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🇺🇸 US FDA removes PABA and trolamine salicylate from sunscreen monograph M020

11 Sep 2027 · United States · Confidence: Secondary (authoritative)

347 days left
01

What happens

The US Food and Drug Administration (FDA) issued Final Order OTC000008-1 on 10–11 September 2026, removing aminobenzoic acid (PABA) and trolamine salicylate from sunscreen monograph M020. FDA states that no products currently marketed in the US contain these two ingredients, so the practical impact is limited; however, it is the first time FDA has formally removed previously permitted sunscreen active ingredients, which is a significant signal.

02

What to do

Companies with US sunscreen lines should watch for further reviews of other active ingredients.

03

Source

FDA Final Order OTC000008-1

Reviewed 22 Sep · Intelligence only, not legal advice — confirm with the competent authority before shipping or signing.

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