The U.S. Food and Drug Administration (FDA) has issued a final administrative order, officially removing aminobenzoic acid (PABA) and trolamine salicylate from the list of approved active ingredients in over-the-counter (OTC) sunscreen products, citing that their potential health risks outweigh their benefits. Once effective, sunscreens containing either ingredient cannot be sold without explicit FDA approval. However, this rule change will not impact current retail availability or consumer habits, as the FDA confirms neither ingredient is present in sunscreens sold in the U.S. today. Established as part of a modernized review process under the 2020 CARES Act, this order is the first portion finalized from a broader Septembre 2021 proposed order that generated over 15,000 public comments. The agency decided to finalize these ingredient removals separately while continuing its review of comments regarding other proposed regulations, such as maximum SPF levels, dosage forms, and product labeling.
More Information
- Read the full text of the Final Administrative Order OTC000008 – 1
- Read the Notice of Availability published in the Federal Register
- View information about the regulation of sunscreens
- View information for consumers about sunscreens
