17, 2011)]
[Rules and Regulations]
[Pages 35620-35665]
[FR Doc No: 2011-14766]

Vol. 76

Friday,

No. 117

June 17, 2011

Part IV

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Parts 201, 310, and 352

Sunscreen Drug Products for Over-the-Counter Human Use; Final Rules and
Proposed Rules

Federal Register / Vol. 76 , No. 117 / Friday, June 17, 2011 / Rules
and Regulations

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 310

[Docket No. FDA-1978-N-0018] (Formerly Docket No. 1978N-0038)
RIN 0910-AF43

Labeling and Effectiveness Testing; Sunscreen Drug Products for
Over-the-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this
document to address labeling and effectiveness testing for certain
over-the counter (OTC) sunscreen products containing specified active
ingredients and marketed without approved applications. This document
addresses labeling and effectiveness testing issues raised by the
nearly 2,900 submissions that we received in response to the sunscreen
proposed rule of August 27, 2007 (2007 proposed rule). The document
also identifies specific claims that render a product that is subject
to this rule misbranded or would not be allowed on any OTC sunscreen
product marketed without an approved application. The document does not
address issues related to sunscreen active ingredients or certain other
issues regarding the GRASE determination for sunscreen products. The
document requires OTC sunscreen products to comply with the content and
format requirements for OTC drug labeling contained in the 1999 Drug
Facts final rule (published in the Federal Register of March 17, 1999,
by lifting the delay of implementation date for that rule that we
published on September 3, 2004).

DATES: Effective Date: This final rule is effective June 18, 2012. For
additional information concerning this effective date, see section X in
the preamble of this document. The incorporation by reference of a
certain publication listed in this rule is approved by the Director of
the Federal Register as of June 18, 2012.
    Compliance Date: The compliance date for all products subject to
this final rule with annual sales less than $25,000 is June 17, 2013.
The compliance date for all other products subject to this final rule
is June 18, 2012.
    Implementation date: FDA is lifting the delay of implementation
date for Sec.  201.66 as published at 69 FR 53801, September 3, 2004.

FOR FURTHER INFORMATION CONTACT: Reynold Tan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993, 301-796-
2090.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Overview of Document
    A. Rulemaking History
    B. Scope of This Document
    C. Issues Outside the Scope of This Document
    D. Enforcement Policy
    E. Summary of Major Revisions to the Labeling and Testing
Requirements Included in the 2007 Proposed Rule
II. Administrative and Other Issues
III. Principal Display Panel (PDP) Labeling
    A. SPF Statement
    B. Broad Spectrum Statement
    C. Water Resistance Statement
    D. UVB and UVA Educational Statement
IV. Drug Facts Labeling
    A. Active Ingredients/Purpose
    B. Uses
    C. Warnings
    D. Directions
    E. Constitutionality of Labeling Statements Regarding Skin
Cancer and Skin Aging
    F. Other Information
    G. Reduced Labeling
V. Miscellaneous Labeling Outside Drug Facts
VI. SPF Test Parameters
    A. Solar Simulator
    B. Sunscreen Standards
    C. Test Subjects
    D. Test Sites and Subsites
    E. Finger Cot
    F. Application Amount
    G. Water Resistance
VII. SPF Test Issues (Other Than Test Parameters)
    A. Pass/Fail (Binomial) SPF Test
    B. Photostability
    C. In Vitro SPF Test
    D. Anti-Inflammatory Ingredients
VIII. Broad Spectrum Test
    A. In Vivo Test Method: Not Required
    B. In Vitro Test Method: Critical Wavelength
    C. Critical Wavelength Test Parameters
IX. Analysis of Impacts
    A. Final Regulatory Impact Analysis
    B. Small Business Impact (Final Regulatory Flexibility Analysis)
X. Paperwork Reduction Act of 1995
XI. Environmental Impact
XII. Federalism
XIII. References

I. Overview of Document

A. Rulemaking History

    This section of the document does not discuss every regulatory
action associated with OTC sunscreen products. It highlights the major
regulatory actions that are related to the regulatory actions being
taken in this document. For a complete list of all regulatory actions
associated with OTC sunscreen products, please refer to our Web site:
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Over-the-CounterOTCDrugs/StatusofOTCRulemakings/ucm072134.htm.
    In the Federal Register of May 12, 1993 (58 FR 28194), we published
a proposed rule for OTC sunscreen products that identified active
ingredients we tentatively considered to be generally recognized as
safe and effective (GRASE), as well as associated labeling and sun
protection factor (SPF) testing to be required for these OTC sunscreen
products (the 1993 proposed rule). The SPF test and corresponding
labeling reflect the level of protection against sunburn, which is
caused primarily by UVB radiation. The 1993 proposed rule also
explained the importance of protection against UVA radiation (58 FR
28194 at 28232 and 28233). The proposed rule referenced published UVA
test methods but did not propose a specific method (58 FR 28194 at
28248 to 28250). Rather, the proposed rule stated that a sunscreen
product could be labeled as ``broad spectrum,'' or labeled with a
similar statement, if it protected against UVA radiation as
demonstrated by one of the published UVA tests or a similar test.
    In April 1994, we reopened the administrative record to allow
additional submissions concerning UVA-related issues. We also announced
a public meeting to be held in May 1994 to discuss UVA testing
procedures (59 FR 16042, April 5, 1994). We held the public meeting to
gather more information to help us determine the most appropriate UVA
test method and labeling.
    In November 1997, Congress enacted the Food and Drug Administration
Modernization Act of 1997 (FDAMA), which addressed OTC sunscreen
products among other FDA issues. Section 129 of FDAMA stated that ``not
later than 18 months after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue regulations for
over-the-counter sunscreen products for the prevention or treatment of
sunburn.'' We then determined that the GRASE active ingredients, SPF
testing requirements, and related labeling were issues that we could
finalize within the timeframe set by FDAMA. Because we had not
previously proposed specific UVA testing and labeling requirements, we
did not have sufficient time to finalize these UVA requirements within
the FDAMA timeframe.
    In the Federal Register of May 21, 1999, we published a final rule
for OTC

sunscreen products (64 FR 27666). The 1999 sunscreen final rule added
the sunscreen monograph (regulations) in part 352 (21 CFR part 352) and
included an effective date of May 2001. The 1999 sunscreen final rule
stated that we would publish a proposed rule outlining UVA testing and
labeling requirements at a future date. In 2000, we extended the
effective date for the 1999 sunscreen final rule to December 2002 (65
FR 36319, June 8, 2000).
    In December 2001, we stayed the December 2002 effective date of the
1999 sunscreen final rule indefinitely. We took this action because we
planned to revise part 352 to add UVA testing and labeling requirements
so that OTC sunscreen products would be tested and labeled for both UVB
and UVA radiation protection. We included these revisions in a proposed
rule that published in the Federal Register of August 27, 2007 (72 FR
49070). The 2007 proposed rule identified UVA testing and labeling that
we proposed should be required for all OTC sunscreen products. The
proposed rule also revised SPF testing and corresponding labeling from
the 1999 final rule. The proposed rule did not lift the existing stay
of the effective date for part 352.
    On September 3, 2004 (69 FR 53801), we delayed until further notice
the implementation date for the Drug Facts final rule (64 FR 13254,
March 17, 1999) (21 CFR 201.66) for OTC sunscreen products. The Drug
Facts final rule (21 CFR 201.66) establishes general labeling format
and content requirements for all OTC drugs. We explained that we
postponed the implementation date for general Drug Facts labeling
requirements for sunscreens because we did not expect to issue the
sunscreen final rule containing UVA testing and product-specific
labeling requirements (i.e., this document) by the Drug Facts
implementation date of May 2005. Therefore, we delayed the
implementation date until further notice to prevent sunscreen product
manufacturers from having to relabel their products at two closely
related time intervals, as initially required by the 1999 Drug Facts
final rule and the 1999 sunscreen final rule.

B. Scope of This Document

    This final rule establishes the labeling and testing requirements
for OTC sunscreen products containing specific ingredients or
combinations of ingredients and marketed without an approved
application under section 505 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355) (the FD&C Act). The requirements in this final rule
will help ensure that these currently marketed sunscreen products are
appropriately labeled and tested for both UVA and UVB protection. In
addition, the requirements in this final rule will help ensure the
proper use of these sunscreens and greater consumer protection from the
damaging effects of UV radiation. This final rule also identifies
claims that render a product that is subject to this rule misbranded or
are not allowed on any OTC sunscreen drug product marketed without an
approved application.
    As described in the previous section of this document, we issued
the 2007 proposed rule as a proposed amendment to the sunscreen
monograph requirements in 21 CFR part 352 primarily to establish UVA
testing and labeling requirements so that all OTC sunscreen products
marketed under the sunscreen monograph would be tested and labeled for
both UVB and UVA radiation protection. Sunscreen active ingredients,
UVB testing, UVB labeling, and other conditions under which sunscreens
would be considered GRASE and not misbranded had been addressed in the
1999 (stayed) final rule. In response to the 2007 proposed rule,
however, we received submissions from the public concerning all aspects
of the sunscreen monograph (i.e., the conditions specified in the 1999
final rule and the 2007 proposed rule). As discussed further in this
section, some of the issues regarding the monograph conditions raised
in the public submissions will require further evaluation by us.
Therefore, we are not issuing a final monograph with GRASE conditions
for sunscreens in this document. Instead, we are publishing this final
rule establishing labeling and the effectiveness testing upon which it
relies, which applies to the same sunscreens that were the subject of
the 2007 proposed rule to amend the monograph, because it is in the
best interest of public health to publish this final rule while we work
on remaining issues that need to be addressed in order to publish a
final monograph. This labeling will help ensure that these products are
not misbranded by providing specific indications, directions, warnings,
and other important information to help consumers select and use them
appropriately.
    In this final rule, then, we are codifying in 21 CFR part 201
requirements for OTC sunscreen products containing specified active
ingredients and marketed without approved applications under section
505 of the FD&C Act (21 U.S.C. 355) (hereafter referred to as
``covered'' products). With respect to these covered products, this new
section 21 CFR 201.327 includes requirements for labeling and the
effectiveness testing upon which it relies. Because we have not yet
resolved all of the issues regarding conditions under which sunscreens
are GRASE and not misbranded, the stay of 21 CFR part 352 remains in
effect. Although we are not yet codifying these labeling and related
effectiveness testing provisions in the monograph regulation, they do
embody the agency's current determination on appropriate regulation of
these aspects of sunscreens that were previously identified as falling
within the monograph in part 352, and supersede the prior approach
embodied in the never-effective provisions of 21 CFR part 352 subparts
C and D. While this rule does not lift the stay of part 352, we are
lifting the delay of implementation date for the Drug Facts labeling
requirements of 21 CFR 201.66. In addition, this rule codifies certain
specific claims that render a covered product misbranded or are not
allowed on any OTC sunscreen drug product marketed in the United States
without an approved application.
    We note that all provisions of new 21 CFR 201.327 and the
amendments to 310.545 included in this rule apply only to the
aforementioned covered products, and references in this document to
``covered'' products recognize this limitation. Manufacturers of
sunscreen products that are already being marketed pursuant to an
approved application can contact FDA's Center for Drug Evaluation and
Research to discuss supplemental submissions that would enable them to
include labeling on their products like that specified in this final
rule.

C. Issues Outside the Scope of This Document

    There are a number of issues that were raised in public submissions
responding to the 2007 proposed rule that are outside the scope of this
document. The issues fall into two categories:
     GRASE determination for sunscreen products and active
ingredients
     Issues affecting multiple OTC drug monographs

As explained below, in this document, we are not addressing these
issues related to determining the GRASE status of sunscreen products or
sunscreen active ingredients and are not addressing the issues
described below affecting multiple OTC drug monographs.

