FDA removes outdated UV filters following Bemotrizinol approval 

USA – The US Food and Drug Administration (FDA) is eliminating aminobenzoic acid (PABA) and trolamine salicylate from its over-the-counter (OTC) sunscreen monograph, following the agency’s recent addition of bemotrizinol (BEMT) as a permitted sunscreen active ingredient.

This move forms part of a broader modernization of the US sunscreen regulatory framework. 

On September 10, 2026, the FDA issued a final administrative order amending the OTC monograph, formally removing PABA and trolamine salicylate from the list of sunscreen active ingredients and determining that sunscreen products containing these two ingredients as actives are not generally recognized as safe and effective (GRASE). 

The decision reflects the FDA’s wider reassessment of sunscreen actives originally reviewed decades ago, incorporating updated scientific evidence and modern safety evaluations, and the order takes effect on September 11, 2027, unless it is disputed through the applicable statutory process. 

After the effective date, the ingredients can no longer be used as permitted active sunscreen ingredients under the OTC monograph pathway, and any sunscreen products using them as actives may be marketed only after a new drug application has been approved.

Following the addition of BEMT in June and the removal of PABA and trolamine salicylate, the sunscreen OTC monograph now covers 15 active ingredients. 

While the two removed UV filters are no longer commonly used in US sunscreen formulations, the FDA and other organizations have raised safety concerns, and the FDA underscored that no sunscreen products containing PABA or trolamine salicylate were found in the US market at this time. 

The FDA initially proposed removing PABA and trolamine salicylate from the sunscreen OTC monograph in 2021, and its review identified safety concerns associated with PABA, including reports of contact dermatitis and photoallergic reactions, alongside concerns related to repeated sunscreen exposure. 

The agency reached this conclusion based on its review of the scientific literature, data 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, but its use declined due to issues including allergic contact dermatitis, photosensitivity reactions, staining of clothing, and formulation limitations, according to The Campaign for Safe Cosmetics.

Trolamine salicylate is another older UVB filter, and, as with PABA, the FDA found that the risks of using it as a sunscreen active outweigh its benefits. “Trolamine salicylate 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,” says CIRS Group. 

According to CIRS Group, if trolamine salicylate is used in SPF formulations and applied according to the labeled directions for use in sunscreen products, the total amount of salicylic acid absorbed through the skin is considerable. 

As the FDA has stated that no sunscreen products containing the two ingredients are currently marketed in the US, the amendment primarily formalizes their removal from the OTC monograph and provides regulatory clarity.

The FDA’s BEMT approval in June made waves across US sunscreen formulations as the first permitted sunscreen active after two decades of inaction, with the US beauty industry having pushed for approval of a new sunscreen active since the FDA’s last accepted ingredient in the late 1990s. 

The ingredient has been marketed as a sunscreen ingredient in many countries globally for years and can now be used in sunscreens in the US.

BEMT’s US FDA approval is a well-received development by the industry, as the UV filter offers a range of benefits, allowing the replacement of multiple ingredients with one molecule, increasing effective UVA and UVB protection, enhancing photostability, and minimizing bloodstream absorption because of its larger size. 

BEMT’s US approval was inaugurated alongside the green lighting of dsm-firmenich’s BEMT ingredient Parsol Shield, and BASF followed soon after with its own BEMT ingredient marketed as Tinosorb S, which launched in the US under a supplemental license agreement with dsm-firmenich’s subsidiary, DSM Nutritional Products. 

Australian sun care brand Ultra Violette became the first brand in the US to launch a sunscreen containing BEMT, with other brands following suit, and Neutrogena similarly launched Cloud-Tech, a sunscreen technology featuring BEMT for the US market.

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