Notice2026-18551
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate
Primary source
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Published
September 11, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability on its website of the final administrative order (final order) (OTC000008-1) titled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate." This final order amends "Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use" (Over- the-Counter (OTC) Monograph M020) to remove PABA and trolamine salicylate as sunscreen active ingredients. A sunscreen drug product containing PABA or trolamine salicylate is not generally recognized as safe and effective (GRASE).
Full Text
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<title>Federal Register, Volume 91 Issue 175 (Friday, September 11, 2026)</title>
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[Federal Register Volume 91, Number 175 (Friday, September 11, 2026)]
[Notices]
[Pages 57892-57893]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-18551]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1978-N-0018]
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products
for Over-the-Counter Human Use, and Related Information; Aminobenzoic
Acid (PABA) and Trolamine Salicylate
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability on its website of the final administrative order
(final order) (OTC000008-1) titled ``Amending Over-the-Counter
Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use,
and Related Information; Aminobenzoic Acid (PABA) and Trolamine
Salicylate.'' This final order amends ``Over-the-Counter Monograph
M020: Sunscreen Drug Products for Over-the-Counter Human Use'' (Over-
the-Counter (OTC) Monograph M020) to remove PABA and trolamine
salicylate as sunscreen active ingredients. A sunscreen drug product
containing PABA or trolamine salicylate is not generally recognized as
safe and effective (GRASE).
DATES: The announcement of the availability on FDA's website of the
final order is published in the Federal Register on September 11, 2026.
[[Page 57893]]
ADDRESSES: For access to final order OTC000008-1, go to the OTC
Monographs@FDA portal at <a href="https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm">https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm</a>. See the SUPPLEMENTARY INFORMATION section for more
information on electronic access to the final order.
FOR FURTHER INFORMATION CONTACT: Shannon Liu, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-2484,
<a href="/cdn-cgi/l/email-protection#b4e7dcd5dadadbda9af8ddc1f4d2d0d59adcdcc79ad3dbc2"><span class="__cf_email__" data-cfemail="da89b2bbb4b4b5b4f496b3af9abcbebbf4b2b2a9f4bdb5ac">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing final order OTC000008-1 to amend the requirements
for sunscreen drug products for OTC human use, as described in OTC
Monograph M020, to remove PABA and trolamine salicylate as sunscreen
active ingredients. FDA is issuing the final order pursuant to section
505G(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355h(b)(1)).
OTC Monograph M020 describes the conditions under which OTC
sunscreen drug products are GRASE under section 201(p)(1) of the FD&C
Act (21 U.S.C. 321(p)(1)). OTC Monograph M020 was previously set forth
in final order OTC000039, issued on June 10, 2026. The conditions
described in OTC Monograph M020 may be amended, revoked, or otherwise
modified in accordance with the procedures of section 505G(b) of the
FD&C Act.
Final order OTC000008-1 amends the conditions described in OTC
Monograph M020, as set forth in final order OTC000039, to remove PABA
and trolamine salicylate as sunscreen active ingredients. FDA has
determined that there are no conditions under which a drug product
containing PABA or trolamine salicylate as a sunscreen active
ingredient is GRASE under section 201(p)(1) of the FD&C Act because
FDA's review of the available safety data for PABA and trolamine
salicylate shows that the risks associated with use of these active
ingredients in sunscreen drug products outweigh the benefits.
A notice of availability of the proposed order OTC000008 titled
``Amending Over-the-Counter (OTC) Monograph M020: Sunscreen Drug
Products for OTC Human Use'' was announced in the Federal Register on
September 27, 2021 (86 FR 53322) (comment period extended November 22,
2021 (86 FR 66318)). FDA proposed to establish certain new conditions
under which nonprescription sunscreen drug products would be determined
to be GRASE. Relevant to this final order, FDA proposed to amend OTC
Monograph M020 to remove PABA and trolamine salicylate as sunscreen
active ingredients because FDA's review of the available safety data
for PABA and trolamine salicylate shows that the risks associated with
use of these active ingredients in sunscreen drug products outweigh
their benefits. FDA considered timely submitted comments on the
proposal to amend OTC Monograph M020 to remove PABA and trolamine
salicylate as sunscreen active ingredients, and after considering
comments, FDA in this final order OTC000008-1 finalizes its proposed
determinations regarding sunscreen drug products containing PABA and
trolamine salicylate without change. FDA will address the other aspects
of proposed order OTC000008 in a future order or orders.
II. Paperwork Reduction Act of 1995
Final order OTC000008-1 is issued under section 505G(b)(1) of the
FD&C Act. Under section 505G(o) of the FD&C Act, the Paperwork
Reduction Act of 1995 (PRA) (Chapter 35 of title 44, United States
Code) does not apply to collections of information made under section
505G of the FD&C Act. Therefore, clearance by the Office of Management
and Budget under the PRA is not required for collections of
information, if any, in a final order issued under section 505G of the
FD&C Act.
III. Electronic Access
The final order can be accessed on the OTC Monographs@FDA portal at
<a href="https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm">https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm</a>. Under the
``Administrative Orders'' banner, click on the desired link under the
``Order ID'' heading and follow the prompts. FDA established this
information technology system with a web portal that can be accessed
through FDA's website. The OTC Monographs@FDA portal provides a
resource for the public to view administrative orders (proposed, final,
and interim final orders), as well as related supporting documents, for
OTC Monograph Drugs and view OTC Monographs. In the future, the OTC
Monographs@FDA portal will facilitate the public's ability to submit,
search, and view comments and data for proposed and interim final
orders.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-18551 Filed 9-10-26; 8:45 am]
BILLING CODE 4164-01-P
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