1. Issues Regarding GRASE Determination for Sunscreen Products and
Active Ingredients
    A large number of submissions on the 2007 proposed rule raised
issues related to the conditions that define what constitutes a GRASE
finished OTC sunscreen product, irrespective of its active ingredients.
These included over 1000 submissions requesting that we limit the
monograph to sunscreens that offer broad spectrum protection and have
SPF values of 15 or higher. Because this final rule is a labeling rule,
and not a monograph, we do not address these issues here but plan to
address them in future rulemakings regarding the monograph and
conditions for general recognition of safety and effectiveness.
    This rule also does not address issues related to the GRASE status
of sunscreen active ingredients that are included in the 2007 proposed
rule (proposed 21 CFR 352.10 and 352.20). We received 20 submissions
raising questions about the safety of ingredients in sunscreens (Ref.
1). Ten of the submissions specifically asked that we ensure that none
of the ingredients are carcinogenic. Others asked that we ensure that
all ingredients in sunscreens are safe without citing a specific
concern. We intend to address carcinogenicity and other safety
considerations related to sunscreen active ingredients in a future
rulemaking.
    We also received submissions requesting that we increase the GRASE
concentration of avobenzone from 3 percent to 5 percent (Ref. 1).
Another submission points out that there are two USP \1\ monographs for
zinc oxide:
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    \1\ United States Pharmacopeia.
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     Zinc oxide (Ref. 2)
     Zinc oxide neutral (Ref. 3)

The submission would like us to clarify that zinc oxide in OTC
sunscreen products can meet the specifications of either USP monograph
(Ref. 1). We intend to address all of these issues regarding GRASE
determination for sunscreen active ingredients in future rulemakings.
    In addition, we received two submissions requesting that we
classify three new ingredients not previously marketed in the United
States as GRASE: bemotrizinol, bisoctrizole, and octyl triazone (Ref.
1). We found these active ingredients eligible for review under the OTC
drug monograph system in 2003 (octyl triazone) and 2005 (bemotrizinol
and bisoctrizole) (68 FR 41386, July 11, 2003, and 70 FR 72449,
December 5, 2005). We are currently reviewing the safety and
effectiveness data submitted for these and other sunscreen active
ingredients found eligible for potential addition to the monograph.
When we complete our review, we will issue proposed rules stating our
tentative conclusions on the safety and effectiveness of all of these
ingredients.
2. Issues Affecting Multiple OTC Drug Monographs
    This final rule also does not address three issues raised in
response to the 2007 sunscreen proposed rule that are not specific to
sunscreen products. Because these issues apply more generally to
multiple categories of OTC drug products, we are not addressing these
issues in this final rule, which is limited to OTC sunscreen products.
    The first issue concerns the inclusion of expiration dates on
sunscreen labels. We received 12 submissions requesting that we require
OTC sunscreen products to be labeled with an expiration date (Ref. 1).
Currently, regulations in 21 CFR 211.137(h) do not require that an
expiration date be included in labeling if an OTC drug product does not
have any dosage limitations and is stable for at least 3 years. This
regulation applies to many OTC drug products, including sunscreen
products. Any modification of the existing regulations would require
publication of a proposed rule addressing all OTC drug products
affected by the expiration date regulations.
    The second issue concerns the term ``final monograph.'' One
submission argued that we should not use this term because it is
inaccurate (Ref. 1). As the submission states, ``FDA is to continually
evaluate products, so nothing is ever finalized.'' This issue applies
to monographs representing all categories of OTC drug products.
Therefore, we are not addressing the issue in this document.
    The third issue concerns the country of origin listing for all
ingredients (i.e., both active and inactive ingredients) on a sunscreen
drug product. We received a submission requesting that we provide the
country of origin for each ingredient. The submission also requested
that manufacturers be required to provide specific details about what
each ingredient does in the product. This issue applies to all OTC drug
products and, therefore, we are not addressing it in this document.

D. Enforcement Policy

    As noted, no final monograph is currently in effect for OTC
sunscreen drug products, and in its absence, questions may arise
regarding FDA's enforcement policy for OTC sunscreen products marketed
without approved applications. To clarify expectations for industry,
elsewhere in this issue of the Federal Register, we are announcing the
availability of a draft guidance document, explaining the agency's
intended enforcement policy for these products until a final sunscreen
monograph becomes effective.

E. Summary of Major Revisions to the Labeling and Effectiveness Testing
Included in the 2007 Proposed Rule

    In response to the 2007 proposed rule, we received almost 2,900
submissions from the public. Of these submissions, over 2,500 expressed
general support for the proposed rule and urged us to finalize and
implement the new rule quickly. Three hundred twenty-five of the
submissions raised approximately 90 specific issues related to the
proposed rule. We have addressed the issues specifically relating to
labeling and effectiveness testing in this final rule. Based on the
submissions received, and the information and data included in those
submissions or otherwise available to us, we have re-evaluated our
position on several issues in the 2007 proposed rule and made several
changes to our proposed labeling and testing requirements. Tables 1, 2,
4, and 5 in this document summarize the labeling and effectiveness
testing requirements included in the 2007 proposed rule as well as the
labeling and effectiveness testing required by this final rule:
     Table 1: PDP Labeling (discussed in section III)
     Table 2: Drug Facts Labeling (discussed in section IV)
     Table 4: SPF Test (discussed in section VI)
     Table 5: Broad Spectrum Test (discussed in section VIII)

Rather than summarizing all of the revisions to the labeling and
testing included in the 2007 proposed rule, we are highlighting what we
consider to be the most important revisions in this section of the
document.

    We made the following changes to the proposed labeling:
    1. The proposed UVA ``star rating'' is not required on the PDP.
    2. A combined ``Broad Spectrum SPF'' statement is required on the
PDP for sunscreen products that pass the broad spectrum test
established in new 21 CFR 201.327(j). To pass the broad spectrum test,
the amount of UVA protection must increase as the SPF value increases.
    3. For sunscreen products that pass the broad spectrum test
established in new 21 CFR 201.327(j) and have SPF

values of 15 or higher in accordance with the SPF test in 21 CFR
201.327(i):
    a. The ``Sun Alert'' warning proposed as the first warning in 2007
is not required (Warning proposed located in 21 CFR 352.52(c)(1)).
    b. A new indication statement may be included to inform consumers
that using the product ``as directed with other sun protection measures
(see Directions [in bold italic font]) decreases the risk of skin
cancer and early skin aging caused by the sun.''
    c. A new direction statement has been added informing consumers
that exposure to the sun increases the risk of skin cancer and early
skin aging and providing a list of specific sun protection measures
that can decrease this risk.
    4. For any OTC sunscreen product that does not pass the broad
spectrum test in 21 CFR 201.327(j), or that are broad spectrum with an
SPF value less than 15, this final rule, like the 2007 proposed rule,
requires that the first warning indicate the adverse consequences of
spending time in the sun. The wording of this warning has been revised
to state, ``Skin Cancer/Skin Aging Alert [in bold font]: Spending time
in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to help prevent sunburn, not [in bold
font] skin cancer or early skin aging.''
    We also made the following changes to the effectiveness testing
proposed in 2007:
    1. The number of subjects required in the SPF test has been reduced
from 20 subjects to 10 subjects.
    2. One in vitro test is required to demonstrate broad spectrum
protection rather than the two previously proposed tests (an in vitro
test and an in vivo test).
    3. The broad spectrum test is a pass/fail test based on the
critical wavelength value of 370 nm \2\.
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    \2\ Nanometers.
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II. Administrative and Other Issues

    Some of the submissions that we received following publication of
the 2007 proposed rule made the following requests involving
administrative issues (Ref. 1):
     Extend the comment period of the 2007 proposed rule.
     Lift the stay on 21 CFR part 352, imposed in 2001 (66 FR
67485).
     Allow interim marketing of products containing avobenzone
with ensulizole and avobenzone with zinc oxide.
     Set an effective date for this final rule other than the
18 months proposed in the 2007 proposed rule.
     Revise the preemption language included in the 2007
proposed rule by deleting any references regarding the rule's potential
preemption of State tort law.

Our positions on these issues are discussed in the remainder of this
section of the document.
    All of the requests to extend the comment period were submitted
before the November 28, 2007 Federal Register notice in which we
extended the comment period of the 2007 proposed rule (72 FR 67264). In
that notice, we extended the close of the comment period from November
26, 2007, to December 26, 2007. We have not received any more requests
to extend the comment period since December 2007.
    With regard to requests to lift the stay of 21 CFR part 352 (the
OTC sunscreen monograph), as already discussed, our 2007 proposed rule
anticipated amending the testing and labeling provisions of that
monograph and subsequently lifting the stay. However, comments received
on the 2007 proposed rule not only addressed labeling and effectiveness
testing for final sunscreen formulations, but also raised other issues
about the monograph conditions for OTC sunscreen products that require
further consideration. As a result, we are not finalizing amendments to
part 352 at this time nor lifting the stay placed on that section as
enacted in 1999 (66 FR 67485). Rather, this final rule establishes in
21 CFR 201.327 labeling requirements and the effectiveness testing upon
which it relies for covered OTC sunscreen drug products. We intend to
lift the stay on part 352 when we reach our final conclusions on the
conditions under which sunscreen products are GRASE and not misbranded,
including a determination regarding sunscreen active ingredients, and
publish a revised final monograph. In the interim, the labeling and
effectiveness testing provisions of this rule apply to covered OTC
sunscreen products.
    We received a request that we allow interim marketing of avobenzone
combinations in proposed Sec.  352.20(a)(2) prior to issuing a final
rule for part 352. Subject to our enforcement discretion, we will
continue to allow the marketing of avobenzone combinations provided for
in the 1999 sunscreen final rule. However, we are not allowing
marketing of the additional avobenzone combinations discussed in the
2007 proposed rule until we reach a final conclusion on the GRASE
determination for sunscreen active ingredients and combinations of
those ingredients.
    We are requiring that this final rule become effective in 1 year,
even though we considered 18 months in the 2007 proposed rule (72 FR
49070 at 49110). We are allowing products with annual sales less than
$25,000 to comply with this rule in 2 years, as stated in the 2007
proposed rule. In response to the proposed rule, we received one
submission arguing that we should require this final rule to become
effective in 1 year (Ref. 1). The submission stated that a later
effective date would have a negative public health impact. We received
eight submissions arguing that we should extend the effective date from
the proposed 18 months to 3 years (Ref. 1). The submissions listed the
following reasons for allowing more than 18 months:
     Repackaging
     Relabeling
     Testing/retesting
     Removing products from market
     Impact on small businesses

The most common argument was that more time would be needed to test/
retest OTC sunscreen products for broad spectrum protection in
accordance with both the in vitro and in vivo UVA test methods included
in the proposed rule.

    We agree with the submission which stated that it would be
beneficial for consumers to have this rule become effective within 1
year. As explained in section VIII.A of this document, we are not
requiring manufacturers to demonstrate broad spectrum protection by
conducting in vivo and in vitro tests. This final rule requires that
manufacturers conduct only the simpler and less expensive nonclinical
in vitro test to demonstrate broad spectrum protection. In vitro tests
are substantially shorter than in vivo tests. Therefore, we are setting
an effective date for this rule 1 year from the date of publication in
the Federal Register. However, we are providing two years for all
products with annual sales less than $25,000 to comply with this rule.
In addition, in order to ensure that limited testing laboratory
capacity does not result in sunscreen shortages during the transition
to the new rule, we intend to exercise enforcement discretion for a
period of time with regard to the SPF test for certain OTC sunscreen
products on the market by June 17, 2011 (see our draft guidance
entitled ``Guidance for Industry: Enforcement Policy--OTC Sunscreen
Drug Products Marketed Without An Approved Application'' announced
elsewhere in this issue of the Federal Register).
    The submissions stating that additional time is necessary for

repackaging and relabeling did not submit any information or data to
support these arguments (Ref. 1). The argument that more than 18 months
is needed to remove non-compliant products from the market is not
valid. In the 2007 proposed rule, we indicated that sunscreen products
which are already distributed by the effective date of the final rule
would not be expected to be relabeled or retested in conformity with
the final rule conditions unless these products were subsequently
relabeled or repackaged after the effective date (72 FR 49070 at
49109). Consistent with this statement, we do not expect non-compliant
products introduced or delivered for introduction into interstate
commerce prior to the compliance dates specified for this final rule to
be removed from the market.
    We received a submission that expressed concern about the agency's
preemption discussion in the 2007 proposed rule (72 FR 49070 at 49109
and 49110) and requested that we delete any discussion regarding the
rule's potential preemption of State tort law (Ref. 1). The submission
claimed that we exceeded our authority when we stated that section
751(a) of the FD&C Act displaces both State legislative requirements
and State common law duties. The submission argued that Congress
intended to preserve State common law claims by including section
51(e), which exempts State product liability claims from express
preemption under section 751(a) of the FD&C Act. The commenter appears
to have construed our statement in a way that would nullify section
751(e) of the FD&C Act. We did not intend to suggest that section
751(a) of the FD&C Act preempts State product liability claims, whether
based on State legislative enactments or common law, because section
751(e) exempts such actions from the express preemption provision in
section 751(a). However, it is important to note that section 751(e) of
the FD&C Act exempts only those common law claims that are based on
State product liability law. Our revised preemption discussion in
section XII remains consistent with applicable law.
    The submission also requested that we delete any references to
implied preemption. In this final rule, we have omitted any statement
regarding implied preemption because, although implied preemption may
arise, such scenarios are necessarily case-specific. Section XII of
this document makes clear that the sole statutory provision giving
preemptive effect to the final rule is section 751 of the FD&C Act.

