FDA Sunscreen Regulation Is Moving: What PABA, Trolamine Salicylate and Bemotrizinol Mean for K-Beauty

4 days ago

3 min read

For Korean beauty brands planning to enter or expand in the U.S. market, sunscreen deserves particular regulatory attention.

In September 2026, the U.S. Food and Drug Administration (FDA) issued a final administrative order amending OTC Monograph M020 for sunscreen drug products. The order removes PABA (aminobenzoic acid) and trolamine salicylate as permitted sunscreen active ingredients because FDA determined that the ingredients are not generally recognized as safe and effective (GRASE) for sunscreen use under the conditions of the monograph.

The final order becomes effective on September 11, 2027.

That date matters for brands developing or maintaining sunscreen products for the U.S. market.

What Is FDA Sunscreen Regulation Changing?

Under the final order, PABA and trolamine salicylate will be removed from OTC Monograph M020.

Once the order becomes effective, sunscreen drug products containing either ingredient would no longer qualify for marketing under the OTC monograph. They would instead be considered new drugs and would require an approved application under Section 505 of the FD&C Act to be legally marketed.

At the same time, FDA stated that it is not aware of any sunscreen drug products containing PABA or trolamine salicylate currently marketed in the United States.

Therefore, the immediate market impact may be limited.

But the regulatory signal is much broader.

FDA Is Actively Updating the U.S. Sunscreen Framework

The PABA and trolamine salicylate order is particularly notable because it is part of FDA's ongoing work stemming from the 2021 proposed order for sunscreen products.

FDA has stated that the remaining proposals from the 2021 order will be addressed through future order(s). These proposals include issues related to sunscreen active ingredients and other conditions governing OTC sunscreen products.

And there has already been another major development.

In June 2026, FDA issued a final order adding bemotrizinol to OTC Monograph M020. FDA described this as the first new sunscreen active ingredient added to the OTC monograph in decades.

In other words, the U.S. sunscreen framework is not static.

It is evolving.

Why This Matters for K-Beauty

This is especially relevant to Korean beauty brands because sunscreen is one of the categories where Korean and U.S. regulatory systems can differ significantly.

In Korea and other markets, sunscreen products may be regulated under a cosmetics or functional-cosmetic framework. In the United States, however, sunscreen is regulated as an OTC drug and must satisfy applicable FDA requirements for nonprescription drugs.

That means a Korean sunscreen formula cannot simply be transferred to the U.S. market based on the fact that it is already legally marketed in Korea.

The active ingredients, concentrations, dosage form, labeling, claims, and other applicable requirements need to be evaluated against the U.S. framework.

What Brands Should Do Now

For Korean brands and private-label companies preparing sunscreen products for the U.S., a practical approach is to review regulatory requirements before committing to a final formula.

This can include:

1. Screen the active ingredients

Confirm that each sunscreen active ingredient is permitted under the applicable U.S. OTC framework.

2. Evaluate the U.S. formulation separately

The Korean-market formula and U.S.-market formula may need to be treated as separate regulatory projects.

3. Review the entire product, not only the active

Active ingredients are only one part of sunscreen compliance. Dosage form, labeling, claims, and other monograph conditions also matter.

4. Monitor FDA Sunscreen Regulation Updates

As FDA continues to address the 2021 sunscreen proposals, future orders may affect how brands formulate and market sunscreen products in the United States.

The Bigger Takeaway

The latest FDA action does not mean that Korean sunscreen brands currently using PABA or trolamine salicylate are facing an immediate U.S. market disruption. FDA says it is not aware of sunscreen products containing these ingredients currently being marketed in the United States.

The more important takeaway is that U.S. sunscreen regulation is actively evolving.

For K-Beauty brands, regulatory review should happen at the beginning of the U.S. product development process — not after the Korean formula, packaging, and launch strategy have already been finalized.

A successful U.S. sunscreen launch starts with a formula designed for the U.S. regulatory environment.