Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2025-N-6494] 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 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 A…
Other Federal Register documents from the same docket.
Citation: 91 FR 35220