III. Principal Display Panel (PDP) Labeling

    In response to the 2007 sunscreen proposed rule, we received 45
submissions requesting that we revise the proposed principal display
panel (PDP) labeling (Ref. 1). We are revising the PDP labeling based,
in part, on these submissions (see table 1 of this document). We have
decided that the PDP labeling included in this document will simplify
the purchase decision for consumers by allowing them to more easily
find important information included on the PDP.

  Table 1--Summary of PDP Labeling in the 2007 Proposed Rule and This Final Rule Using a Broad Spectrum SPF 30
 Water Resistant Sunscreen Product as Example A and an SPF 6 Sunscreen That Is Not Broad Spectrum and Not Water
                                             Resistant as Example B
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         Labeled information                       2007 Proposed rule                     This final rule
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Effectiveness Rating \1\.............  Example A:                                  Example A:
                                       ``UVB SPF 30 High''                         ``Broad Spectrum SPF 30''
                                       ``UVA [starf][starf][starf][star14] High''
                                       Example B:                                  Example B:
                                       ``UVB SPF 6 Low''                           ``SPF 6''
                                       ``No UVA Protection''
Water Resistance.....................  Example A:                                  Example A:
                                       ``Water Resistant''                         ``Water Resistant (40
                                                                                minutes)''
                                       Example B:                                  Example B:
                                       No statement on water resistance            No statement on water
                                                                                resistance
Educational Statement................  Examples A & B:                             Examples A & B:
                                       ``UV rays from the sun are made of UVB and  No educational statement
                                        UVA. It is important to protect against
                                        both UVA and UVB rays.''
----------------------------------------------------------------------------------------------------------------
\1\ The UVA rating in the 2007 proposed rule is a four-tier rating (low, medium, high, highest). The UVA testing
  in this final rule is pass/fail--a product is either allowed or not allowed to include a broad spectrum
  statement depending on results of the test described in new 21 CFR 201.327(j) (see section VIII of this
  document).

A. SPF Statement

    In the 2007 sunscreen proposed rule, we proposed redefining the
acronym ``SPF'' as the ``sunburn protection factor.'' We also proposed
that the term ``UVB SPF'' would be required on the PDP of all OTC
sunscreen products (proposed 21 CFR 352.50(a)). This term would be
followed by the numerical value determined from SPF testing and one of
the following descriptors: ``low,'' ``medium,'' ``high,'' or
``highest.'' For example, a sunscreen product could have contained the
statement ``UVB SPF 40 High'' on the PDP.
    We received 12 submissions regarding the SPF statement in response
to the 2007 sunscreen proposed rule (Ref. 1). Collectively, the
submissions made the following requests:
    1. Do not change the definition of SPF to ``sunburn protection
factor''
    2. Remove UVB from ``UVB SPF''
    3. Redefine the ``highest'' product category descriptor to include
SPF 50
    4. Require SPF values expressed in multiples of 5
    5. Label SPF as the percent of UVB radiation screened

As discussed in the remainder of this section, we agree with the first
and second requests, but are not granting the other three requests.

    In this final rule, unlike the 2007 proposed rule, we have no
express definitional section. However, we identify ``SPF'' as an
abbreviation for ``sun protection factor'' in new 21 CFR 201.327(a)(1),
and use it consistently in this way throughout the rule. This use of
the term SPF is identical to the definition in the 1999 stayed
sunscreen final rule (64 FR 27666). For products that are not broad
spectrum, the term ``SPF'' will appear on the PDP with the numerical
SPF value calculated according to the test method in new 21

CFR 201.327(i). For broad spectrum sunscreen products, the term ``Broad
Spectrum SPF'' will appear on the PDP along with the numerical SPF
value calculated according to the test method in new 21 CFR 201.327(i).
    The term ``UVB'' will not be required as part of the SPF statement.
We are also not requiring the descriptor (e.g., ``high'' or ``low'').
We included these two requirements in the 2007 proposed rule because we
had concluded that the requirements would help consumers understand the
side-by-side SPF numerical rating in conjunction with the UVA star
rating, which included the term ``UVA'' and the same descriptors (72 FR
49070 at 49084). As discussed in section III.B of this document, the
UVA star rating is not being included in this final rule, and as
discussed below, we have concluded that neither the term ``UVB'' nor
the descriptor is necessary for consumers to understand the
effectiveness statement.
    Neither the term ``UVB'' nor a descriptor (e.g. ``low'' or
``high'') had been included on sunscreen labels prior to our 2007
proposal, and consumers had been able to make purchase and use
decisions based on SPF values alone. Under this final rule, the SPF
value will be expressed on the PDP by including the term ``SPF,''
followed by the numerical value determined from the SPF test, similar
to how it has appeared on the labels of OTC sunscreen products for more
than 30 years. As described in section III.B of this document, for
products passing the critical wavelength test in new 21 CFR 201.327(j),
the SPF value statement will be expressed as ``Broad Spectrum SPF''
followed by the numerical SPF value calculated according to the test
method in 21 CFR 201.327(i).
    We received five submissions objecting to the definition of SPF as
``sunburn protection factor'' and only one submission supporting the
definition (Ref. 1). The submissions objecting to the definition argued
that, if the term ``sunburn protection factor'' is used, consumers may
mistakenly assume that a higher SPF value means a higher probability of
sunburn. Additionally, they argued that sunscreen products protect
against various harmful effects of sun exposure, such as early skin
aging and skin cancer, in addition to protecting against sunburn. Some
submissions suggested that the term ``sunburn protection factor'' will
lead consumers with darker skin to assume that they do not need
sunscreen products because they do not burn easily (Ref. 1).
    We agree with the arguments provided by the submissions suggesting
that the term ``sunburn protection factor'' may be misleading. In the
2007 sunscreen proposed rule, we revised the definition of SPF from
``sun protection factor'' to ``sunburn protection factor'' because we
thought that the new definition was more descriptive of what an SPF
value represents (72 FR 49070 at 49077). The SPF value is determined
from a clinical test with sunburn as the endpoint. However, for broad
spectrum sunscreen products, the SPF statement also serves as a
relative measure of the magnitude of broad spectrum protection (Ref.
4). In this final rule, while we do not codify a separate definitional
section, we continue to use the term ``SPF'' to mean ``sun protection
factor,'' as we had done in the 1999 final rule (21 CFR 201.327(a)(1)).
    In this final rule, we are also revising the effectiveness
statement so that the term ``UVB'' is not required before the term
``SPF,'' as proposed in the 2007 proposed rule (proposed 21 CFR
352.50(a)). We received six submissions requesting this revision (Ref.
1). These submissions argued that ``UVB SPF'' is an incorrect
representation of the SPF value determined from a test using a solar
stimulator that emits both UVA and UVB radiation. The submissions point
out that sunburn is not caused solely by UVB radiation. It is well
known that UVA radiation contributes up to 20 percent of the skin's
sunburn response (Refs. 5 and 6). One submission points out that if a
sunscreen product blocked 100 percent of the incident UVB radiation and
none of the erythemally effective UVA radiation, the sunscreen product
would have SPF values no higher than 11 (if only 9 percent or 1/11 of
UV radiation reaches the skin) (Ref. 4).
    We agree that UVA radiation contributes to the development of
sunburn. Although the contribution of UVA to sunburn is less than UVB,
it is still significant (Ref. 5). Further, as stated in the
submissions, protection against UVA radiation is necessary to achieve
higher SPF values (Ref. 5). We proposed including the term ``UVB'' in
the SPF statement in the 2007 proposed rule to help consumers
understand that the SPF effectiveness rating is different from the UVA
effectiveness (star) rating being proposed (72 FR 49070 at 49084).
However, as discussed elsewhere in this final rule we are not requiring
a UVA effectiveness rating on the PDP (see section III.B.). Therefore,
the term ``UVB'' is not necessary as part of the SPF statement. In this
final rule, we are not requiring the term ``UVB'' be placed before the
term ``SPF.''
    In the 2007 sunscreen proposed rule, we stated that the SPF value
should be followed by one of the descriptors ``low,'' ``medium,''
``high,'' or ``highest'' (proposed 21 CFR 352.50(a)). The proposed
descriptors were included to help consumers understand the SPF value
because the label would have included identical descriptors for the UVA
star rating. As discussed in section III.B. of this document, we are
not requiring a UVA effectiveness rating on the PDP. Therefore,
descriptors are no longer required to distinguish the SPF value from
the UVA rating on a sunscreen label. Because we are not requiring a
descriptor after the SPF value on the PDP in this document, the request
to include SPF 50 sunscreen products in the ``highest'' category is no
longer relevant.
    We received two other requests for revision to the SPF statement
with which we do not agree. First, a submission stated that SPF values
should only be labeled in multiples of five to be consistent with SPF
labeling recommendations by the European Commission (Ref. 7). Second,
one request from a submission suggested that SPF values should be
expressed as the percent of UV absorption. The submission argued that
the current SPF values are misleading because consumers believe an SPF
15 sunscreen product is not very protective even though it screens 93
percent of UV radiation.
    We do not agree with either submission. Based on SPF test data we
have reviewed, we find that SPF values for sunscreen products generally
can be determined with a precision that allows the products to be
labeled with SPF values in intervals of less than 5 units (Ref. 1).
Therefore, there is no mathematical or statistical basis for
restricting SPF values to multiples of five. Contrary to the second
request, consumers have relied on SPF values for over 30 years and are
familiar with this format. Therefore, expressing SPF values as
percentages may be confusing. It would imply that the stated percentage
of the entire UV spectrum is absorbed by a sunscreen. However, the SPF
values only reflect protection against the portion of the UV spectrum
that causes sunburn. Additionally, the percentages of UV radiation
screened that the submission notes are theoretical. The percentages are
determined in a laboratory setting and not under actual use conditions.
For example, laboratory tests may show that an SPF 15 sunscreen absorbs
93 percent of UV rays, but, under actual use conditions, the level of
protection provided by an SPF 15 sunscreen product may be significantly
below 93 percent. There are a number of factors

that lead to this decreased protection, the most important being under-
application of the sunscreen product (72 FR 49070 at 49092). Therefore,
if SPF values were expressed as percentages, consumers might mistakenly
believe that the sunscreen products they are using provide more
protection than they really do provide under actual use conditions.

B. Broad Spectrum Statement

    In response to the 2007 proposed rule, we received over 50
submissions collectively making the following four requests regarding
the UVA effectiveness rating (Ref. 1):
    1. Do not require UVA 4-star rating system.
    2. Do not require ``no UVA protection'' statement if a product does
not protect against UVA radiation.
    3. Do not require the UVA statement to be the same size as the SPF
statement.
    4. Perform label comprehension studies prior to implementing
proposed PDP labeling.

The submissions included arguments, but no data, to support these
requests.

