[Federal Register Volume 91, Number 111 (Wednesday, June 10, 2026)]
[Notices]
[Pages 35220-35221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2026-11578]
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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, and Related Information
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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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 final administrative order
(final order) (OTC000039) titled ``Amending Over-the-Counter Monograph
M020: Sunscreen Drug Products for Over-the-Counter Human Use, and
Related Information.'' This final order amends ``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 is generally recognized as safe and effective
(GRASE) if it meets the conditions described in OTC Monograph M020 as
amended by this final order.
DATES: The announcement of the availability on FDA's website of the
final order is published in the Federal Register on June 10, 2026.
ADDRESSES: For access to final order OTC000039, go to the OTC
Monographs@FDA portal at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. 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,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is issuing final order OTC000039 to amend the requirements for
sunscreen drug products for OTC human use, as described in OTC
Monograph M020, to add bemotrizinol for use as a sunscreen active
ingredient at concentrations up to 6 percent. 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 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.
Final order OTC000039 amends the conditions described in OTC
Monograph M020, as set forth in final order OTC000006, to add
bemotrizinol at concentrations up to 6 percent as a sunscreen active
ingredient. The final
[[Page 35221]]
order establishes that for a sunscreen drug product containing
bemotrizinol as a sunscreen active ingredient to be legally marketed
without an approved application under section 505 of the FD&C Act (21
U.S.C. 355), among other requirements, it must conform to certain
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
final order permits sunscreen drug products containing bemotrizinol to
be in the following dosage forms: oil, lotion, cream, gel, butter,
paste, ointment, stick, and spray, provided that the sunscreen drug
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.
Final order OTC000039 also includes minor stylistic and formatting
changes to improve the readability, clarity, and presentation of OTC
Monograph M020.
A notice of availability of the proposed order titled ``Amending
Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-
Counter Human Use'' was announced in the Federal Register on December
12, 2025 (90 FR 57765). FDA considered timely submitted comments on the
proposal to amend OTC Monograph M020 to add bemotrizinol as a sunscreen
active ingredient. After considering comments, FDA did not make changes
to the final order.
II. Paperwork Reduction Act of 1995
Final 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.
III. Electronic Access
The final order can be accessed on the OTC Monographs@FDA portal at
https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm. 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. 2026-11578 Filed 6-9-26; 8:45 am]
BILLING CODE 4164-01-P