The U.S. Food and Drug Administration (FDA) has introduced an important regulatory change affecting active ingredients used in sunscreen products.
Under Final Administrative Order OTC000008-1, issued on 11 September 2026, the FDA removed aminobenzoic acid (PABA) and trolamine salicylate from the active ingredients permitted under OTC Monograph M020 for sunscreen drug products.
Following its scientific review of the available safety data, the FDA concluded that sunscreen drug products containing PABA or trolamine salicylate no longer meet the conditions required to be considered Generally Recognized as Safe and Effective (GRASE).
Unless the final order is subject to a dispute that affects its implementation, the new requirements will become effective on 11 September 2027.
Why Has the FDA Removed PABA from the Sunscreen Monograph?
According to the FDA’s safety assessment, topical use of PABA is associated with significant rates of allergic and photoallergic skin reactions, some of which may be severe.
The FDA also identified concerns regarding cross-sensitisation to structurally similar substances. In addition, available data indicate that PABA can penetrate the skin and enter the systemic circulation, creating further safety concerns.
Based on these findings, the FDA concluded that sunscreen drug products containing PABA should no longer be considered GRASE under the OTC sunscreen monograph.
What Are the Safety Concerns Associated with Trolamine Salicylate?
For trolamine salicylate, the FDA highlighted potential serious adverse effects related to its anticoagulant properties, which may increase the risk of bleeding.
Topical use may also lead to adverse effects associated with salicylic acid exposure. The FDA’s assessment refers to potential risks including gastrointestinal distress and haemorrhage, hypersensitivity reactions, asthma exacerbations, ototoxicity, liver injury and, at higher exposures, acute salicylate toxicity.
The potential for transdermal absorption and systemic exposure to salicylic acid is particularly relevant because sunscreen products may be applied to large areas of exposed skin and reapplied regularly according to product labelling.
What Will Change from 11 September 2027?
Once the final order becomes effective, sunscreen products containing PABA or trolamine salicylate as active sunscreen ingredients will no longer be eligible for marketing under OTC Monograph M020.
Products containing either substance as a sunscreen active ingredient will instead be considered new drugs under the Federal Food, Drug, and Cosmetic Act and will be subject to the requirement for an approved New Drug Application (NDA) before they can be legally marketed in the United States.
What Does the FDA Decision Mean for Companies Exporting Sunscreens to the U.S.?
The FDA states that it is not aware of any sunscreen drug products containing PABA or trolamine salicylate currently being marketed in the United States.
Nevertheless, companies manufacturing or exporting sunscreen products for the U.S. market should use the transition period before September 2027 to review:
- sunscreen formulations,
- active UV filters,
- raw material specifications,
- supplier documentation,
- product dossiers and U.S.-specific formulations.
This can help companies confirm that PABA and trolamine salicylate are not being used as sunscreen active ingredients and identify potential compliance issues before the new requirements take effect.
FDA Continues to Modernise U.S. Sunscreen Regulation
The removal of PABA and trolamine salicylate forms part of the FDA’s broader efforts to update the U.S. regulatory framework for sunscreen products.
In June 2026, the FDA added bemotrizinol at concentrations of up to 6% to OTC Monograph M020. Bemotrizinol became the first new sunscreen active ingredient added to the U.S. OTC sunscreen framework in approximately two decades. (U.S. Food and Drug Administration)
Taken together, the recent decisions show an evolving regulatory framework in which the FDA is evaluating new UV filters while also removing ingredients where the available evidence no longer supports a positive GRASE determination.