Opportunity
Federal Register #FDA-1978-N-0018
FDA Final Order: Removal of PABA and Trolamine Salicylate from OTC Sunscreens
Buyer
Food and Drug Administration
Posted
September 11, 2026
Identifier
FDA-1978-N-0018
This notice announces a regulatory action by the Food and Drug Administration (FDA) regarding sunscreen drug products: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Action: - Final administrative order amending Over-the-Counter (OTC) Monograph M020 for sunscreen drug products - Key Details: - Removes aminobenzoic acid (PABA) and trolamine salicylate as active ingredients in OTC sunscreen products - Determination that these ingredients are not generally recognized as safe and effective (GRASE) due to safety concerns - OEMs and Vendors: - No specific OEMs or vendors are mentioned - Products/Services Requested: - No procurement of products or services is requested - No part numbers or quantities provided - Unique Requirements: - Regulatory change affecting the formulation of OTC sunscreen products - Impacts manufacturers using PABA or trolamine salicylate in their products, but does not involve a government purchase or contract
Description
The Food and Drug Administration (FDA) has issued a final administrative order amending Over-the-Counter Monograph M020 to remove aminobenzoic acid (PABA) and trolamine salicylate as active ingredients in sunscreen drug products. These ingredients are no longer recognized as safe and effective (GRASE) due to safety concerns outweighing benefits. The order finalizes previous proposals and is effective as of September 11, 2026. This amendment affects the conditions under which OTC sunscreen products are considered safe for human use.