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Product safetyFDAUnited StatesImports

Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate

11 September 2026

In plain English

FDA has issued a final order amending OTC Monograph M020 for sunscreen drug products, addressing aminobenzoic acid (PABA) and trolamine salicylate ingredients.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
11 September 2026
For
Imports
Where it applies
United States

From the notice

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
The full text is at the source

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