FDA Updates US Sunscreen Rules With Ingredient Changes
The US Food and Drug Administration is changing the regulatory status of two sunscreen ingredients in the United States. Aminobenzoic acid, also known as PABA, and trolamine salicylate are being removed from the over-the-counter sunscreen monograph. At the same time, bemotrizinol, or BEMT, has been added as a permitted sunscreen active ingredient. These changes mark an update to the ingredients that can be used in US sunscreens under the OTC monograph.
Two sunscreen ingredients are being removed
On September 10, 2026, the FDA issued a final administrative order amending the OTC sunscreen monograph. The order removes PABA and trolamine salicylate from the list of permitted sunscreen active ingredients.
The FDA determined that sunscreen products containing either ingredient are not generally recognized as safe and effective, known as GRASE.
The decision follows a broader review of sunscreen active ingredients that were originally assessed decades ago. Updated scientific evidence and modern safety evaluations were considered as part of this review.
The change is scheduled to take effect on September 11, 2027, unless it is disputed through the applicable statutory process.
After that date, PABA and trolamine salicylate will no longer be permitted as active sunscreen ingredients under the OTC monograph pathway. Products using either ingredient as a sunscreen active will require approval through a new drug application.
With BEMT added in June and the two ingredients removed, the US sunscreen OTC monograph now covers 15 active ingredients.
Why PABA and trolamine salicylate are being removed
PABA and trolamine salicylate are no longer commonly used in US sunscreen formulations. The FDA and other organizations have raised safety concerns about both ingredients.
The FDA stated that no sunscreen products containing PABA or trolamine salicylate were found on the US market at the time of its decision.
The FDA first proposed removing the two ingredients from the sunscreen OTC monograph in 2021. Its review identified safety concerns associated with PABA, including reports of contact dermatitis and photoallergic reactions. Concerns were raised about repeated exposure to sunscreen containing the ingredient as well.
The FDA considered scientific literature, information from the FDA Adverse Event Reporting System, and review documents from the FDA and the European Medicines Agency.
PABA was one of the first widely used UVB filters. Its use later declined amid concerns including allergic contact dermatitis, photosensitivity reactions, staining of clothing, and formulation limitations.
Trolamine salicylate is another older UVB filter. The FDA determined that the risks associated with its use as a sunscreen active outweigh its benefits.
The ingredient has anticoagulant properties that may increase the risk of bleeding. As a salicylate, it may cause adverse reactions including gastrointestinal distress and bleeding, ototoxicity, hypersensitivity reactions, worsening of asthma symptoms, and acute salicylate toxicity.
The amount of salicylic acid absorbed through the skin is considerable when trolamine salicylate is used in SPF formulations and applied according to the labeled directions for sunscreen products.
Since the FDA found no sunscreen products containing either ingredient currently marketed in the US, the amendment mainly formalizes their removal from the OTC monograph and provides regulatory clarity.
BEMT joins the US sunscreen ingredient list
The regulatory changes come alongside the addition of bemotrizinol, or BEMT, to the US sunscreen framework.
The FDA approved BEMT in June. It was the first permitted sunscreen active approved after two decades of inaction. Before this approval, the US beauty industry had been pushing for a new sunscreen active since the FDA’s last accepted ingredient in the late 1990s.
BEMT has been marketed as a sunscreen ingredient in many countries around the world for years. It can now be used in sunscreens in the US.
The ingredient offers several potential benefits. These include replacing multiple ingredients with one molecule, increasing effective UVA and UVB protection, improving photostability, and reducing bloodstream absorption because of its larger size.
The addition of BEMT, together with the removal of PABA and trolamine salicylate, changes the list of active ingredients permitted under the US OTC sunscreen monograph.