    We agree with the first and second requests. However, we are not
granting the third and fourth requests. Our reasons for these decisions
are explained below, but we first summarize the related provisions of
this final rule. We are not requiring a star rating or descriptors to
indicate the level of UVA protection as proposed. Instead, to indicate
the level of UVA and UVB protection, we are establishing a pass/fail
broad spectrum test and a broad spectrum labeling statement. If a
sunscreen product passes the broad spectrum test (see section VIII.B.
of this document), under this final rule, the PDP of the product must
include the statement ``Broad Spectrum SPF [insert numerical SPF value
resulting from testing under paragraph (i) of this section],'' without
any ``UVA'' reference (Sec.  201.327(a)(1)(i)). We are requiring the
Broad Spectrum SPF statement to appear as continuous text with no
intervening text or graphics. We are also requiring that the entire
text be the same font style, size and color on the same background
color. (Sec.  201.327(a)(1)(ii)).
    With regard to the submissions received, nearly all of the 50+
submissions argued against requiring the 4-star rating system to
display the level of UVA protection on the PDP of OTC sunscreen
products (Ref. 1). Many submissions stated that the presence of stars
and a number (SPF) on the PDP will lead to consumer confusion. Some
submissions argued that consumers may be confused when determining
whether a star is filled or empty, thereby not knowing the UVA
protection level. Other submissions argued that consumers are familiar
with star ratings, but that the star rating for items such as movies
and hotels are based on recommendations and not rigorous data. They
suggested several options for labeling UVA protection, such as a
numerical rating or another symbol other than stars.
    Some submissions suggested that the UVA rating should be
proportional to the SPF value but requested that there not be two
ratings on the PDP. The submissions cited the European Commission's
recommendation that UVA protection increase as the SPF value increases
(Ref. 7). The European Commission recommends a minimum UVA protection
factor equal to at least one-third of the labeled SPF or a critical
wavelength of at least 370 nm, but does not recommend that the actual
value of the UVA protection factor or critical wavelength be displayed.
The European Commission recommends that the main indicator of sun
protection be the SPF value. Broad spectrum protection is indicated by
a symbol on sunscreen labels--the acronym ``UVA'' enclosed within a
circle the diameter of which should not exceed the height of the SPF
value.
    We agree with the submissions that the UVA star rating would likely
be confusing in conjunction with the numerical SPF rating. We also
agree with the submissions requesting that UVA protection should be
proportional to the SPF value. We are requiring such proportionality in
the broad spectrum test described in this document. Because of this
proportionality, there is no longer a need for a separate UVA rating.
Instead of a rating, we are requiring a ``broad spectrum'' statement on
the PDP if a product has a critical wavelength equal to or greater than
370 nm. This pass/fail ``broad spectrum'' statement is consistent with
the recommendations in the submissions citing the recommendations of
the European Commission.
    As noted, several submissions responding to our proposal for a
separate UVA rating with stars suggested that consumer comprehension
testing should be performed before the proposed labeling is
implemented. We agree with the submissions that consumer comprehension
data can be very helpful in formulating labeling changes. In fact, in
conjunction with our 1993 proposal to allow products to be labeled as
``broad spectrum'' if they contained sunscreen active ingredients that
absorbed UVA radiation (58 FR 28194 at 28233), we requested label
comprehension study data to allow us to determine consumer
understanding of the terms ``broad spectrum,'' ``UVA,'' and ``UVB'' (58
FR 28194 at 28243). Unfortunately, the data we received were not
sufficient to allow us to determine the level of consumer understanding
of these terms (72 FR 49070 at 49081 through 49085), and we received no
further consumer comprehension data in response to the 2007 proposal to
require the UVA star rating. While we acknowledge the value of consumer
comprehension data, for reasons explained below, we conclude that
conducting consumer comprehension testing is not necessary in this case
in light of the labeling we have selected for the final rule.
    First, submissions suggesting consumer testing were responding to
the UVA star rating in the proposed rule, the value of which would have
been based on the results of two tests (72 FR 49070 at 49081 through
49085). As noted, we agree with the submissions suggesting that the
2007 UVA labeling proposal was likely to be confusing. Elsewhere in the
document, we also discuss our final choice of a pass-fail test for
establishing UV protection (section VIII.B). As a result of these
changes in the underlying test method and the submissions on the
proposed labeling, we have incorporated a much simpler labeling
statement in this final rule. This statement designates as ``broad
spectrum'' those products that are demonstrated to have a critical
wavelength of at least 370 nm, using the test in new 21 CFR 201.327(j).
    Second, unlike in 1993 when we first sought consumer data on the
term ``broad spectrum'', and unlike the UVA star rating that we
proposed in 2007, consumers are now likely to be familiar with the term
``broad spectrum'' as included in this document because some sunscreen
manufacturers have labeled sunscreen products as ``broad spectrum'' for
over 20 years. For example, the Johnson and Johnson ``Sundown Broad
Spectrum'' line of sunscreens was on the market in 1988 (Ref. 8). As
already noted, in our 1993 proposed rule, we not only sought consumer
data, but in fact proposed that products be permitted to be labeled as
``broad spectrum'' if they contained sunscreen active ingredients that
absorbed UVA radiation, although we did not at that time propose to
require a specific test to demonstrate UVA protection (58 FR 28194 at
28233). We continued to allow this statement in the 1999 sunscreen
final rule (64 FR 27666 at 27666 through 27667).
    Many consumers may also be familiar with the term ``broad
spectrum'' because

of public health campaigns and news articles about the importance of
broad spectrum UV protection over the last two decades. For example, an
article appearing in Working Woman magazine in 1990 urged women to
``make sure to look for the term `broad spectrum' on the label of a
sunscreen'' because ``it means you're getting protection from both
types of radiation'' (Ref. 9).
    For consumers not already familiar with the term ``broad
spectrum,'' the additional indication statement allowed in this
document for certain broad spectrum sunscreen products should help
consumers recognize the benefit of these products. Under ``Uses'' in
Drug Facts, broad spectrum sunscreen products with an SPF value of 15
or higher are allowed the following indication statement: ``if used as
directed with other sun protection measures (see Directions [in bold
italic font]), decreases the risk of skin cancer and early skin aging
caused by the sun'' (new 21 CFR 201.327(c)(2)).
    In addition, educational campaigns about sun protection will
further inform consumers about the benefits of using sunscreens that
include the term ``broad spectrum'' on their labels and have an SPF
value of 15 or higher. We expect consumers to learn that a sunscreen
labeled with the statement ``Broad Spectrum SPF'' 15 or higher, when
used as directed with other sun protection measures, offers more
comprehensive protection against sun-induced skin damage than that
provided by a sunscreen that is not broad spectrum or that are broad
spectrum with an SPF value less than 15.
    It is important to note that the broad spectrum test required in
this document captures both UVB and UVA protection for the
effectiveness of a sunscreen product. The broad spectrum test is not
limited to UVA wavelengths as was the case with the proposed test (see
section VIII.B of this document). By requiring that a broad spectrum
sunscreen provide both UVB and UVA protection in a pass/fail test, the
amount of UVA protection for a sunscreen product that passes the test
must increase as the SPF increases. For example, a Broad Spectrum SPF
40 sunscreen product provides greater protection against both UVB and
UVA than a Broad Spectrum SPF 20 sunscreen product. In contrast, an SPF
40 sunscreen product that is not broad spectrum provides more UVB
protection than a SPF 20 sunscreen product that is not broad spectrum,
but may not provide more UVA protection.
    This proportionality between UVB and UVA protection is important
because consumers have been accustomed to basing their purchase
decision concerning protection level primarily on the SPF value, and
only secondarily on indications of whether or not the sunscreen
provides broad spectrum protection. For example, a consumer seeking
lower protection may have chosen an SPF 15 sunscreen product, whereas a
consumer seeking higher protection may have chosen an SPF 40 sunscreen
product. By creating a clear and standardized ``yes/no'' indicator
regarding broad spectrum protection, these final labeling requirements
will enable consumers to make better and more informed purchase
decisions by looking to see if a product has a ``Broad Spectrum SPF''
value on the label. Thus, the ultimate purchase decision would be based
on the numerical value associated with the Broad Spectrum SPF
statement. For products offering broad spectrum protection, the Broad
Spectrum SPF value on the PDP will not only indicate the relative level
of protection against UVB radiation but will also reflect the level of
UVA protection, with increasing SPF values indicating greater
protection against both UVA and UVB radiation. For broad spectrum
products, linking the amount of UVA protection to the SPF value, is
consistent with the approach taken in Europe (Ref. 7).
    For broad spectrum products, we are requiring the broad spectrum
statement on the PDP to appear in combination with the SPF statement.
For example, an SPF 40 sunscreen product which passes the broad
spectrum test will be labeled ``Broad Spectrum SPF 40'' in a uniform
font style, size, and color and with the same background color. This
placement will help consumers recognize that the particular sunscreen
product is broad spectrum in conjunction with the SPF value. As
previously explained, the broad spectrum statement and SPF value
together will provide a relative measure of both UVB and UVA
protection. Combining the broad spectrum and SPF statements will help
consumers become more aware of the importance of broad spectrum
protection.
    Under the 2007 proposed rule, if an OTC sunscreen product was not
tested for or did not protect against UVA radiation, the statement ``No
UVA protection'' would have been required on the PDP (proposed 21 CFR
352.50(b)(1)). Ten submissions argued against requiring this statement
(Ref. 1). Some submissions argued that this statement is misleading
because all sunscreen products provide some UVA protection. Submissions
also stated that a negative statement is inconsistent with the OTC Drug
Review because a drug should only describe the indications for which it
is effective. Other submissions suggested that we should require all
sunscreen products to provide UVA and UVB protection, making this
statement unnecessary.
    We have concluded that the ``No UVA Protection'' statement is not
necessary and could be misleading. Under this final rule, the labeling
on the PDP of sunscreens no longer refers the type of UV radiation (UVA
or UVB) protection offered; rather, products that pass the critical
wavelength test in 201.327(j) are labeled with ``Broad Spectrum SPF''
values. Under this labeling, consumers who see ``UVA'' on the PDP, even
if it is part of the statement ``No UVA Protection,'' may mistakenly
believe that the product offers UVA protection. To eliminate this
potential misunderstanding, we are not including the ``No UVA
Protection'' statement on the PDP.
    In contrast to four submissions requesting that we make the UVA
statement less prominent than the SPF statement, we are requiring the
SPF and broad spectrum statements to be equally prominent on the PDP by
appearing as a combined statement. The four submissions stated that
they believe UVB radiation contributes more to skin cancer and
photodamage than UVA radiation and argued that more prominence should
be given to the SPF statement. However, none of the submissions
included data to support this argument. Some submissions suggested that
consumers are familiar with SPF ratings and that providing another
rating with similar prominence may mislead and confuse consumers.
    It is well known that both UVA and UVB radiation contribute to
photodamage and skin cancer (Refs. 6-7 and 10-12). Therefore, in our
view, providing consumers with information about the effectiveness of a
sunscreen product for UVA and UVB radiation protection is equally
important. We are requiring that the broad spectrum statement be
displayed in combination with the SPF statement. The two statements
must not be interrupted with any graphics or text. In addition, the
broad spectrum statement must be the same font style, size, and color
as the SPF statement with the same background color. It is important
for consumers to evaluate both statements when making a purchase
decision. By requiring this information to be presented with identical
prominence on the PDP, consumers should be able to quickly and easily
identify sunscreen products that provide broad spectrum protection, as
well as the SPF of all sunscreen products. While we are not requiring a
negative statement on the

PDP of products that do not pass the critical wavelength test in new
301.327(j), we caution that such products may be misbranded if they
include statements regarding UVA protection; such statements may
misleadingly imply that the product provides benefits that are similar
or superior to those of products labeled with Broad Spectrum SPF
values.

C. Water Resistance Statement

    In the 2007 sunscreen proposed rule (proposed 21 CFR 352.52), we
allowed the PDP of OTC sunscreen products to contain the statement
``water resistant'' if a sunscreen product was shown to retain the
labeled SPF value after 40 minutes of water immersion, or ``very water
resistant'' if a sunscreen product was shown to retain the labeled SPF
value after 80 minutes of water immersion, according to the test in
proposed 21 CFR 352.76. We simultaneously proposed that the ``Uses''
section of labeling (not the PDP) indicate specifically whether the
product had been established to be water resistant for 40 minutes or 80
minutes, and included specific directions addressing times for
reapplication of each product, dependent on its level of water
resistance (proposed 21 CFR 352.52(b)(1)(vii), (b)(1)(viii), (d)(2),
and (d)(3); 72 FR 49070 at 49113). In this document, we are revising
the PDP to contain the statement ``water resistant (40 minutes)'' or
``water resistant (80 minutes)'' as determined by the water resistance
test in new 21 CFR 201.327(i)(7). We are removing this information from
the indications section of Drug Facts (section IV.B of this document).
We continue to include directions based on the duration of water
resistance established under the new water resistance test (section
IV.D of this document).
    One submission stated that including information about water
resistance in the indications section as well as in the directions
section is ``redundant and confusing'' (Ref. 1). The submission
recommended that we delete the indications statement. We agree with the
submission. To eliminate redundancy and simplify the labeling for
consumers, we are relocating the information formerly contained within
the indication statement to the PDP.
    The content of the labeling as a whole is the same as that included
in the 2007 proposed rule. However the proposed statement on the PDP
did not clearly and accurately convey to consumers the difference
between ``water resistant'' and ``very water resistant'' sunscreen
products. For example, knowing that a sunscreen product is ``very water
resistant'' does not give any indication of how much time a consumer
can safely spend in the water. Under the 2007 proposed rule, a consumer
would have had to read either the ``Uses'' or the ``Directions''
section of the Drug Facts label to determine the duration of water
resistance for a sunscreen product (proposed 21 CFR 352.52(b)(1)(vii)
and (b)(1)(viii) and proposed 21 CFR 352.52(d)(2) and (d)(3),
respectively; 72 FR 49070 at 49113).
    Providing, on the PDP, specific information about the actual time
(40 or 80 minutes) a consumer can expect a sunscreen product to retain
its labeled SPF value is likely to be more helpful to consumers because
the information is displayed in one place--on the PDP and not on
different parts of the labeling. The revised statements ``water
resistant (40 minutes)'' or ``water resistant (80 minutes)'' should
make it clearer and easier for consumers to understand water resistance
as part of their purchase decision. This water resistance information
continues to be reinforced by information in the directions regarding
reapplication.

