There Goes the Sun(screen): FDA Removes PABA and Trolamine Salicylate From OTC Monograph

If a new administrative order on sunscreen sounds familiar, there’s a reason: Less than three months prior, the FDA issued a final administrative order to add a new active ingredient (bemotrizinol) for sunscreen — the first new sunscreen active in more than two decades. After the administrative order adding bemotrizinol, which we covered here, the FDA had permitted a total of 17 active ingredients for sunscreen products. Now with this latest action, we are back down to only 15.

As we have previously explained, sunscreens are regulated in the United States as over-the-counter (OTC) drugs and must comply with the deemed final order for Sunscreen Drug Products for OTC Human Use (M020) unless approved by the FDA under a marketing application (e.g., a New Drug Application). Sunscreen products marketed with cosmetic claims (e.g., claims to beautify, alter appearance, moisturize, etc.) are treated as combination drug-cosmetic products and must meet both OTC drug and cosmetic requirements. 

M020 establishes the conditions under which sunscreen products are generally recognized as safe and effective (i.e., GRASE, and therefore able to be marketed without FDA premarket approval or review), including permissible active ingredients (and combinations of active ingredients), labeling requirements (e.g., directions, water-resistance statements, warnings, and required or prohibited claims), and SPF/broad-spectrum testing procedures. 

As noted above, this latest action is the first final order issued under the FDA’s proposed order (OTC000008) published in September 2021, which proposed broader amendments to the sunscreen monograph. The FDA will address its remaining proposals — including those addressing maximum SPF levels, broad spectrum requirements, dosage forms, labeling, and the GRASE status of 12 other sunscreen active ingredients — in future orders.

The Final Order

Per the September 11 final order, the FDA concluded — based on its scientific review and the public comment record — that there are no conditions under which sunscreen products containing PABA or trolamine salicylate are GRASE. The FDA explained the safety concerns underlying this determination as follows. 

• PABA: Topical use of PABA is associated with significant rates of allergic and photoallergic skin reactions, including severe cases. PABA also poses a cross-sensitization risk: exposure to PABA can cause individuals to develop sensitivity reactions to structurally similar substances, including sulfonamide antibiotics, thiazide diuretics, certain local anesthetics (e.g., benzocaine and procaine), and common dyes. In addition, PABA penetrates the skin and enters systemic circulation, raising further safety concerns. 

• Trolamine Salicylate: Due to its anticoagulant properties, trolamine salicylate may increase the risk of bleeding. Other potential adverse effects associated with salicylic acid exposure include gastrointestinal distress and hemorrhage, ototoxicity, hypersensitivity reactions, asthma exacerbations, liver injury, Reye’s Syndrome (in children), and acute salicylate toxicity. The directed reapplication of sunscreen every two hours significantly increases the potential for transdermal absorption and systemic availability of salicylic acid.

Under the new administrative order, and effective September 11, 2027, such products will be classified as “new drugs” under section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and will require an approved new drug application under section 505 of the FD&C Act in order to be lawfully marketed. 

Practical Implications for Industry

The FDA stated that it is not aware of any sunscreen drug products currently marketed in the United States that contain PABA or trolamine salicylate, so the market impact of the final order should be limited. Nonetheless, companies marketing sunscreen products should take note of several considerations.

• Formulation and Labeling Compliance: Legacy formulations containing PABA or trolamine salicylate as active ingredients need to be reformulated or withdrawn from the market before September 11, 2027, or the manufacturer would need to obtain an approved new drug application. Given the FDA’s safety concerns noted above, any company seeking such approval has a steep uphill battle ahead of them. 

• Remaining Monograph Revisions Are Still Pending: The final order addresses only two of the many proposed changes in OTC000008. The FDA has yet to finalize its proposals regarding maximum SPF levels, broad spectrum requirements, dosage form limitations, labeling updates, final formulation testing and recordkeeping, and combinations of sunscreens with insect repellents. The GRASE status of 12 additional sunscreen active ingredients — including oxybenzone, avobenzone, octinoxate, and homosalate — also remains unresolved. 

• Broader OTC Monograph Reform Trend: The final order reflects the FDA’s continued use of the streamlined administrative order process established by the 2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act) for OTC monograph reform, which enables faster finalization of GRASE determinations compared to the prior rulemaking process.

We will continue to monitor developments regarding the sunscreen OTC monograph, including any future orders issued by the FDA addressing the remaining proposals in the September 2021 proposed order. If you are interested in learning more about FDA regulation of sunscreen products, or are seeking guidance on any of the above, please contact the authors.