FDA Opens the Door to a New Sunscreen Active Ingredient After More Than 20 Years

The U.S. sunscreen market has often been seen as conservative compared with other major cosmetic and personal care markets. While consumers in Europe, Asia and other regions have had access to a broader range of modern UV filters for years, the U.S. framework for over-the-counter sunscreen products has moved at a slower pace.

That may now be changing.

• Why this matters for sunscreen brands

• A regulatory opportunity, but not a shortcut

• What companies should do next

Bemotrizinol: New sunscreen active ingredient after more than 20 years in the United States

On June 9, 2026, the U.S. Food and Drug Administration announced the addition of bemotrizinol to the list of permitted sunscreen active ingredients under the OTC sunscreen monograph. This is a relevant regulatory milestone for the industry, as it represents the first new sunscreen active ingredient added to the OTC monograph since the late 1990s.

Bemotrizinol is not a completely new ingredient from a global perspective. It has already been used in sunscreen products in Europe and in several other international markets for many years. What is new is its formal inclusion within the U.S. OTC sunscreen monograph, allowing companies to consider it as part of their U.S. sunscreen strategy, provided the applicable monograph requirements are met.

Why this matters for sunscreen brands

In the United States, sunscreens are regulated as OTC drugs when they are intended to help prevent sunburn or provide SPF protection. This means that a sunscreen product may be marketed without an individual approved drug application only if it complies with the conditions established in the relevant OTC monograph.

These conditions include, among others, the permitted active ingredients, concentration limits, labeling requirements, indications, warnings, directions for use and other technical specifications.

The inclusion of bemotrizinol may therefore create new formulation opportunities for brands interested in the U.S. market. According to the FDA announcement, bemotrizinol provides protection against both UVA and UVB rays and has low levels of absorption through the skin. The FDA considers the ingredient generally recognized as safe and effective for use in sunscreens by adults and children aged 6 months and older, within the conditions established by the monograph.

From a business perspective, this may be especially relevant for international brands already familiar with this ingredient in other markets. However, it is important not to assume that a formula sold in Europe or elsewhere can automatically be placed on the U.S. market without adaptation.

A regulatory opportunity, but not a shortcut

The FDA’s decision is an important signal for innovation, but sunscreen compliance in the U.S. remains highly technical.

Brands should carefully review whether their product fully meets the U.S. OTC sunscreen monograph requirements. This includes checking the active ingredients, permitted concentrations, SPF and broad-spectrum testing, Drug Facts labeling, claims, directions, warnings, establishment registration, drug listing and manufacturing requirements.

It is also important to distinguish between cosmetic positioning and OTC drug positioning. In the U.S., claims related to SPF, sunburn prevention or UV protection generally bring the product into the OTC sunscreen framework. A product cannot be treated as a simple cosmetic if its intended use is to protect the skin from the sun in the way regulated by the OTC monograph.

For companies already selling sunscreen products internationally, this update may be a good moment to review their U.S. market strategy. Some formulas may become more commercially attractive, but they will still require a detailed regulatory gap assessment before launch.

What companies should do next

Companies interested in launching or updating sunscreen products in the United States should consider the following steps:

First, review whether bemotrizinol is relevant for the intended formulation and whether the concentration and combination with other UV filters are compatible with the U.S. OTC sunscreen monograph.

Second, assess the full product classification in the U.S. A sunscreen claim normally means OTC drug compliance, not only cosmetic compliance.

Third, review the label carefully. U.S. sunscreen labeling follows a specific Drug Facts format and includes mandatory warnings, directions and indications.

Finally, make sure that the establishment and product listing obligations are properly addressed before commercialization.

The addition of bemotrizinol is a positive development for the sunscreen sector, particularly for international brands looking at the U.S. market. However, successful market access will still depend on a careful review of the formula, claims, testing and labeling.

Belab Services supports cosmetic, OTC and sunscreen brands with U.S. regulatory strategy, FDA OTC compliance, label review, establishment registration and product listing.

For more information or assistance, please contact us at contact@belabservices.com.