D. UVB and UVA Educational Statement

    In the 2007 sunscreen proposed rule, we proposed that the following
educational statement be included on the PDP of all OTC sunscreen
products (proposed 21 CFR 352.50(c)): ``UV rays from the sun are made
of UVB and UVA. It is important to protect against both UVB and UVA
rays to prevent sunburn and other skin damage.''
    We received four submissions regarding the UVB and UVA educational
statement in response to the 2007 sunscreen proposed rule (Ref. 1). The
submissions made the following requests:
     Do not require the educational statement on the PDP or
     Combine the educational statement with the sun alert
statement and include the combined statement in the ``Other
Information'' section of the Drug Facts label.
    We considered including the proposed educational statement on the
PDP. We concluded that this information is not critical for effective
use of sunscreen products, particularly since we are no longer
requiring other PDP statements to refer separately to UVA and UVB
protection. An understanding that the sun produces ultraviolet (UV)
rays or that there are two types of UV rays that reach the earth's
surface is not necessary to ensure the safe and effective use of
sunscreen products. The explanation of these concepts on sunscreen
labeling is potentially confusing and could raise additional questions
about their meaning. We could not determine a succinct educational
statement that would not also be potentially misleading. Therefore, we
have concluded that an educational statement should not be required on
the PDP.
    As noted, submissions also requested that the proposed educational
statement be combined with proposed sun alert, included in the proposed
rule as a warning. In section IV.C of this document, we address
submissions on the sun alert warning, and explain our decision to
incorporate the information regarding the role of certain sunscreens in
reducing the risk of skin cancer and early skin aging into a new
indication and accompanying directions for sunscreens with Broad
Spectrum SPF values of 15 or higher. We are retaining a modified
warning to be included as the first warning on sunscreen products that
are either not broad spectrum or that are broad spectrum with an SPF
value less than 15. Because we are not requiring an educational
statement on the PDP and are either eliminating or modifying the
proposed sun alert warning, the request to combine these two statements
is no longer relevant.

IV. Drug Facts Labeling

    In September 2004 (69 FR 53801), we delayed the May 16, 2005,
implementation date for the Drug Facts final rule (21 CFR 201.66) for
OTC sunscreen products until further notice). The Drug Facts final rule
(21 CFR 201.66) establishes general labeling format and content
requirements for all OTC drugs. With the additional exception of
certain OTC drug products in ``convenience size'' packages (see 67 FR
16304 at 16306 (April 5, 2002), other OTC drug products are already
required to comply with 201.66. We delayed implementation of 201.66 for
sunscreens so as to avoid the potential that sunscreen manufacturers
would have to relabel their products twice within a short time period
if a final rule specifying labeling for sunscreens published shortly
after the original May 2005 implementation date for the general content
and format requirements of the Drug Facts final rule. We published the
notice of delay for OTC sunscreens' implementation of the Drug Facts
final rule so that such products could simultaneously implement both
the general labeling provisions of that rule and the specific labeling
provisions for sunscreens when we published a sunscreen labeling final
rule. We are now lifting the stay on the implementation of the Drug
Facts final

rule for OTC sunscreen products. In this document, we are requiring the
same implementation date for the regulations set forth in this labeling
and testing final rule (21 CFR 201.327) and in the Drug Facts final
rule (21 CFR 201.66) as applied to these sunscreen products.
    This action will benefit both consumers and manufacturers.
Consumers will benefit by having sunscreen labeling presented in the
Drug Facts format that they are familiar with. Manufacturers benefit
because they will achieve compliance with two rules through one
labeling revision (rather than following the more expensive course of
making two labeling changes at two different times).
    In 2003 (68 FR 33362, June 4, 2003), we also stayed the part of the
skin protectant monograph that describes GRASE combinations of skin
protectant and sunscreen active ingredients (21 CFR 347.20(d)). Because
this document addresses the labeling and testing of sunscreen products
and not the GRASE status of individual sunscreen active ingredients, we
are not lifting the stay of 21 CFR 347.20(d).
    This document requires much of the Drug Facts labeling included in
the 2007 proposed rule. However, we have made several revisions to the
proposed labeling. These revisions are discussed in detail throughout
the remainder of this section. In addition, table 2 of this document
summarizes these revisions as follows:

                             Table 2--Summary of Drug Facts Labeling Included in the 2007 Proposed Rule and This Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Drug facts section                              2007 Proposed rule                                          This final rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Active Ingredients/Purpose.........  Name and amount of ingredient(s) followed by               Name and amount of ingredient(s) followed by
                                      ``sunscreen''                                              ``sunscreen.''
Uses...............................   [low, medium, high, or highest] UVB sunburn        for all sunscreen products: ``helps prevent
                                      protection                                                 sunburn.''
                                      [low, medium, high, or highest] UVA protection     Optional, for sunscreen products with Broad
                                      retains SPF after 80 minutes of activity in the    Spectrum SPF values of 15 or higher, ``if used as
                                      water                                                      directed with other sun protection measures (see
                                                                                Directions), decreases the risk of skin cancer and
                                                                                early skin aging caused by the sun.''

Warnings...........................  UV exposure from the sun increases the risk of skin        For sunscreen products that are not broad spectrum or
                                      cancer, premature skin aging, and other skin damage. It    for products that are broad spectrum with an SPF value
                                      is important to decrease UV exposure by limiting time in   less than 15, Skin Cancer/Skin Aging Alert [in bold
                                      the sun, wearing protective clothing, and using a          font]: Spending time in the sun increases your risk of
                                      sunscreen.                                                 skin cancer and early skin aging. This product has been
                                                                                shown only to help prevent sunburn, not [in bold font]
                                                                                skin cancer or early skin aging.
                                                                                For all sunscreens:
                                     For external use only                                      For external use only
                                                                                Do not use on damaged or broken skin
                                     Stop use and ask a doctor if skin rash occurs              Stop use and ask a doctor if rash occurs
                                     When using this product keep out of eyes. Rinse with       When using this product keep out of eyes. Rinse with
                                      water to remove.                                           water to remove.
                                     Keep out of reach of children. If swallowed, get medical   Keep out of reach of children. If swallowed, get medical
                                      help or contact a Poison Control Center right away.        help or contact a Poison Control Center right away.
Directions.........................  Non-Water Resistant Product                                Non-Water Resistant Product
                                      apply liberally [ minutes] before sun     apply liberally 15 minutes before sun exposure
                                      exposure                                                   use a water resistant sunscreen if swimming or
                                      reapply at least every 2 hours and after towel     sweating
                                      drying, swimming, or sweating                              reapply at least every 2 hours
                                      apply and reapply as directed to avoid lowering    children under 6 months: Ask a doctor
                                      protection
                                      children under 6 months: Ask a doctor
                                     Water Resistant Product                                    Water Resistant Product
                                      apply liberally [ minutes] before sun     apply liberally 15 minutes before sun exposure
                                      exposure
                                      reapply after 40 [or 80] minutes of swimming or    reapply:
                                      sweating and after towel drying. Otherwise, reapply at     after 40 [or 80] minutes of swimming or
                                      least every 2 hours.                                       sweating
                                      apply and reapply as directed to avoid lowering    immediately after towel drying
                                      protection                                                 at least every 2 hours
                                      children under 6 months: Ask a doctor              children under 6 months: Ask a doctor
                                     Water Resistant and Non-Water Resistant Products           Water Resistant and Non-Water Resistant Products
                                     No statement                                               For sunscreens with Broad Spectrum SPF values of 15 or
                                                                                higher:
                                                                                Sun Protection Measures [in bold font].
                                                                                Spending time in the sun increases your risk of skin
                                                                                cancer and early skin aging. To decrease this risk,
                                                                                regularly use a sunscreen with a Broad Spectrum SPF
                                                                                value of 15 or higher and other sun protection measures
                                                                                including:
                                                                                limit time in the sun, especially from 10 a.m.-
                                                                                2 p.m.
                                                                                wear long-sleeved shirts, pants, hats, and
                                                                                sunglasses.
Inactive Ingredients...............  List inactive ingredients in alphabetical order            List inactive ingredients in alphabetical order.
Other Information..................  No required statements                                      protect this product from excessive heat and
                                                                                direct sun.
Questions?.........................  No required statements                                     No required statements.
--------------------------------------------------------------------------------------------------------------------------------------------------------

A. Active Ingredients/Purpose

    We received one submission regarding the listing of active
ingredients and one submission requesting that we provide specific
details about what each ingredient does in the product (Ref. 1). One of
these submission also requested that we require listing of the
percentage of each active ingredient next to the ingredient name.
    We are not making any changes to the ``Active ingredients/Purpose''
section of the Drug Facts label. The general OTC labeling regulations
specify that the ``quantity of each active ingredient per dosage unit''
be listed with the established name of each active ingredient (21 CFR
201.66(c)(2)). Therefore, every sunscreen product is already required
to include the active ingredient names followed by the percentage
(weight per volume) in the ``Active ingredients/Purpose'' section, as
requested by the first submission.
    We are not requiring specific details about what each ingredient
does in the product. The function of each active ingredient in an OTC
drug product is already required to be listed by 21 CFR 201.66(c)(3),
which specifies that the ``Active ingredients/Purpose'' section of the
label list the ``general pharmacologic categories or principal intended
actions of each active ingredient.'' There is not currently a
requirement to list the purpose of inactive ingredients on OTC drug
labels. This information is not needed to safely and effectively use
sunscreen products. Therefore, in this document, we are not requiring
the purpose of inactive ingredients to be listed on sunscreen labels.

B. Uses

1. Indications Statements Proposed in the 2007 Proposed Rule
    The 2007 proposed rule included three indication statements under
``Uses'' in Drug Facts:
    1. Level of UVB sunburn protection (proposed 21 CFR
352.52(b)(1)(i)-(b)(1)(iv))
    2. Level of UVA protection (proposed 21 CFR 352.52(b)(1)(v) and
(b)(1)(vi))
    3. Extent of water resistance (proposed 21 CFR 352.52(b)(1)(vii)
and (b)(1)(viii))

The first statement would have appeared on all monograph sunscreen
products. The second statement would only have appeared on monograph
sunscreen products providing UVA protection. The third statement would
only have appeared on monograph sunscreen products that are water
resistant for either 40 or 80 minutes. We received numerous submissions
from the public concerning these statements following publication of
the 2007 proposed rule (Ref. 1).

    We are not requiring these indication statements in this final
rule. Instead, all sunscreen products covered by this rule will be
required to include the indication statement ``helps prevent sunburn,''
as required in the 1999 sunscreen final rule (64 FR 27666; new 21 CFR
201.327(c)(1)). We are requiring this statement instead of the first
proposed statement (level of UVB sunburn protection) because we agree
with submissions arguing that sunburn is not caused solely by UVB
radiation (Ref. 1). We also agree with submissions arguing that the SPF
value by itself on the PDP informs consumers of the level of sunburn
protection, so a separate description of the level of sunburn
protection does not need to be included as an indication.
    In addition, sunscreen products covered by this rule that provide
broad spectrum protection according to the test in new 21 CFR
201.327(j) and have SPF values of 15 or higher, may include the
following indication statement (new 21 CFR 201.327(c)(2)(i)): ``if used
as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the
sun.'' This statement replaces the second proposed indication
statement. We are allowing this statement for certain sunscreens
covered by this rule based on available clinical studies, the fact that
UV radiation from the sun is harmful, and the scientific understanding
that substantially limiting overall UVB and UVA exposure reduces the
risk of skin cancer and early skin aging.
    As discussed in the remainder of this section of the document, it
is critical that the indication statement regarding skin cancer and
early skin aging includes information about using the products as
directed and following other sun protection measures (listed under the
heading Directions). We have concluded that the reference to other sun
protection measures is necessary to ensure that the consumer's overall
UV exposure is substantially decreased. A consumer who relies on the
use of a sunscreen with Broad Spectrum SPF value of 15 or higher alone
may not obtain a meaningful net decrease from the risk of skin cancer
or early skin aging if, because he or she is wearing the sunscreen, the
consumer spends more time in the sun and/or wears less protective
clothing. In fact, reliance on sunscreen use alone, without also
employing other sun protection measures, could actually result in an
increase in the consumer's overall UV exposure. Therefore, if the
indication statement regarding decreasing risk of skin cancer and early
skin aging does not include the information about using the product as
directed, which includes following other sun protection measures, the
statement will be considered misleading (and thus make a sunscreen
product misbranded) (new 21 CFR 201.327(c)(3)). Similarly, sunscreen
products covered by the rule that provide broad spectrum with SPF
values between 2 and 15 or do not provide broad spectrum protection
should not state or imply that the use of a sunscreen product alone
will reduce the risk of skin cancer or early skin aging. Doing so would
cause the product to be misbranded.
    We are not including the third proposed indication statement
(regarding water resistance) in this document. As already discussed,
under this final rule, information about water resistance is included
on the PDP, as well as under ``Directions'' in Drug Facts (see sections
III.C and IV.D of this document). We conclude that information about
the water resistance of a sunscreen product is more effectively and
accurately presented on the PDP and as a direction than as an
indication statement. The extent of water resistance informs a consumer
about how long the SPF value is retained following water exposure and,
therefore, how long an interval can elapse before reapplying the
sunscreen product (40 or 80 minutes). In addition, the PDP requirements
in this document include the time interval as part of the water
resistance statement, so that consumers can readily distinguish between
products on this basis when making purchasing decisions. Because we
include water resistance on the PDP and under ``Directions,'' we are
not including a separate indication statement about water resistance in
this document.
2. Statement Regarding Skin Cancer and Early Skin Aging
a. Submissions Arguing For a Skin Cancer and Early Skin Aging
Indication
    As already stated, in this final rule we have adopted, for the
first time, an indication for skin cancer and early skin aging for
sunscreen products covered by the rule that have Broad Spectrum SPF
values of 15 or higher. In our 2007 proposed rule, we had included
indication statements that indicated the degree of protection against
both UVB and UVA radiation but that linked UVB protection only to
sunburn prevention and did not expressly link UVA

