Notice2025-22649
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 12, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
In response to an over-the-counter (OTC) monograph order request (OMOR), the Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000039) entitled "Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use." This proposed order, if finalized, will amend Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) to add bemotrizinol at concentrations up to 6 percent as a sunscreen active ingredient. A sunscreen drug product containing bemotrizinol would be generally recognized as safe and effective (GRASE) if it meets the conditions described in OTC Monograph M020 as amended by this proposed order, if finalized.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 237 (Friday, December 12, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 237 (Friday, December 12, 2025)]
[Notices]
[Pages 57765-57766]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22649]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-6494]
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products
for Over-the-Counter Human Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: In response to an over-the-counter (OTC) monograph order
request (OMOR), the Food and Drug Administration (FDA) is announcing
the availability on its website of the proposed administrative order
(proposed order) (OTC000039) entitled ``Amending Over-the-Counter
Monograph M020: Sunscreen Drug Products for Over-the-Counter Human
Use.'' This proposed order, if finalized, will amend Over-the-Counter
Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use
(OTC Monograph M020) to add bemotrizinol at concentrations up to 6
percent as a sunscreen active ingredient. A sunscreen drug product
containing bemotrizinol would be generally recognized as safe and
effective (GRASE) if it meets the conditions described in OTC Monograph
M020 as amended by this proposed order, if finalized.
DATES: Submit electronic comments on the proposed order by January 26,
2026.
ADDRESSES: The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system
will accept comments until 11:59 p.m. Eastern Time at the end of
January 26, 2026. Please note that late, untimely filed comments will
not be considered. Instructions for submitting comments are contained
in the proposed order OTC000039, which can be viewed in the OTC
Monographs@FDA portal at <a href="https://www.accessdata.fda.gov/scripts/cder/omuf/">https://www.accessdata.fda.gov/scripts/cder/omuf/</a>. Comments must be submitted electronically.
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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing proposed order OTC000039 to amend OTC Monograph M020
to add bemotrizinol for use as a sunscreen active ingredient at
concentrations up to 6 percent. FDA is issuing the proposed 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 is currently set forth in
Final Administrative Order OTC000006, as deemed by sections 505G(b)(8)
and 505G(k)(2)(B) of the FD&C Act, and was effective upon enactment of
the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-
136) on March 27, 2020. 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.
On September 23, 2024, DSM Nutritional Products LLC submitted a
Tier 1 OMOR requesting FDA issue an administrative order finding that a
sunscreen drug product containing bemotrizinol as an active ingredient
is GRASE under the conditions described in OTC Monograph M020. The
proposed order, if finalized, will amend the conditions described in
OTC Monograph M020, currently set forth in the Final Administrative
Order OTC000006, to add bemotrizinol at concentrations up to 6 percent
as a sunscreen active ingredient. FDA proposes to determine that a
sunscreen drug product containing bemotrizinol as an active ingredient
is GRASE if it meets the conditions described in OTC Monograph M020 as
amended by this proposed order. Among the conditions for drug products
containing bemotrizinol as a sunscreen active ingredient specified by
this proposed order, if finalized, are conditions that address the
concentration of bemotrizinol in the sunscreen drug product, permitted
combinations of bemotrizinol with other sunscreen active ingredients
and with skin protectant active ingredients, and permitted dosage
forms. Specific to dosage forms, the proposed order, if finalized,
would permit the following dosage forms: oil, lotion, cream, gel,
butter, paste, ointment, stick, and spray, provided that the product in
spray dosage form is manufactured and packaged with no propellant or is
manufactured and packaged in a spray delivery system where all
propellant is isolated from the drug product formulation within the
container closure system, and there is no contact between the
propellant and the drug product formulation.
The proposed order can be viewed in the OTC Monographs@FDA portal
at <a href="https://www.accessdata.fda.gov/scripts/cder/omuf/">https://www.accessdata.fda.gov/scripts/cder/omuf/</a>. The proposed
order contains instructions for commenting on the proposed order.
Comments to the proposed order must be submitted electronically to the
Federal eRulemaking Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
OTC Monographs@FDA provides a resource for the public to view
administrative orders (proposed, final, and interim final orders) for
OTC Monograph Drugs and view OTC
[[Page 57766]]
Monographs. In the future, OTC Monographs@FDA will facilitate the
public's ability to submit, search, and view comments and data for
proposed and interim final orders.
II. Paperwork Reduction Act of 1995
The proposed order OTC000039 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 (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 Paperwork Reduction Act of 1995 is not required for
collections of information, if any, in a final order issued under
section 505G that results from this proposed order.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-22649 Filed 12-11-25; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on December 12, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.