I 
113TH CONGRESS 
2D SESSION 
H. R. 4250 
To amend the Federal Food, Drug, and Cosmetic Act to provide an alternative 
process for review of safety and effectiveness of nonprescription sunscreen 
active ingredients and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 13, 2014 
Mr. WHITFIELD (for himself and Mr. DINGELL) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide an alternative process for review of safety and 
effectiveness of nonprescription sunscreen active ingredi-
ents and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Sunscreen Innovation 
Act’’. 
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SEC. 2. REGULATION OF NONPRESCRIPTION SUNSCREEN 
ACTIVE INGREDIENTS. 
Subchapter A of chapter V (21 U.S.C. 351 et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 524B. PROCEDURES FOR CLASSIFYING SUNSCREEN 
ACTIVE INGREDIENTS. 
‘‘(a) IN GENERAL.—The Secretary shall review and 
determine whether nonprescription sunscreen conditions 
are generally recognized as safe and effective and shall 
ensure that any such conditions that are marketed in the 
United States are appropriately labeled. 
‘‘(b) DEFINITIONS.— 
‘‘(1) ACTIVE
INGREDIENT.—The term ‘active 
ingredient’ means any component that is intended to 
furnish pharmacological activity or other direct ef-
fect in the diagnosis, cure, mitigation, treatment, or 
prevention of disease, or to affect the structure or 
function of the body of humans or animals. The 
term includes components that may undergo chem-
ical change in the manufacture of a drug and may 
be present in a drug in a modified form intended to 
furnish the specified activity or effect. 
‘‘(2) SUNSCREEN
ACTIVE
INGREDIENT.—The 
term ‘sunscreen active ingredient’ means an active 
ingredient that absorbs, reflects, or scatters radi-
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ation in the ultraviolet range at wavelengths from 
290 to 400 nanometers. 
‘‘(3) SUNSCREEN CONDITION.—The term ‘sun-
screen condition’ means a sunscreen active ingre-
dient (or a combination of sunscreen active ingredi-
ents), dosage form, dosage strength, or route of ad-
ministration, marketed for a specific nonprescription 
use. 
‘‘(c) CRITERIA FOR ELIGIBILITY.—To be eligible for 
review under this section, a sunscreen condition shall— 
‘‘(1) not be included in the stayed sunscreen 
monograph; and 
‘‘(2) have been marketed as a nonprescription 
sunscreen condition in the United States or at least 
1 other country, or marketed as a cosmetic or die-
tary supplement in 1 or more counties other than 
the United States— 
‘‘(A) for a minimum of 5 continuous years; 
and 
‘‘(B) in sufficient quantity, as determined 
by the Secretary based upon the information 
submitted under subparagraphs (D) and (E) of 
subsection (d)(1) and, if applicable, subsection 
(d)(2)(A)(ii). 
‘‘(d) APPLICATION FOR ELIGIBILITY.— 
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‘‘(1) IN GENERAL.—A sponsor of a nonprescrip-
tion sunscreen condition described in subsection (c) 
desiring to market such condition in the United 
States may submit an application to the Secretary, 
in such manner and containing such information as 
required by the Secretary, including the following: 
‘‘(A) Basic information about the sun-
screen condition (including a description of each 
active ingredient, pharmacologic class, intended 
nonprescription use, nonprescription strength 
and dosage form, route of administration, and 
directions for use). 
‘‘(B) A detailed chemical description of the 
sunscreen active ingredient that includes a full 
description of the drug substance, including its 
physical and chemical characteristics, the meth-
od of synthesis (or isolation) and purification of 
the drug substance, and any specifications and 
analytical methods necessary to ensure the 
identity, strength, quality, and purity of the 
drug substance, including reference to the cur-
rent edition of the official National Formulary, 
the United States Pharmacopeia, or foreign 
compendiums, where applicable. 
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‘‘(C) A list of each country in which the 
sunscreen condition has been marketed. 
‘‘(D) The cumulative total number of dos-
age units sold for each dosage form of the sun-
screen condition, including total weight of the 
active ingredient, package size for each dosage 
form in which the condition is marketed as non-
prescription, and an estimate of the minimum 
number of potential consumer exposures to the 
condition. 
‘‘(E) The use pattern (according to the 
label) for each country in which the sunscreen 
condition is marketed and any changes in use 
pattern that have occurred over time. 
‘‘(F) A list of all countries in which the 
sunscreen condition has been withdrawn from 
marketing or in which an application for non-
prescription marketing approval has been de-
nied and an explanation for such withdrawal or 
application denial. 
‘‘(2) SUNSCREEN CONDITIONS THAT HAVE NOT 
BEEN MARKETED IN THE UNITED STATES FOR 5 
CONTINUOUS YEARS.— 
‘‘(A) IN GENERAL.—In the case of an ap-
plication with respect to a nonprescription sun-
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screen condition that has not been marketed in 
the United States for 5 continuous years, in ad-
dition to the information required under para-
graph (1), the sponsor shall submit the fol-
lowing information for each country in which 
the sunscreen condition has been marketed: 
‘‘(i) The manner in which the sun-
screen condition has been marketed to con-
sumers. If the sunscreen condition is mar-
keted to consumers as a nonprescription 
pharmacy only condition, the Secretary 
may require supplemental information. 
