Health and Human Services Department, Food and Drug Administration
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).
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-1978-N-0018] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. 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. ( printed page 57893) ADDRESSES: For access to final order OTC000008-1, 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…
Other Federal Register documents from the same docket.
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-The-Counter Human Use; Over-The-Counter Monograph Proposed Order (OTC 000008) Extension of Comment Period
Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use; Over the Counter Monograph Proposed Order; Availability
Sunscreen Drug Products for Over-the-Counter Human Use; Correction
Sunscreen Drug Products for Over-the-Counter Human Use; Extension of Comment Period
Sunscreen Drug Products for Over-the-Counter Human Use
Citation: 91 FR 57892