protection to any specific health benefit (proposed 21 CFR 352.52(a)).
At the same time, however, we had proposed both an educational
statement on the PDP stating that UV rays from the sun are made of both
UVB and UVA and that it is important to protect against both types of
radiation to prevent sunburn and other skin damage (proposed 21 CFR
352.50 (c)). We also proposed a ``sun alert'' statement as the first
warning. This first warning read, ``UV exposure from the sun increases
the risk of skin cancer, premature skin aging, and other skin damage.
It is important to decrease UV exposure by limiting time in the sun,
wearing protective clothing, and using a sunscreen.'' (proposed 21 CFR
352.52(c)(1)).
    In response to our proposed rule, we received a total of 12
submissions asking that we include a specific statement regarding
reduction in risk of skin cancer and early skin aging as an indication
for covered sunscreens (Ref. 1). The submissions asked that we allow an
indication statement informing consumers that the regular, consistent,
or continued use of a sunscreen product reduces or helps reduce the
risk or chance of developing skin damage, early skin aging, and some
types of skin cancer (Ref. 1). These submissions also supported our
proposed requirement of a ``sun alert'' on the labeling to inform
consumers of the need to limit time in the sun and wear protective
clothing. The submissions came from sunscreen manufacturers and public
health organizations including the American Academy of Dermatology, the
American Cancer Society, and the Skin Cancer Foundation. Many of the
submissions provided references to studies that they argued support the
inclusion of this indication statement. One submission specifically
requested that we allow an anti-aging claim (without mention of skin
cancer), and one other submission argued that no sunscreen can claim to
prevent cancer (Ref. 1). We received no new data to accompany these
requests for a separate indication that the regular use of sunscreen
decreases the risk of skin cancer and early skin aging. However, on
reconsideration of the data reviewed prior to the 2007 proposed rule,
we agree with the argument that the data underpinning our proposed
education statement and warning are sufficient to support an
appropriately qualified skin cancer and premature skin aging indication
for one subset of sunscreens covered by this rule--those that have
Broad Spectrum SPF values of 15 or higher. As a result, our final rule
provides different labeling for these sunscreens than for sunscreens
covered by the rule that are not broad spectrum or that provide broad
spectrum with SPF values less than 15. In addition, we conclude that
such an indication should not be included in the Warnings section of
Drug Facts. We have concluded that, as proposed in 2007, the second
sentence of the first warning (i.e., the ``Sun Alert'' warning) is an
implied indication: ``It is important to decrease UV exposure by
limiting time in the sun, wearing protective clothing, and using a
sunscreen.'' Because it follows a warning that ``UV exposure from the
sun increases the risk of skin cancer, premature skin aging, and other
forms of skin damage,'' the second sentence implies that using any
sunscreen, regardless of SPF value or broad spectrum protection, and
following other sun protection measures will decrease the risks of skin
cancer, early skin aging, and other consequences of UV exposure to the
sun. We have concluded, based on a reconsideration of data previously
reviewed in the 2007 proposed rule, that, if consumers use broad
spectrum sunscreens with SPF values of 15 or higher and follow other
sun protection measures, they can reduce their risk of skin cancer and
early skin aging. For these products, we agree with the public
submissions that this information is most appropriately placed as an
indication (i.e., under Uses) with a reference to the need to use the
product as directed with other sun protection measures. For these
products, we include under the heading Directions, specific reference
not only to regularly use sunscreens with Broad Spectrum SPF values of
15 or higher (the subset of sunscreens for which the indication is
allowed) but also to employ the other listed sun protection measures
listed under Directions. For sunscreen products covered by this rule
that are not Broad Spectrum or that are broad spectrum with an SPF
value less than 15, however, we conclude that existing data are
insufficient to support an indication for reducing risk of skin cancer
or early skin aging. In the sections that follow, we explain the
specific scientific basis for our conclusion, as well as explain our
rationale for the specific framing of the labeling, as included in the
final rule, for both subsets of the sunscreens covered by the final
rule--those that have Broad Spectrum SPF values of 15 or higher and
those that do not have Broad Spectrum or that are Broad spectrum with
SPF values less than 15.
b. Limiting Overall UV Exposure Reduces Risk of Skin Cancer and Early
Skin Aging
    For drugs subject to OTC monographs, like sunscreen products,
indication statements about the effectiveness of the drug products must
be supported with scientific data (21 CFR 330.10(a)(4)(ii)). In order
for an OTC drug to be considered generally recognized as effective
(GRAE), there must be a reasonable expectation that, in a given
proportion of the target population, the drug will provide clinically
significant relief of the type claimed (21 CFR 330.14(a)(4)(ii)). Based
on the available data concerning the harmful effects of UV radiation
and sunscreen UV protection, we have concluded that sunscreens, in
conjunction with the critical behavioral steps of limiting time in the
sun particularly during the midday hours and wearing protective
clothing (long sleeve shirt, pants, hat, and sunglasses), provide
``clinically significant relief'' in reducing the risk of skin cancer
and early skin aging. Based on the available data, we have limited this
claim to broad spectrum sunscreen products with an SPF value of 15 or
higher.
    UV radiation from the sun has been associated with nonmelanoma skin
cancers since 1927 and with melanomas since 1952 (Ref. 13). It is
estimated that as much as 90 percent of melanomas and nonmelanomas are
caused by sun exposure (Ref. 5). In 1992, the International Agency for
Research on Cancer (IARC), under the auspices of the World Health
Organization, identified UV radiation as a human carcinogen \3\ (Ref.
14). More recently, broad spectrum UV radiation was listed as a human
carcinogen in the National Toxicology Program's 11th Report on
Carcinogens issued in 2005 (Ref. 15). It is important to note that this
report indicates that UVB and UVA radiation across the spectrum are
known human carcinogens, but that either UVB radiation alone or UVA
radiation alone is ``reasonably anticipated to be a human carcinogen.''
This classification is due to the fact that the exact wavelengths of UV
radiation that cause different harmful effects (e.g., DNA damage or
loss of skin elasticity) have not yet been identified. It is clear,
though, that broad spectrum UV radiation causes skin cancer. Broad
spectrum UV radiation has also been shown to cause other types of skin
damage, including early skin aging (Refs. 6 and 16). Therefore, we
agree

with the principle that a reduction, of sufficient magnitude, in broad
spectrum UV exposure should reduce the risk of harmful effects to the
skin, including skin cancer and early skin aging.
---------------------------------------------------------------------------

    \3\ A carcinogen is anything that is known to cause the
development of cancer. UV radiation is known to cause skin cancer.
---------------------------------------------------------------------------

    Broad spectrum sunscreens, by absorbing UVA and UVB radiation,
decrease consumer exposure to both types of UV radiation from the sun
that reach the earth's surface. Other critical behavioral steps, such
as limiting time in the sun and wearing protective clothing, also
decrease consumer exposure to UVA and UVB radiation. After considering
the submissions and other available data, we have concluded that a
claim for the reduction in risk of skin cancer and early skin aging is
appropriate for certain sunscreen products, when the claim also
includes the requirement that consumers use the product as directed and
the Directions specify other sun protection measures be followed (see
section IV.D of this document). We are basing this claim on the
scientific understanding of the harm from UVA and UVB radiation and the
absorption and/or reflection of that UV radiation by broad spectrum
sunscreens, as well as data from studies concerning sunscreen use and
the development of skin cancer or precursors of skin cancer (section
IV.B.2.c of this document).
    For a sunscreen to be effective (i.e., provide ``clinically
significant relief'') in reducing the risk of skin cancer and early
skin aging, consumers must not increase their overall exposure to UV
radiation by overreliance on sunscreen use. Other behavioral factors
could account for such an increase, such as the amount of time spent in
the sun and the use of protective clothing. If consumers rely on
sunscreen use to spend more time in the sun and/or to wear less
protective clothing, then consumers could actually increase their
overall UV exposure, which would eliminate the effectiveness of
sunscreen use in reducing the risk of skin cancer and early skin aging.
    To illustrate this point, it is helpful to consider what has been
termed the ``compensation hypothesis.'' As we noted in the 2007
proposed rule, the compensation hypothesis states that consumers who
wear high SPF sunscreens generally spend more time in the sun and/or
wear less protective clothing (72 FR 49070 at 49086). If the hypothesis
is true, consumers would not reduce their risk of skin cancer or early
skin aging because their overall UV exposure increases, even though a
properly applied (and reapplied) sunscreen absorbs UV radiation and
helps prevent sunburn. We cited two retrospective studies which support
the compensation hypothesis in the 2007 proposed rule (72 FR 49070 at
49086). Reynolds et al. published a study in 1996 finding, in a study
of 509 sixth-graders, that adolescents who used sunscreen on both
Saturday and Sunday of a Labor Day weekend spent significantly more
time in the sun than those who used sunscreen only one day or not at
all (Ref. 17). In the second study, parents of 503 children, aged less
than 2 to 12 years, were surveyed as to parental attitudes about their
children's sun exposure (Ref. 18). The authors reported that
``sunscreen use in children was significantly associated with longer
duration of sun exposure'' (Ref. 18).
    Increased overall UV exposure might, in fact, increase the risk of
skin cancer and early skin aging, despite the proper use of sunscreens.
Likewise, if consumers limit time in the sun, especially during midday,
and wear more protective clothing (such as broad brimmed hats, long
pants, and long sleeve shirts) while outside, but do not use sunscreens
for areas of the skin exposed to the sun (such as parts of face and
neck), then the consumer may not decrease the risk of skin cancer and
early skin aging for sun-exposed areas. For these reasons, for products
that are entitled to include an indication for reducing the risk of
skin cancer and early skin aging, we continue to direct consumers to
follow a comprehensive sun protection program that includes use of
sunscreens with Broad Spectrum SPF values of 15 or higher, limiting
time in the sun, and wearing protective clothing, similar to the sun
protection measures discussed in the 2007 proposed rule (72 FR 49070 at
49089). Nearly identical multi-step behavioral sun protection programs
are advocated by a number of medical and public health organizations,
including the American Academy of Dermatology, the Skin Cancer
Foundation, and the American Cancer Society.
    We have concluded that a comprehensive sun protection approach is
critical to ensure that consumers who are seeking to obtain a reduction
in the risk of skin cancer and early skin aging limit their overall sun
exposure. Without the reduction in consumers' overall UV exposure, even
a sunscreen with Broad Spectrum SPF value of 15 or higher may not be
effective in decreasing the risk of skin cancer and early skin aging.
As discussed below, the available clinical studies do not control for
these behavioral factors and, therefore, do not demonstrate that even
this subset of sunscreens alone reduce the risk of skin cancer and
early skin aging. However, based on the scientific understanding of the
harm from UV exposure and our assessment of the study data, we have
concluded that if consumers use sunscreens with Broad Spectrum SPF
values of 15 or higher, limit time in the sun especially during the
midday hours, and wear protective clothing when exposed to the sun, the
resulting reduction in overall UV exposure will reduce the risk of skin
cancer and early skin aging. Therefore, there is sufficient evidence of
``clinically significant relief'' to justify the indication and related
directions for this subset of products, as set forth in the rule.
However, we conclude that the omission of prominent information in the
indication regarding the need for other sun protection measures would
misbrand the product, as would the omission of the associated direction
specifying these measures. Indeed, it would suggest a different
indication than that which available evidence supports. Consequently,
we have included in this final rule a new provision indicating that
``Any labeling or promotional materials that suggest or imply that the
use, alone, of any sunscreen reduces the risk of or prevents skin
cancer or early skin aging will cause the product to be misbranded
under section 502 of the FD&C Act (21 U.S.C. 352).'' (new 21 CFR
201.327(c)(3)).
c. Available Scientific Data
    We are not aware of any data other than what we reviewed in the
2007 proposed rule that evaluate the effectiveness of sunscreens in
reducing the risk of skin cancer or early skin aging for healthy
subjects. One more recent study, published in 2009, found that regular
use of Broad Spectrum SPF 50+ sunscreen ``may prevent'' the development
of actinic keratoses and non-melanoma skin cancer in immune-compromised
organ transplant recipients (Ref. 19). We have not relied on this study
in reaching our conclusions regarding OTC sunscreens, because we do not
consider the immune-compromised study population to be representative
of the general population.
    We have re-evaluated the data originally reviewed in preparing the
2007 proposed rule to determine whether those data support allowing the
indication for all sunscreen products or only for certain sunscreen
products. Based on our re-evaluation, we have concluded that the data
is supportive of an indication for broad spectrum sunscreens having SPF
values of at least 15. Further, we have determined that, while the
existing evidence does not support a claim for the use of any sunscreen
alone, it does support an indication that the combination of using

