FDA Removes PABA and Trolamine Salicylate from OTC Sunscreen Monograph in September 2026 Final Order

Manufacturers still marketing sunscreen formulations under OTC Monograph M020 face a narrowed active ingredient list following FDA's September 10, 2026 final administrative order (OTC000008–1), which formally removes aminobenzoic acid (PABA) and trolamine salicylate on the basis that their risk-benefit profiles no longer support inclusion in OTC sunscreen drug products.

FDA's review of available safety data determined that risks associated with both ingredients outweigh their benefits. The agency notes it is not aware of any currently marketed U.S. sunscreen products containing either ingredient, which limits immediate supply disruption. For QA and regulatory affairs teams, however, the order establishes a compliance baseline: any formulation carrying PABA or trolamine salicylate as a declared active ingredient is now outside monograph coverage and would require a separate approval pathway.

The order is one of several incremental actions taken under the CARES Act framework since 2020. A June 2026 order (OTC000039) had already added bemotrizinol as a permitted active ingredient, and the September 2021 proposed order (OTC000008) drew more than 15,000 public comments, many requiring substantive scientific review before FDA can finalize remaining provisions. Those open items, maximum SPF levels, dosage forms, and labeling requirements, remain unresolved and will be addressed in future orders.

For regulatory affairs leads tracking the 21 CFR Part 352 lineage now consolidated into the monograph system, the phased approach signals that label and dosage-form compliance obligations are still in flux. Teams managing product portfolios with SPF claims above current thresholds or novel delivery formats should treat the outstanding provisions as active regulatory risk, not deferred items.

The agency's decision to finalize the PABA and trolamine salicylate provisions separately, rather than wait for resolution of the full 2021 proposed order, reflects a deliberate sequencing strategy under the CARES Act's administrative order process, one that plant heads and QA directors should factor into their monograph compliance roadmaps as additional final orders are anticipated.

Resolution of the remaining OTC000008 provisions, including maximum SPF labeling and dosage form eligibility, will set the next hard compliance checkpoint for sunscreen manufacturers operating under the monograph framework.

Source: FDA Drugs RSS Feed via FDA.gov, September 10, 2026.