OTC Sunscreen Monograph Update Archives - Focal Point https://focalpointresearch.net/category/fda/otc-sunscreen-monograph-update/ Scientific, Regulatory and New Product Consultants Tue, 13 Oct 2026 14:12:07 +0000 en-US hourly 1 https://wordpress.org/?v=7.1.3 https://focalpointresearch.net/wp-content/uploads/2021/11/cropped-focal_point_chart_03-32x32.jpg OTC Sunscreen Monograph Update Archives - Focal Point https://focalpointresearch.net/category/fda/otc-sunscreen-monograph-update/ 32 32 126679100 OTC Sunscreen Monograph Update: FDA Finalizes Removal of PABA and Trolamine Salicylate https://focalpointresearch.net/fda/otc-sunscreen-monograph-update-fda-finalizes-removal-of-paba-and-trolamine-salicylate/ Tue, 13 Oct 2026 14:12:02 +0000 https://focalpointresearch.net/?p=6011 The U.S. Food and Drug Administration (FDA) has released a final administrative order officially delisting two active ingredients: aminobenzoic acid (PABA) and trolamine salicylate from the over-the-counter (OTC) sunscreen monograph. Following its regulatory evaluation, the agency concluded that the risks linked to formulating sunscreen drug products with either of these substances outweigh their benefits. Commercial […]

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]]> The U.S. Food and Drug Administration (FDA) has released a final administrative order officially delisting two active ingredients: aminobenzoic acid (PABA) and trolamine salicylate from the over-the-counter (OTC) sunscreen monograph. Following its regulatory evaluation, the agency concluded that the risks linked to formulating sunscreen drug products with either of these substances outweigh their benefits.

Commercial and Consumer Impact:

While this administrative action formally alters the permissible ingredient list for nonprescription sunscreens, its practical disruption to the current retail landscape is minimal:

  • Once the final order takes effect, any sunscreen drug formulation incorporating PABA or trolamine salicylate will require formal FDA approval prior to being sold.
  • The regulatory change is not anticipated to impact products currently available on store shelves, as the agency has found no evidence that any sunscreens presently sold in the United States contain either ingredient.
  • Because existing U.S. formulations do not utilize these substances, no action is required from consumers, whom the FDA encourages to maintain regular sunscreen application alongside broader sun-protective habits to mitigate sun exposure risks.

Regulatory Context and Phased Modernization Under the CARES Act:

This final order represents a key step in the FDA’s broader initiative to overhaul OTC sunscreen monograph requirements utilizing the modernized review framework established by the CARES Act of 2020. After publishing its initial proposed order in September 2021, the regulator received more than 15,000 public comments.

Because of the sheer volume and complexity of stakeholder feedback, the agency opted to advance public health priorities by finalizing the 2021 proposal in stages. Consequently, this initial final order specifically executes two targeted proposals by eliminating both PABA and trolamine salicylate from the OTC sunscreen monograph’s permitted active ingredients list. Meanwhile, the FDA continues to evaluate public comments covering the remaining provisions of the 2021 proposed order, which encompass product dosage forms, SPF levels, and labeling standards.

If you have any questions regarding this update or would like a comprehensive sunscreen formulation/ label review, our team is here to help.

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