The U.S. Food and Drug Administration (FDA) has finalized the removal of aminobenzoic acid (PABA) and trolamine salicylate as permitted FDA sunscreen active ingredients under Over-the-Counter (OTC) Monograph M020. Final Administrative Order OTC000008-1, issued on September 11, 2026, will take effect on September 11, 2027. From that date, sunscreen drug products containing either ingredient as an active sunscreen ingredient will no longer qualify for marketing under the OTC monograph and will be subject to the requirement for an approved new drug application (NDA).
For manufacturers, brand owners, formulation developers, and companies planning to market sunscreen products in the United States, the change creates a clear timeline for reviewing affected formulations and U.S. market pathways.
What Has Changed Under the OTC Sunscreen Monograph?
FDA's final order amends Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use by removing:
Aminobenzoic Acid (PABA) — CAS No. 150-13-0
Trolamine Salicylate — CAS No. 2174-16-5
FDA determined that sunscreen drug products containing these active ingredients are not generally recognized as safe and effective (GRASE) under the applicable conditions of use.
According to FDA, the available evidence does not support the continued GRASE status of either ingredient as a sunscreen active ingredient. FDA identified safety concerns related to PABA, including sensitization and systemic absorption, and concerns associated with trolamine salicylate and systemic salicylate exposure.
FDA has also stated that it is not aware of any sunscreen drug products currently marketed in the United States containing PABA or trolamine salicylate. The immediate impact on products already sold in the U.S. may therefore be limited, but the change remains relevant to legacy formulations, global product portfolios, and products being developed for future U.S. market entry.
Companies seeking a broader understanding of how sunscreens and other borderline products are regulated in the United States can refer to REACH24H's U.S. FDA OTC and Cosmetic Regulations guide.
FDA's Review of Sunscreen Regulations Is Still Ongoing
The latest order finalizes only the PABA and trolamine salicylate provisions of FDA's 2021 Proposed Administrative Order OTC000008.
Other proposed matters—including the GRASE status of other sunscreen active ingredients, maximum labeled SPF values, broad-spectrum requirements, dosage forms, labeling, final formulation testing, and recordkeeping—have not been finalized through this order. FDA has indicated that these matters will be addressed in future administrative orders, as appropriate.
This means companies should distinguish between requirements already in effect and provisions that remain proposed when assessing FDA sunscreen compliance.
For additional context on recent U.S. cosmetic and sunscreen regulatory developments, see REACH24H's 2026 North American Cosmetic Regulatory Outlook.
What Should Sunscreen Companies Do?
Companies manufacturing, developing, or supplying sunscreen products for the U.S. market should use the period before September 11, 2027 to assess whether the final order affects their products.
Key actions include:
Review U.S.-bound formulations for PABA or trolamine salicylate used as sunscreen active ingredients.
Evaluate reformulation where necessary, including potential implications for testing, documentation, and labeling.
Confirm the appropriate U.S. regulatory pathway. Products continuing to contain either ingredient as a sunscreen active ingredient after the effective date will no longer qualify for the OTC Monograph M020 pathway and will be subject to the requirement for an approved NDA.
Monitor further FDA sunscreen updates, particularly future orders addressing the remaining provisions of the 2021 proposed order.
For companies using global formulations, compliance in another market should not automatically be taken to mean that the same formulation meets U.S. OTC sunscreen requirements. Ingredient status and the applicable U.S. regulatory pathway should be assessed before launch.
How REACH24H Can Help
REACH24H supports global companies in navigating U.S. sunscreen and OTC drug regulatory requirements, including:
FDA sunscreen active ingredient and formulation review;
OTC Monograph M020 compliance assessment;
U.S. labeling and Drug Facts review;
regulatory gap analysis for products entering the U.S. market;
reformulation-related regulatory assessment; and
ongoing monitoring of FDA regulatory developments.
Companies using PABA or trolamine salicylate, or developing new sunscreen products for the United States, should assess the implications of Final Administrative Order OTC000008-1 ahead of its September 11, 2027 effective date.
