FDA axes sketchy sunscreen ingredients: PABA and trolamine salicylate out
Published Date: 9/11/2026
Notice
Summary
The FDA just announced that sunscreens with PABA or trolamine salicylate are no longer considered safe and effective, so these ingredients are being removed from the official sunscreen rules. This change affects sunscreen makers and shoppers who want safe sun protection. The update is live as of September 11, 2026, so companies need to adjust their products soon to keep selling them.
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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