On September 11, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000008-1, amending OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (OTC Monograph M020) and formally removing aminobenzoic acid (PABA, CAS No. 150-13-0) and trolamine salicylate (TEA salicylate, CAS No. 2174-16-5) from the Sunscreen Active Ingredients list, determining that sunscreen products containing these two ingredients are not "generally recognized as safe and effective" (GRASE). The order takes effect on September 11, 2027.
After the effective date, sunscreen products using these two substances as sunscreen active ingredients will no longer qualify for the OTC monograph pathway and may be marketed only after a new drug application (NDA) has been approved. (If a stakeholder files a formal objection to the order under section 505G(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the effective date will be determined in accordance with the procedural rules of that provision.)
Regulatory Timeline
The regulatory timeline leading to this final order is as follows:
- On March 27, 2020, following the enactment of the CARES Act, the requirements of the 1999 sunscreen monograph were carried over into OTC Monograph M020; PABA and trolamine salicylate remained on the list of sunscreen active ingredients permitted under M020;
- On September 24, 2021, the U.S. FDA issued Proposed Administrative Order OTC000008, proposing based on its safety evaluation that the use of the two ingredients in sunscreen products poses risks that outweigh their benefits, and proposing to remove them from the monograph list; the public comments received during the comment period all supported the proposal;
- On September 11, 2026, the U.S. FDA issued Final Administrative Order OTC000008-1, formally deleting the two ingredients from OTC Monograph M020, which will take effect on September 11, 2027.
Removal Rationale: Based on Safety Review Conclusions
Aminobenzoic acid (PABA): Based on its review of the scientific literature, data from the FDA Adverse Event Reporting System (FAERS), and review documents from the FDA and the European Medicines Agency, the U.S. FDA concluded that topical application of PABA causes allergic and photoallergic skin reactions at relatively high rates, some of which may reach a severe level. PABA can also induce cross-sensitization to structurally related aromatic amines and nitro compounds, causing sensitization in exposed individuals to substances such as sulfonamide antibiotics, the hair dye component p-phenylenediamine, and aniline dyes. In addition, PABA can penetrate the skin and enter systemic circulation, posing additional safety risks.
Trolamine salicylate: This substance has anticoagulant properties, with the potential to increase the risk of bleeding; as a salicylate, it may also cause a number of adverse reactions, including gastrointestinal distress and bleeding, ototoxicity, hypersensitivity reactions, worsening of asthma symptoms, and acute salicylate toxicity. According to the labeled directions for use—application over the entire skin surface exposed to sunlight and reapplication every 2 hours—the total amount of salicylic acid absorbed through the skin is considerable, and the risk of the above adverse events warrants close attention.
Handling of comments: The public comments received during the comment period all supported the FDA’s proposal, and the FDA accordingly made no changes to the text of the order. The FDA also noted that no sunscreen products containing PABA or trolamine salicylate have been found on the U.S. market at this time.
Regulatory Requirements After the Effective Date
Regulatory status: Once the order takes effect on September 11, 2027, sunscreen products that use PABA or trolamine salicylate as sunscreen active ingredients will be deemed "new drugs" under section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Such products may be marketed only after a new drug application (NDA) has been completed under section 505 of the Act and approved by the FDA, and marketing through the OTC monograph pathway will no longer be permitted. This order does not grant any enterprise a period of market exclusivity.
Note: On June 9, 2026, the U.S. Food and Drug Administration (FDA) issued Final Administrative Order OTC000039, formally including bemotrizinol in OTC Monograph M020: Sunscreen Drug Products for Over‑the‑Counter Human Use (OTC Monograph M020) and approving it for use as a sunscreen active ingredient. With this addition, the number of sunscreen active ingredients listed in the monograph has increased to 17. This final order officially took effect on August 9, 2026.
Monograph text: Aminobenzoic acid (PABA) under paragraph (a) and trolamine salicylate under paragraph (p) are deleted, and the letter designations are rearranged in the sequence (a) through (o). With this revision, the number of sunscreen active ingredients covered by the monograph is reduced from the previous 17 to 15.
Implications and Recommendations for Cosmetic Enterprises
1. Enterprises exporting sunscreen products to the U.S.: The FDA has stated that no sunscreen products containing these two ingredients are currently on the market, so this removal is largely a matter of "closing the final gap". It is advisable to screen export product formulations and raw material supply chains to confirm that they do not contain PABA or trolamine salicylate, and to avoid non-compliance after the order takes effect on September 11, 2027. Enterprises are also reminded that sunscreens in the U.S. are regulated as OTC drugs, which differs from the cosmetic regulation in China; before exporting, enterprises should first confirm whether the product will follow the drug or the cosmetic pathway;
2. Cross-regional regulatory difference management: Note that PABA and trolamine salicylate are restricted in the U.S. OTC sunscreen context, but the control requirements under the cosmetics regulations of other countries/regions are different. Enterprises need to make compliance determinations separately for each target market;
3. Attention to the systemic impact of follow-up orders: Beyond these two ingredients, the 2021 Proposed Administrative Order also involves revisions in multiple areas, such as SPF limits, broad spectrum requirements, dosage forms, labeling, and testing recordkeeping, and the relevant content will be finalized in due course, with a significant impact on sunscreen products exported to the U.S. Enterprises are advised to evaluate the costs of formulation, testing, and label changes in advance and allow sufficient time for adjustments.
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