‘‘(ii) A description of the population 
demographics and the source from which 
this information has been compiled, to en-
sure that the sunscreen condition’s use can 
be reasonably extrapolated to the popu-
lation of the United States. 
‘‘(iii) A description of the country’s 
system for identifying adverse drug experi-
ences, especially those found in non-
prescription marketing experience, includ-
ing method of collection if applicable. 
‘‘(iv) A statement of how long the 
sunscreen condition has been marketed in 
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each country and how long the current 
product labeling has been in use, accom-
panied by a copy of the current product la-
beling, including a translation into English 
of any labeling that is not in English, and 
a statement of whether the current product 
labeling has been authorized, accepted, or 
approved by a regulatory body in each 
country where the condition is marketed. 
‘‘(v) A list of all countries where the 
sunscreen condition is marketed as a pre-
scription drug only and an explanation for 
such restriction. 
‘‘(B) SUNSCREEN CONDITIONS THAT HAVE 
BEEN
MARKETED
IN
MORE
THAN
COUN-
TRIES.— 
‘‘(i) IN GENERAL.—In the case of a 
sunscreen condition that has been mar-
keted as a nonprescription sunscreen in 
more than 5 countries, with a minimum of 
5 continuous years of marketing in at least 
one such country, the sponsor— 
‘‘(I) may submit information in 
accordance with clauses (i) through 
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(iv) of subparagraph (A) with respect 
to only 5 such countries, including— 
‘‘(aa) the country with a 
minimum of 5 continuous years 
of nonprescription marketing; 
‘‘(bb) the country with the 
longest duration of marketing; 
and 
‘‘(cc) the country with the 
most support for marketing, such 
as a large volume of sales with 
cultural diversity among users of 
the product; and 
‘‘(II) shall explain the basis for 
the countries selected under subclause 
(I); and 
‘‘(III) shall provide information 
from more than 5 countries if such in-
formation is needed to support the ap-
plication. 
‘‘(ii) REQUIREMENT.—If the sun-
screen condition meets the criteria under 
items (aa) through (cc) of clause (i)(I) in 
1 or more countries listed in section 
802(b)(1)(A), at least 1 such country shall 
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be included among the 5 countries selected 
under such clause (i)(I). 
‘‘(3) PENDING
APPLICATIONS.—The require-
ments of this subsection shall not apply to a sun-
screen condition deemed eligible for review of safety 
and effectiveness by publication of a notice of eligi-
bility in the Federal Register prior to the date of en-
actment of the Sunscreen Innovation Act. Applica-
tions for such sunscreen conditions shall be consid-
ered in accordance with subsection (g). 
‘‘(e) PUBLIC AVAILABILITY.—If a condition is found 
eligible under subsection (d), the Secretary shall make the 
application publicly available, with redactions for confiden-
tial commercial information or trade secret information, 
and any other information exempt from disclosure pursu-
ant to section 1905 of title 18, United States Code, section 
552(b) of title 5, United States Code, or section 301(j) 
of this Act. Applications shall remain confidential during 
the Secretary’s consideration of eligibility. 
‘‘(f) NEW SUNSCREEN CONDITION APPLICATION.— 
‘‘(1) ELIGIBILITY DETERMINATION.—Not later 
than 60 days after the submission of an eligibility 
application under subsection (d), the Secretary shall 
determine if the sunscreen condition is eligible for 
further review for safety and effectiveness. In the 
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title 18, United States Code, section 552(b) of 
title 5, United States Code, or section 301(j) of 
this Act. 
‘‘(3) NEW SUNSCREEN CONDITION APPLICATION 
SUBMISSION TO THE ADVISORY COMMITTEE.—Not 
later than 30 days after the end of the public com-
ment period described in paragraph (2), the Sec-
retary shall submit the application and the safety 
and effectiveness data submitted under paragraph 
(2) to the Nonprescription Drugs Advisory Com-
mittee (referred to in this section as the ‘advisory 
committee’) for review. 
‘‘(g) PENDING SUNSCREEN CONDITION APPLICA-
TIONS.—Not later than 30 days after the date of enact-
ment of the Sunscreen Innovation Act, the Secretary shall 
submit to the advisory committee all safety and effective-
ness data submitted with respect to each application for 
review of sunscreen conditions that the Secretary had de-
termined, prior to the date of enactment of the Sunscreen 
Innovation Act, to be eligible for review of safety and ef-
fectiveness and for which the information required under 
subsection (f)(2) has been submitted to the Secretary prior 
to such date of enactment. 
‘‘(h) REVIEW
AND RECOMMENDATION
FOR NON-
PRESCRIPTION SUNSCREEN CONDITION.— 
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