USA-FDA Removes Aminobenzoic Acid (PABA) and Trolamine Salicylate from the Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020)

On September 11, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000008-1, amending OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) and formally removing aminobenzoic acid (PABA, CAS No. 150-13-0) and trolamine salicylate (TEA salicylate, CAS No. 2174-16-5) from the Sunscreen Active Ingredients list, determining that sunscreen products containing these two ingredients are not "generally recognized as safe and effective" (GRASE). The order takes effect on September 11, 2027. After the effective date, sunscreen products using these two substances as sunscreen active ingredients will no longer qualify for the OTC monograph pathway and may be marketed only after a new drug application (NDA) has been approved. (If a stakeholder files a formal objection to the order under section 505G(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the effective date will be determined in accordance with the procedural rules of that provision.)