case of a sunscreen condition determined to be eligi-
ble, the Secretary shall publish a notice of eligibility 
in the Federal Register, and provide interested per-
sons an opportunity to submit published and unpub-
lished data related to the safety and effectiveness of 
the sunscreen condition for its intended nonprescrip-
tion uses, in accordance with paragraph (2). In the 
case of a sunscreen condition determined not eligi-
ble, the Secretary shall issue a letter to the sponsor, 
which shall be made publicly available. 
‘‘(2) SAFETY AND EFFECTIVENESS DATA SUB-
MISSIONS.— 
‘‘(A) IN GENERAL.—Within 60 days of the 
publication in the Federal Register of an appli-
cation deemed eligible, as described in para-
graph (1), the sponsor and other interested par-
ties shall submit safety and effectiveness data 
to the Secretary for further review, as described 
in subparagraph (B). 
‘‘(B) REQUIRED SUBMISSIONS REGARDING 
DATA.—Submissions under this paragraph shall 
include the following: 
‘‘(i) HUMAN SAFETY DATA.— 
‘‘(I) INDIVIDUAL ACTIVE COMPO-
NENTS.—With respect to individual 
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active components, controlled studies, 
partially controlled or uncontrolled 
studies, documented case reports, per-
tinent marketing experiences that may 
influence a determination as to the 
safety of each individual active compo-
nent, and pertinent medical and sci-
entific literature. 
‘‘(II) COMBINATIONS
OF
INDI-
VIDUAL ACTIVE COMPONENTS.—With 
respect to combinations of the indi-
vidual active components, controlled 
studies, partially controlled or uncon-
trolled studies, documented case re-
ports, pertinent marketing experiences 
that may influence a determination as 
to the safety of combinations of the 
individual active component, and per-
tinent medical and scientific lit-
erature. 
‘‘(ii) EFFICACY DATA.— 
‘‘(I) INDIVIDUAL ACTIVE COMPO-
NENTS.—With respect to individual 
active components, controlled studies, 
partially controlled or uncontrolled 
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studies, documented case reports, per-
tinent marketing experiences that may 
influence a determination on the effi-
cacy of each individual active compo-
nent, pertinent medical and scientific 
literature. 
‘‘(II) COMBINATIONS
OF
INDI-
VIDUAL ACTIVE COMPONENTS.—With 
respect to combinations of the indi-
vidual active components, controlled 
studies, partially controlled or uncon-
trolled studies, documented case re-
ports, pertinent marketing experiences 
that may influence a determination on 
the efficacy of combinations of the in-
dividual active components, and perti-
nent medical and scientific literature. 
‘‘(iii) DATA SETTING FORTH MEDICAL 
RATIONALE AND PURPOSE.—A summary of 
the data and views setting forth the med-
ical rationale and purpose (or lack thereof) 
for the sunscreen condition and the sci-
entific basis (or lack thereof) for the con-
clusion that the condition has been proven 
safe and effective for the intended use. If 
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there is an absence of controlled studies in 
the material submitted, an explanation as 
to why such studies are not considered 
necessary must be included. 
‘‘(iv) OFFICIAL DRUG MONOGRAPH.— 
An applicable United States Pharma-
copoeia or National Formulary for the sun-
screen active ingredient or a proposed 
standard for inclusion in an article to be 
recognized in an official drug monograph 
for the active ingredient, including infor-
mation showing that the official or pro-
posed compendial monograph for the active 
ingredient is consistent with the active in-
gredient used in the studies establishing 
safety and effectiveness and with the active 
ingredient marketed in the nonprescription 
product to a material extent and for a ma-
terial time. If differences exist between the 
official or proposed compendial monograph 
for the active ingredient and the active in-
gredient that is the subject of the applica-
tion, sponsor shall explain such differences. 
‘‘(v) ADVERSE DRUG EXPERIENCES.— 
A list of all serious adverse drug experi-
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ences, as defined by the Secretary, from 
each country where the condition has been 
or is currently marketed as a prescription 
drug or as a nonprescription drug or prod-
uct. 
‘‘(C) OPTIONAL ANIMAL SAFETY DATA.— 
In addition to the information required under 
subparagraph (B), the sponsor may submit in-
formation with respect to animal safety data, 
including controlled studies and partially con-
trolled or uncontrolled studies, in the case of an 
application for individual active components, 
and controlled studies and partially controlled 
or uncontrolled studies in the case of an appli-
cation for combinations of individual active 
components. 
‘‘(D) 
CONFIDENTIALITY
OF
SUBMIS-
SIONS.—The Secretary shall make data and in-
formation submitted by the sponsor, or pursu-
ant to a notice requesting safety and effective-
ness data published in the Federal Register, 
publicly available, with redactions for confiden-
tial commercial information or trade secret in-
formation, and any other information exempt 
from disclosure pursuant to section 1905 of 
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