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FDA Issues Final Order Removing PABA and Trolamine Salicylate as Sunscreen Active Ingredients

Today, the U.S. Food and Drug Administration issued a final administrative order removing two active ingredients — aminobenzoic acid (PABA) and trolamine salicylate — from the list of ingredients that can be used in sunscreen drug products under the OTC sunscreen monograph. FDA determined that the risks associated with use of these active ingredients in sunscreen drug products outweigh their benefits.

What This Means

Once the final order is in effect, sunscreen drug products containing PABA or trolamine salicylate can no longer be sold without FDA approval. In practice, this change is not expected to affect the sunscreen drug products currently on store shelves. Consumers do not need to take any action because FDA is not aware of any sunscreens sold in the U.S. today that contain either of these ingredients. Consumers should continue to use sunscreens along with other sun protective measures to reduce risks from sun exposure.

Background

This action is part of FDA's ongoing work to update the requirements in the OTC monograph for sunscreen drug products under a modernized review process established by the CARES Act of 2020. FDA issued the proposed order in September 2021, which received over 15,000 public comments. Given the volume and complexity of comments received, FDA determined it was in the interest of public health to finalize the proposed order in parts. Therefore, FDA is now issuing this first final order addressing two proposals: 1) the removal of PABA and 2) the removal of trolamine salicylate from the list of ingredients that can be used in sunscreen OTC monograph drug products. FDA is continuing to review comments related to remaining provisions of the 2021 proposed order, including topics such as SPF levels, labeling, and product dosage forms.

More Information

• Read the full text of the Final Administrative Order OTC000008 – 1
• Read the Notice of Availability published in the Federal Register
• View information about the regulation of sunscreens
• View information for consumers about sunscreens

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