FDA Sunscreen Regulatory Update: PABA and Trolamine Salicylate Removed from OTC Monograph M020

The U.S. Food and Drug Administration (FDA) is beginning to make meaningful changes to the regulatory framework governing OTC sunscreen products.

In 2026, the FDA took two significant actions involving OTC sunscreen active ingredients. In June, the agency added bemotrizinol (BEMT) to OTC Monograph M020—the first new sunscreen active ingredient added to the U.S. OTC sunscreen monograph in 20 years. In September, the FDA finalized an order removing PABA (aminobenzoic acid) and trolamine salicylate from the same monograph.

These actions are important not only because of the individual ingredients involved, but because they indicate that the U.S. sunscreen regulatory framework is beginning to evolve after a long period of relative stability.

FDA Adds a New Sunscreen Active Ingredient After 20 Years

On June 10, 2026, the FDA issued Final Administrative Order OTC000039, adding bemotrizinol (BEMT) to OTC Monograph M020.

The FDA described this as the first new sunscreen active ingredient added to the OTC sunscreen monograph in 20 years.

Under the final order, BEMT may be used at concentrations up to 6%, subject to specified conditions and applicable monograph requirements. The order became effective on August 9, 2026.

The significance extends beyond BEMT itself.

After many years without a new active ingredient being added to the OTC sunscreen monograph, this action demonstrates that the FDA is actively revisiting the regulatory framework for sunscreen products.

FDA Removes PABA and Trolamine Salicylate

On September 10, 2026, the FDA issued Final Administrative Order OTC000008-1, removing PABA and trolamine salicylate from OTC Monograph M020.

The FDA concluded that the two ingredients are not GRASE (Generally Recognized as Safe and Effective) for use as sunscreen active ingredients based on the available evidence and identified significant safety concerns.

The order becomes effective on September 11, 2027, unless it is disputed through the applicable statutory process.

The immediate market impact is expected to be limited. The FDA stated that it is not aware of any sunscreen drug products containing PABA or trolamine salicylate currently marketed in the United States.

However, the regulatory significance is broader than the number of products currently affected.

The Bigger Picture: FDA Is Moving Forward With Its Sunscreen Framework

The PABA and trolamine salicylate action represents a portion of the FDA's broader effort to update the OTC sunscreen framework.

In 2021, the FDA proposed Administrative Order OTC000008, addressing a range of issues including sunscreen active ingredients, SPF, broad-spectrum requirements, dosage forms, labeling, testing, and related conditions for marketing OTC sunscreen products.

The FDA has now finalized the portion of that proposal concerning PABA and trolamine salicylate.

Other elements of the 2021 proposal have not all been finalized. The FDA has indicated that additional issues may be addressed through future administrative orders.

For manufacturers, private-label companies, distributors, and other companies involved in OTC sunscreen products, this creates an important regulatory consideration:

The U.S. sunscreen framework should not be treated as a static set of requirements.

What Companies Should Be Reviewing

The 2026 FDA actions provide a useful opportunity to review how sunscreen products are being developed, manufactured, and maintained in the U.S. market.

1. Review sunscreen active ingredients

Companies should confirm that the active ingredients used in their products remain permitted under the applicable OTC sunscreen framework and that the concentrations and conditions of use are compliant.

This is particularly important when developing new products or modifying existing formulations.

2. Evaluate formulations specifically for the U.S. market

A formulation developed for another market should not automatically be assumed to satisfy U.S. OTC drug requirements.

The active ingredients, concentrations, dosage form, labeling, testing, and other applicable requirements should be evaluated against the current U.S. regulatory framework.

3. Review labeling and claims

Sunscreen products marketed in the United States are subject to drug labeling requirements, including applicable Drug Facts labeling and sunscreen-specific requirements.

Companies should also evaluate whether product claims and marketing communications are consistent with the product's regulatory status and applicable FDA requirements.

4. Monitor future FDA actions

The sunscreen regulatory process is still evolving.

Future administrative orders may address additional elements of the 2021 proposal, potentially affecting requirements related to SPF, broad-spectrum protection, dosage forms, labeling, testing, and other aspects of OTC sunscreen products.

For companies with products already on the market, regulatory monitoring can help identify changes that may require a future product or labeling review.

PCG Regulatory Insight

The most important takeaway from the FDA's 2026 sunscreen actions is not simply that one ingredient was added and two were removed.

The broader signal is that the U.S. OTC sunscreen regulatory framework is beginning to move again after approximately two decades without a new active ingredient being added to the monograph.

For companies operating in this category, five areas should be considered together:

1. Regulatory changeThe OTC sunscreen framework is evolving, and additional changes may follow.

2. Active ingredient eligibilityIngredient status should be reviewed against the current FDA framework rather than relying solely on historical use or regulatory status in other markets.

3. Formulation complianceActive ingredients, concentrations, dosage forms, and the overall formulation need to be evaluated as part of the U.S. regulatory framework.

4. Drug compliance requirementsSunscreen compliance extends beyond formulation to labeling, claims, testing, establishment registration, drug listing, and other applicable requirements.

5. Ongoing regulatory intelligenceFor products that are already marketed or in development, monitoring FDA actions can be an important part of maintaining regulatory compliance and planning future product changes.

The key question is not simply:

“Does this product meet today's requirements?”

It is also:

“Is the product positioned to remain compliant as the U.S. sunscreen framework continues to evolve?”

For OTC sunscreen companies, regulatory compliance should not be viewed solely as a final pre-launch checkpoint.

It should be integrated into product development, regulatory review, and ongoing market maintenance.

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