FDA Final Order of September 10, 2026, Removing PABA and Trolamine Salicylate from the U.S. OTC Sunscreen Monograph

The U.S. Food and Drug Administration (FDA) has issued a final administrative order removing two active ingredients—aminobenzoic acid (PABA) and trolamine salicylate—from the list of ingredients permitted for use in sunscreen drug products under the U.S. over-the-counter (OTC) sunscreen monograph.

Following its review of the available safety data, FDA determined that the risks associated with the use of PABA and trolamine salicylate in sunscreen drug products outweigh their benefits. FDA has therefore determined that these ingredients are not GRASE (Generally Recognized as Safe and Effective) for use in sunscreens.

What Does This Mean?

The FDA’s action does not represent a recall of sunscreen products currently available in the United States. FDA states that it is not aware of any sunscreen drug products currently sold in the U.S. that contain PABA or trolamine salicylate. The purpose of the action is instead to remove these ingredients from the regulatory pathway that allows certain OTC sunscreen products to be marketed under the sunscreen monograph.

Once the final order becomes effective, sunscreen products containing PABA or trolamine salicylate will no longer be able to rely on the OTC sunscreen monograph for marketing and would require an applicable FDA-approved pathway.

The FDA issued the final order in September 2026. Under the CARES Act, a sunscreen final order cannot become effective earlier than one year after its issuance; the order therefore provides for an effective date in September 2027, subject to the applicable statutory process if the order is disputed.

Consumers do not need to take any specific action as a result of this announcement and should continue using sunscreen along with other sun-protective measures.

How Does the 2026 Final Order Relate to the 2021 Proposed Order?

The 2026 action is part of the FDA’s ongoing work to finalize the broader sunscreen regulatory changes proposed in 2021 under Proposed Administrative Order OTC000008.

In September 2021, FDA proposed changes to the OTC sunscreen monograph and categorized sunscreen active ingredients according to their proposed GRASE status. The proposal was subject to an extensive public-comment process, receiving more than 15,000 comments. Because many of the comments were substantive and required additional scientific review, FDA decided to address the different elements of the proposal in stages.

The 2021 proposal classified the sunscreen active ingredients as follows:

GRASE means Generally Recognized as Safe and Effective under section 201(p)(1) of the Federal Food, Drug, and Cosmetic Act.

What Has FDA Finalized Since the 2021 Proposal?

The 2026 final order specifically finalizes the 2021 proposal concerning PABA and trolamine salicylate. FDA concluded that these two ingredients are not GRASE because of safety concerns and has removed them from the OTC sunscreen monograph. The remaining provisions of the 2021 proposal will be addressed through subsequent FDA action, as appropriate.

Importantly, FDA’s classification of the other 12 ingredients as “not GRASE because additional data are needed” does not mean that FDA determined those ingredients to be unsafe. Rather, FDA requested additional information so that their safety and effectiveness could be evaluated in light of increased sunscreen use and evolving scientific information.

There has also been a separate development in 2026. On June 10, 2026, FDA issued Final Order OTC000039, adding bemotrizinol as a permitted sunscreen active ingredient after reviewing safety and efficacy information submitted through an OTC Monograph Order Request and information from FDA’s literature reviews. FDA concluded that bemotrizinol is GRASE under the conditions specified in the final order.

Should Consumers Only Use Sunscreens Containing Zinc Oxide, Titanium Dioxide, or Bemotrizinol?

No. The 2021 proposed order should not be interpreted as meaning that only these three ingredients are safe for use in sunscreens.

FDA specifically stated that the ingredients for which additional data were requested were not determined to be unsafe. Their GRASE status requires further evaluation based on available and emerging scientific evidence. The addition of bemotrizinol in 2026 represents a separate regulatory decision based on FDA’s review of additional safety and efficacy information.

Sun protection remains important for people of all skin tones. FDA recommends using sunscreen together with other protective measures, such as wearing protective clothing, sunglasses and a hat, and seeking shade when possible during periods of peak sunlight. Broad-spectrum sunscreen with an SPF of at least 15 is one component of a broader sun-protection strategy. People with questions about sunscreen use in infants, children, or during pregnancy should consult a healthcare professional.

What Does This Mean for Other Countries?

The FDA decision applies to the U.S. regulatory system and does not automatically ban PABA or trolamine salicylate in other countries. However, it may serve as relevant foreign regulatory and safety information for authorities in jurisdictions where these ingredients are registered or marketed. Each country’s regulatory authority would independently determine whether any action is required under its own laws and regulations.

For example, in Pakistan, the FDA decision would not automatically change the regulatory status of these ingredients under DRAP. It could, however, be considered as part of a regulatory or pharmacovigilance assessment where relevant products are marketed in Pakistan.

Conclusion

The FDA’s 2026 final order represents the first finalized portion of the broader sunscreen regulatory changes proposed in 2021 under OTC000008. It specifically removes PABA and trolamine salicylate because FDA determined that the risks associated with their use in sunscreens outweigh their benefits.

The action does not represent a recall of currently marketed U.S. sunscreens, as FDA is not aware of any currently marketed U.S. sunscreen products containing these ingredients. Instead, it removes their ability to be marketed under the U.S. OTC sunscreen monograph once the final order becomes effective.

At the same time, the FDA’s 2021 proposal should be viewed as an ongoing regulatory process rather than a determination that all ingredients other than zinc oxide, titanium dioxide, and bemotrizinol are unsafe. FDA continues to evaluate the available evidence for the remaining ingredients and may take further regulatory action as the scientific and regulatory review progresses.