FDA Axes PABA from Your Sunscreen for Good
Published Date: 9/11/2026
Notice
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).
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Makers: PABA/Trolamine Sunscreens Not GRASE
If you make or sell over-the-counter sunscreen drug products that contain PABA or trolamine salicylate, FDA's final order (available September 11, 2026) amends OTC Monograph M020 to remove those two active ingredients and states such products are not generally recognized as safe and effective. FDA finalized this determination after considering comments on the proposed order from 2021.
PABA and Trolamine Removed from Sunscreens
If you use sunscreen that contains aminobenzoic acid (PABA) or trolamine salicylate, FDA's final order published September 11, 2026 says those ingredients are no longer considered generally recognized as safe and effective (GRASE) for OTC sunscreens. FDA determined the risks of these ingredients in sunscreen drug products outweigh their benefits.
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