a sunscreen with Broad Spectrum SPF value of 15 or higher along with
other sun protection measures, reduces the risk of skin cancer and
early skin aging, consistent with other positions in the 2007 proposed
rule (72 FR 49070 at 49087 through 49090).
    To date, there are no clinical studies demonstrating that use of
any sunscreen alone can prevent skin cancer. There are two prospective
\4\ studies that directly examine the role of sunscreen products in
preventing skin cancer. Although it did not show any difference in
primary endpoints, a large 1999 study conducted in Australia
demonstrated that people who applied a Broad Spectrum SPF 15 sunscreen
product on a daily basis over a 4.5 year period had a lower overall
incidence of one type of skin cancer, squamous cell carcinoma, on the
head, neck, arms, and forearms than study participants who did not
apply sunscreen (28 cases in the broad spectrum sunscreen group vs. 46
cases in the group not using broad spectrum sunscreen) (Ref. 20). In an
extension of that study, van der Pols et al. evaluated the same
population of subjects over an additional 8 years, and found that the
sunscreen users continued to have a statistically significant lower
incidence of squamous cell carcinoma over the entire 12.5 year period
(Ref. 21). Neither study found that daily sunscreen use had any
measurable effect on the most common form of skin cancer, basal cell
carcinoma. Further, we are not aware of any studies examining the
effect of sunscreen use on the development of melanoma, which is the
deadliest form of skin cancer.
---------------------------------------------------------------------------

    \4\ A prospective study is designed to study subjects under pre-
specified conditions. These studies differ from retrospective
studies that try to prove hypotheses by assessing past experiences.
Generally, prospective studies are superior to retrospective studies
in demonstrating drug effectiveness.
---------------------------------------------------------------------------

    Although data from clinical studies addressing the specific end
points of cancer is limited, some prospective studies have evaluated
the effects of regular sunscreen use on the development of surrogate
skin lesions that can be precursors to cancer: actinic keratoses and
melanocytic nevi. A small percentage of actinic keratoses progress to
squamous cell carcinomas (Ref. 22). At least four studies have
demonstrated that the number of actinic keratoses is lower for
individuals regularly using sunscreens with Broad Spectrum SPF values
of 15 or higher (Refs. 23 through 26). We are not aware of any studies
examining the potential effects on surrogate skin lesions of sunscreens
that either are not broad spectrum or are broad spectrum with SPF
values less than 15.
    Two prospective studies have shown that regular use of a Broad
Spectrum SPF 30 sunscreen reduces the risk of developing melanocytic
nevi, which can progress into melanomas (Ref. 22). In a 2000 study,
Gallagher et al. examined the formation of new melanocytic nevi in 393
Canadian school children. The group of children given Broad Spectrum
SPF 30 sunscreen product had fewer new nevi over the course of the
three year study than did children not given sunscreen products or
advice on sunscreen use (Ref. 27). The difference was small (24 v. 28
nevi, respectively), but statistically significant (p = 0.048). In a
follow-up study published in 2005, Lee et al. evaluated the same group
of children for differences in melanocytic nevi by location on the body
and demographic factors (Ref. 28). These investigators found that the
sunscreen group had significantly fewer new nevi on the trunk than the
control group (p = 0.05).
    With respect to the role of sunscreen products in decreasing the
risk of early skin aging, we are aware of only indirect evidence that
sunscreen use decreases early skin aging. One recent study demonstrated
that a broad spectrum sunscreen product can reduce the extent of solar
UV-induced damage to factors associated with early skin aging even when
the SPF value is less than 10 (Ref. 29). Although this study was small,
evaluating only 12 Caucasian subjects, it shows the importance of broad
spectrum protection. These findings have been corroborated in a large
number of studies using broad spectrum sunscreens with SPF values
ranging from 19 to 50, as reported by Fourtanier et al. in two recent
reviews (Refs. 10 and 30).
    Neither those studies evaluating the long term effect of regular
sunscreen use on the development of skin cancer and early skin aging
nor those evaluating the long term effect of sunscreen use on surrogate
markers for these conditions were adequately controlled. Such studies,
which must take place over many years, make adequate controls extremely
difficult, if not impossible to implement. For example, one cannot
control for time and duration of exposure, application and re-
application amounts, or use of supplemental behavioral measures such as
wearing protective clothing for a study which takes place over several
years.
    Despite their limitation, the results of the short-term
effectiveness studies are consistent with our understanding that
measures which significantly reduce UV exposure decrease the risk of
skin cancer and early skin aging. UVA and UVB radiation is the only
known external risk factor for skin cancer and early skin aging.
Therefore, measures that significantly reduce both UVA and UVB exposure
should decrease the risk of skin cancer and early skin aging. Based on
this understanding, limiting time in the sun, wearing protective
clothing and using a broad spectrum sunscreen with an SPF value of 15
or higher should decrease the risk of skin cancer and early skin aging.
Using a broad spectrum sunscreen with an SPF value of 15 or higher
ensures adequate breadth and magnitude of UVA and UVB protection. For
these products, the broad spectrum test measures breadth and SPF test
measures magnitude of UV protection. Consistent with this scientific
principle, the short-term effectiveness studies demonstrate a decrease
in the development of surrogates for skin cancer and early skin aging.
Thus, we have concluded that the available evidence supports our
finding that sunscreen products, in conjunction with limiting time in
the sun and wearing protective clothing, reduce the risk of developing
skin cancer or early skin aging.
d. Indication Limited to Covered Sunscreens With Broad Spectrum SPF
Values of 15 or Higher
    In light of the submissions requesting that we reframe our labeling
information regarding sunscreen use and reduced risk of skin cancer and
premature skin aging as an indication, we re-evaluated skin cancer and
aging studies discussed in the 2007 proposed rule to determine whether
the skin cancer and early skin aging indication should apply to all
sunscreen products or be limited to certain sunscreen products.
Available data support this indication only for broad spectrum
sunscreens with SPF values of 15 or higher. Several reports have
indicated that UV-induced skin damage associated with both skin cancer
and early skin aging can be reduced by the use of broad spectrum
sunscreens (Refs. 10 and 29 through 31). In a direct comparison of a
broad spectrum sunscreen and a non-broad spectrum sunscreen with the
same SPF, Moyal and Fourtanier found that the broad spectrum sunscreen
provided significantly better protection from UV radiation-induced
immunosuppression, a factor associated with both skin cancer and early
skin aging (Ref. 32). Furthermore, the National Toxicology Program
classified broad spectrum UV radiation as a known human carcinogen
because it is not clear which UVB and/or UVA wavelengths contribute to
the development of cancer (Ref. 15).

Therefore, available data indicate that a broad spectrum sunscreen is
necessary to reduce the risk of skin cancer. Likewise, we do not know
which UVB and/or UVA wavelengths contribute to early skin aging.
Therefore, it is reasonable to conclude that reducing the risk of early
skin aging also requires a broad spectrum sunscreen (in conjunction
with limiting time in the sun and wearing protective clothing).
    With regard to SPF value, the available study data concerning the
use of sunscreens in reducing the risk of skin cancer is based on
products with SPF values of 15 or higher. The sunscreen product used in
the 1999 Australian study on skin cancer (squamous cell and basal cell
carcinomas) had a Broad Spectrum SPF value of 16, and those that were
found to reduce actinic keratoses and nevi had SPF values ranging from
16 to 46. The studies on early skin aging make it difficult to know for
certain whether Broad Spectrum SPF values of 15 or higher are necessary
to reduce the risk of early skin aging. However, we conclude that the
data regarding the minimum sunscreen protection necessary to reduce the
risk of skin cancer can be extrapolated to early skin aging. In many
ways, the biological processes that take place in response to UV
radiation are similar for both conditions. For both skin cancer and
early skin aging, UV radiation causes damage in the skin that is not
completely repaired and leads to cancer, fine lines, wrinkles, etc.
Because the supporting data for a skin cancer claim are based on
products with SPF values of 15 or higher, we are only allowing the skin
cancer and early skin aging claim for covered sunscreen products that
are broad spectrum and have SPF values of at least 15. This rule does
not preclude approval of a new drug application including an indication
for reduction in risk of skin cancer and early skin aging for any
sunscreen product. To be approved, such an application must be
supported by the submission of adequate data. This rule also does not
preclude future amendment of the sunscreen monograph in 21 CFR part
352, if additional data are provided to support a similar indication
for other types of sunscreens.
e. Precedent for an Indication Statement That Includes Behavior
Modification
    There is at least one other OTC drug product with an indication
statement that describes not only the drug's intended effect but also
one or more behavioral measures to ensure the effect. The indication
statement on the weight loss aid orlistat states that the product is to
be used ``for weight loss in overweight adults, 18 years and older,
when used along with a reduced-calorie and low-fat diet'' (Ref. 33).
The behavioral measure of reduced caloric intake is necessary for
consumers to experience weight loss. A low-fat diet is necessary for
consumers to avoid the undesirable side effect of diarrhea caused by
consuming a high-fat diet while taking orlistat.
    The need to include reduced caloric intake as part of the
indication statement for orlistat is similar to the need for including
the use of other sun protection measures as part of the indication
statement for sunscreens. Orlistat increases the likelihood of weight
loss by preventing fat from being absorbed as food is digested in the
stomach and intestines. If consumers take orlistat and decrease their
caloric intake, they increase the likelihood of losing weight. However,
if consumers increase their caloric intake while taking orlistat, they
are less likely to lose weight. Orlistat's effect of preventing fat
absorption could be offset by the high number of calories being eaten.
Similarly, the reduction in UV exposure afforded by use of broad
spectrum sunscreens with SPF values of 15 or higher can be offset if
consumers increase their UV exposure by spending more time in the sun
and/or wearing less protective clothing. This increased overall
exposure could eliminate the effectiveness of sunscreen use in reducing
the risk of skin cancer and early skin aging.
    The labeling of prescription cholesterol-lowering drug products
(i.e., statins) follows a similar principle by emphasizing that
reduction of cholesterol levels requires not only use of the drug
product but also a healthy diet. The National Institutes of Health
(NIH) specifies therapeutic lifestyle changes that can be followed to
lower levels of cholesterol in the blood (Ref. 34). These changes
include following a diet restricted in saturated fat and cholesterol,
exercising regularly, and managing weight. Used in conjunction with
cholesterol reducing drugs (currently available only by prescription),
these lifestyle changes improve the chance of effectively treating high
cholesterol levels.
    Prescription cholesterol-lowering drug products include the
behavioral step of following a low fat diet in the indication statement
(Ref. 35). The body produces cholesterol, which the drug product
inhibits to produce the desired drug effect of lowering cholesterol
being made by the body. However, the total cholesterol circulating in
the blood reflects cholesterol made by the body plus cholesterol
absorbed from foods containing fats. Therefore, if consumers use a
statin and minimize the amounts of food containing fats in their diet,
then they will reduce the total cholesterol level in the blood.
However, if consumers do not minimize the amounts of food containing
fats in their diet, they may not reduce the total cholesterol in the
blood. The decreased cholesterol production in the body caused by the
statin may not be significant compared to the high amount of
cholesterol derived from food eaten by consumers.
    In the same way that regularly taking an OTC weight loss aid or a
prescription cholesterol-lowering drug product without also following a
healthy diet may not result in the intended health effect, use of a
sunscreen with Broad Spectrum SPF value of 15 or higher without also
limiting time in the sun and covering sun-exposed areas may not result
in a net reduction in the risk of developing skin cancer or early skin
aging. For this reason, we are requiring that the indication statement
allowed on sunscreens with Broad Spectrum SPF values of 15 or higher
include all parts of the sun protection program and not suggest or
imply that use of a sunscreen alone reduces the risk of skin cancer or
early skin aging.

