Date:  23 September 2026

Prepared for:  Importers, Manufacturers, Suppliers and Buyers of Sunscreen Products for the US Market

Regulatory Update:  FDA Removes PABA and Trolamine Salicylate from OTC Sunscreen Monograph

On 10 September 2026, the US Food and Drug Administration (FDA) issued Final Administrative Order OTC000008-1, amending Over-the-Counter Monograph M020 for sunscreen drug products. The order removes aminobenzoic acid (PABA; CAS 150-13-0) and trolamine salicylate (CAS 2174-16-5) from the list of permitted sunscreen active ingredients.

Sunscreen products containing either substance are no longer considered generally recognised as safe and effective (GRASE) under section 201(p)(1) of the Federal Food, Drug, and Cosmetic Act.

The order takes effect on 11 September 2027, one year after publication.

Background: Why Sunscreen Is Regulated as an OTC Drug in the US

In the United States, sunscreen products are regulated as over-the-counter (OTC) drug products rather than cosmetics. This differs from the EU and many other markets, where sunscreen products are generally treated as cosmetics. In the US, sunscreen active ingredients must either be recognised as Generally Recognized As Safe and Effective (GRASE) under an applicable OTC monograph.

OTC Monograph M020 describes the conditions under which sunscreen drug products are considered GRASE. Products that fall outside the monograph must go through the new drug approval process.

The FDA Review

The FDA proposed the removal of PABA and trolamine salicylate in September 2021 under Proposed Administrative Order OTC000008.

PABA became a widely used UVB filter since the 1950s. But it was found that PABA was linked to high rates of allergic and photoallergic skin reactions, as well as cross-sensitisation with structurally similar compounds. It is also absorbed through the skin into systemic circulation.

Trolamine salicylate has also been used for decades. But it was found that Trolamine salicylate has anticoagulant properties that may increase bleeding risk. It is also absorbed percutaneously, raising concerns about salicylate-related adverse effects.

The FDA received over 15,000 public comments on the 2021 proposed order, many of which were substantive and required extensive scientific review. The agency is finalising the PABA and trolamine salicylate provisions first, and will address the remaining provisions including labelling, dosage forms, and maximum SPF levels in future orders.

Timeline:  

Permitted Sunscreen Active Ingredients: Before and After the Removal

Before this order, OTC Monograph M020 permitted 17 sunscreen active ingredients. With the removal of PABA and trolamine salicylate, 15 active ingredients remain permitted. The table below lists all 17 substances, their CAS numbers, and their regulatory status.

What this means for you

1. Confirm whether your sunscreen formulations contain PABA or trolamine salicylate. Verify your formulations and raw material declarations to confirm the absence of both substances. 

2. Understand the change in regulatory pathway. After the order takes effect, a sunscreen product containing PABA or trolamine salicylate will no longer be eligible for marketing under OTC Monograph M020. Such a product would instead be regulated as a new drug and require FDA approval through the new drug application process before it could be marketed.

3. Review your supply chain documentation now, not 2027. If you source sunscreen actives or finished products from third-party manufacturers, request written confirmation that neither PABA nor trolamine salicylate is present in the materials supplied to you. This is particularly important if your products are manufactured in markets where these ingredients remain permitted. A supplier declaration today is simpler and less costly than a reformulation or regulatory filing later.

4. Decide whether reformulation is necessary, and if so, start early. For most formulators, reformulation will be the practical route. The 15 remaining monograph actives offer a workable range of UVB and UVA options. However, substituting actives may affect SPF, broad-spectrum performance, water resistance, sensory profile, and stability. These attributes require re-testing. If your products currently contain PABA or trolamine salicylate, begin reformulation planning well ahead of the deadline.

5. Monitor further amendments to the sunscreen monograph. The FDA is still working through other provisions from the 2021 proposed order, including labelling, dosage forms, and maximum SPF levels. These will be addressed in future orders. Companies supplying sunscreens to the US market should monitor these developments.

For further information, the final order OTC000008-1 is available on the FDA's OTC Monographs portal. Should you require support with US sunscreen compliance, formulation review, or supplier documentation, please do not hesitate to contact us.

Reference:  FDA Final Administrative Order OTC000008-1, Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, and Related Information; Aminobenzoic Acid (PABA) and Trolamine Salicylate (10 September 2026)

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