C. Warnings

    We received submissions requesting that we revise warnings included
in the 2007 proposed rule and that we add new warnings not included in
the 2007 proposed rule (Ref. 1). In section IV.C.1 of this document, we
discuss one new and one revised warning included in this final rule. We
are adding the new warning ``Do not use on damaged or broken skin''
(new 21 CFR 201.327(d)(1)). We are revising the warning about skin rash
(proposed 21 CFR 352.52(c)(3)): ``Stop use and ask a doctor if skin
rash occurs'' to read ``Stop use and ask a doctor if rash occurs.''
    In section IV.C.2 of this document, we discuss our revision to the
proposed ``Sun Alert'' warning. Under this final rule, the warning
proposed for all monograph sunscreens is replaced with an optional
indication and required direction on covered sunscreens with Broad
Spectrum SPF values of 15 or higher, while covered sunscreens that are
broad spectrum with SPF values less than 15 or that do not provide
broad spectrum protection will bear a revised warning, called the
``Skin Cancer/Skin Aging Alert.'' (new 21 CFR 201.327(d)(2)).
    In section IV.C.3 of this document, we discuss three new warnings
that were requested in submissions, but are not

being included in this document. Submissions argued that we should add
warnings that the regular use of sunscreen products may cause vitamin D
deficiency and may reduce the photoprotective effects of tanning. We
also considered adding a warning concerning sunscreen products
containing alpha hydroxy acids (AHAs). We are not adding any of these
warnings because the available data do not support the need for these
warnings.
    In summary, this document requires the following warnings on all
covered OTC sunscreen products (new 21 CFR 201.327(d)):
     ``Do not use on damaged or broken skin''
     ``Stop use and ask a doctor if rash occurs''
     ``When using this product keep out of eyes. Rinse with
water to remove.''

For all covered sunscreen products that either are not broad spectrum
or are broad spectrum with SPF values less than 15, this final rule
also requires a ``Skin Cancer/Skin Aging Alert'' as the first statement
under the heading Warnings. In addition to these warnings, all
sunscreen products are required to include the ``external use'' and
``keep out of reach of children'' warning statements required on all
topical OTC drug products (21 CFR 201.66(c)(5)(i) and (c)(5)(x)).
1. New and Revised Warnings for Damaged or Broken Skin and Rash
    The new warning that we are requiring on all covered sunscreen drug
products reads, ``do not use on damaged or broken skin.'' We require
this warning or a similar warning for other topical OTC drug products:
     Acne treatments (21 CFR 333.350(c)(3))
     Skin protectants (21 CFR 347.50(c)(6))
     Antiperspirants (21 CFR 350.50(c)(1))

The safety data for these ingredients are based on application to
intact (i.e., unbroken or undamaged) skin. We do not have data of the
safe use of these ingredients if the skin is not intact. For the same
reason, the warning appears on sunscreen products marketed under new
drug applications (NDAs).\5\ Therefore, in this document, we are
requiring this warning for all covered OTC sunscreen products, which
are marketed without approved applications (new 21 CFR
201.327(d)(1)(i)).
---------------------------------------------------------------------------

    \5\ NDAs 21-501, 21-502, 21-471, and 22-009.
---------------------------------------------------------------------------

    In addition to the new warning, we are revising the warning in
proposed 21 CFR 352.52(c)(3): ``Stop use and ask a doctor if skin rash
occurs.'' We are deleting the word ``skin'' so that the new warning
reads: ``Stop use and ask a doctor if rash occurs'' (new 21 CFR
201.327(d)(1)(iii)). We received two submissions arguing that the word
''skin'' is unnecessary in this warning because every rash is a skin
rash (Ref. 1). We agree and are removing the word to make the warning
more concise. Consumers will likely understand the warning without the
word ``skin.''
2. Revision of the Proposed ``Sun Alert'' Warning
    In 2007, we proposed a warning, based on the ``Sun Alert''
statement cited in the 1999 stayed sunscreen final rule (64 FR 27666 at
27679), as the first statement under the heading Warnings for all
monograph sunscreen products regardless of SPF value or broad spectrum
protection (proposed 21 CFR 352.52(c)(1)). As proposed, this warning
would have stated, ``UV exposure from the sun increases the risk of
skin cancer, premature skin aging, and other skin damage. It is
important to decrease UV exposure by limiting time in the sun, wearing
protective clothing, and using a sunscreen.'' Submissions regarding
this proposed warning are discussed in section IV.B.2 of this document.
As noted there, we agree that, as proposed, this warning included an
implied indication that all sunscreens reduce the risk of skin cancer
and skin aging. Under this final rule, we are no longer requiring a
``Sun Alert'' or similar warning on broad spectrum sunscreens with SPF
values of 15 or higher covered by the rule. This decision is based on
our re-evaluation of the available scientific data. We are now
permitting an indication stating that, used as directed with other sun
protection measures, these sunscreens reduce the risk of skin cancer
and premature skin aging (new 21 CFR 201.327 (c)(2)).
    For these products we are also requiring a new direction statement
(new 21 CFR 201.327(e)(1)(iv)). The direction states:

    Sun Protection Measures. [in bold font] Spending time in the sun
increases your risk of skin cancer and early skin aging. To decrease
this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15
or higher and other sun protection measures including: [bullet]
limit time in the sun, especially from 10 a.m.-2 p.m. [bullet] wear
long-sleeved shirts, pants, hats, and sunglasses

    We have concluded that information about decreasing sun exposure
and wearing protective clothing is more appropriate in ``Directions''
than in ``Warnings.'' These measures, in addition to use of a sunscreen
with Broad Spectrum SPF value of 15 or higher, are necessary for the
consumers' sun protection as part of a comprehensive program.
    For covered sunscreen products that do not provide broad spectrum
protection or those that do provide broad spectrum protection with SPF
values less than 15, we conclude that a warning regarding the risks of
skin cancer and skin aging remains necessary. In light of comments
received on the ``Sun Alert'' warning proposed in 2007, however, we are
revising the text to read as follows: ``Skin Cancer/Skin Aging Alert
[in bold font]: Spending time in the sun increases your risk of skin
cancer and early skin aging. This product has been shown only to help
prevent sunburn, not [in bold font] skin cancer or early skin aging.''
(new 21 CFR 201.327(d)(2). The title ``Skin Cancer/Skin Aging Alert''
more accurately and specifically conveys the nature of the warning that
follows than the proposed ``Sun Alert'' warning, particularly since the
products that will bear this statement are indicated to help prevent
sunburn, one consequence of sun exposure. The first sentence of this
warning is a factual statement similar in content to the opening
statement of the warning proposed in 2007. Like the proposed ``Sun
Alert'' warning, this statement alerts consumers to risks they continue
to incur from sun exposure, the conditions under which they will make
use of the product. The second sentence clarifies for users the limits
on the benefits that the product in hand has been established to
provide, specifying that these products have been shown to help prevent
sunburn but have not been shown to reduce the risk of skin cancer or
early skin aging. Inclusion of this warning is critical to help ensure
that consumers do not mistakenly conclude that all sunscreens have been
demonstrated to provide the same benefits. It will reinforce the
distinction between sunscreens indicated only for preventing sunburn
(those that have broad spectrum with SPF values below 15 or that are
not broad spectrum) and sunscreens that have also been shown to reduce
the risk of skin cancer and early skin aging when used as directed with
other sun protection measures (those with Broad Spectrum SPF values of
15 or higher). This warning serves a similar purpose to one required on
cosmetic suntanning preparations that do not contain a sunscreen
ingredient, which likewise is intended to assist consumers in
distinguishing among products that they might otherwise confuse. (See
21 CFR 740.19).

3. Warnings Requested in Submissions But Not Included in This Final
Rule
    We considered adding the following three warnings:
     Sunscreens may reduce the photoprotective effects of
tanning
     Increased sun sensitivity caused by alpha hydroxy acids
(AHAs) in sunscreen products
     Regular use of sunscreen products may cause vitamin D
deficiency

However, as discussed in this section of the document, we conclude that
these warnings are not needed for the safe and effective use of
sunscreen products.

    We received a submission arguing that we should require the
following warning on all OTC sunscreen products containing UVA-
protective active ingredients (Ref. 1): ``The use of this product will
prevent the development of photo-protective facultative pigmentation,
a.k.a., a tan.'' The submission implies that UVA protection is not only
unnecessary but harmful to consumers. No data were included in the
submission.
    We agree that tanning caused by UVA radiation offers some
protection against sunburn. However, tanning, particularly when
attributable to prolonged exposure to UVA radiation in tanning beds or
booths, may also have harmful effects on the skin (Refs. 36 and 37). In
addition, one study suggests that the protective effects of tanning are
small, as a tan only appears to provide an SPF value of approximately 4
(Ref. 36). As stated in the 2007 proposed rule (72 FR 49070 at 49083),
we do not know which UVA wavelengths cause specific types of damage
(e.g., skin cancer or early skin aging). We continue to assert,
however, that protection against UVA radiation is important for
consumers' health (72 FR 49070 at 49083). We have concluded that the
warning suggested in the submission is not in the best interest of
public health because the warning discourages consumers from using
broad spectrum sunscreen products. Therefore, we are not requiring any
warning related to tanning.
    We are not adding any additional warnings to sunscreen products
containing AHAs. In the 2007 proposed rule, we requested comment on the
need for additional warnings or directions on sunscreen products
combined with AHAs (72 FR 49070 at 49110). We made this request in
response to a 2005 guidance that we issued for cosmetic products
containing alpha hydroxy acids (70 FR 1721, January 10, 2005). The
guidance recommends the following warning be included on cosmetic
products containing alpha hydroxy acids: ``Sunburn Alert: This product
contains an alpha hydroxy acid (AHA) that may increase your skin's
sensitivity to the sun and particularly the possibility of sunburn. Use
a sunscreen and limit sun exposure while using this product and for a
week afterwards.''
    Many cosmetic products containing alpha hydroxy acids also contain
sunscreens because the sunscreen helps protect the skin made sensitive
to the sun by the alpha hydroxy acids. The guidance does not address
products combining alpha hydroxy acids and sunscreens.
    Two submissions stated that additional warnings are not necessary
on these products (Ref. 1). We agree with these submissions. We
considered added a warning or other labeling to inform consumers that
AHAs contained in some sunscreen products may make the consumer more
likely to sunburn. However, the sunscreen component of such products
would, in fact, protect consumers from sunburn. Furthermore, we have
concluded that the addition of sunscreen active ingredients to AHA-
containing cosmetic products provides valuable UV protection for
consumers. Therefore, at this time, we have concluded that a warning
about AHA is not necessary on OTC sunscreen products.
    The other new warning requested in submissions relates to vitamin D
deficiency. We received six submissions arguing that consumers should
be warned that frequent sunscreen use may result in vitamin D
deficiency (Ref. 1). The submissions cite articles discussing the
negative effects of vitamin D deficiency, such as growth retardation,
rickets, and osteoporosis (Ref. 38). The submissions include numerous
published articles concerning vitamin D, but only four clinical studies
that directly examine the effect of sunscreen use on vitamin D levels.
In the remainder of this section, we discuss the four studies included
in submissions, as well as three additional studies that we located
through a literature search. Collectively, the studies do not
demonstrate that the use of sunscreen causes vitamin D deficiency.
    The term ``vitamin D'' refers to several forms of the vitamin, but
the two forms important to humans are vitamin D2
(ergocalciferol) and vitamin D3 (cholecalciferol) (Ref. 39).
Vitamin D2 is obtained by eating vitamin D-rich foods such
as fish or food fortified with vitamin D. The skin makes vitamin
D3 when it is exposed to sunlight (Ref. 40) and, therefore,
vitamin D production may vary depending on the following factors: (1)
Skin pigmentation, (2) age, (3) clothing, (4) season, (5) latitude, (6)