The U.S. Food and Drug Administration (FDA) has taken a significant step toward modernizing sunscreen regulation by adding bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products. This marks the first time in more than two decades that the FDA has expanded the list of approved sunscreen active ingredients. 

For consumers, the announcement means greater choice and access to innovative sun protection products. For sunscreen manufacturers, brand owners, and importers, it signals new opportunities in the U.S. market, along with important regulatory considerations. 

As companies evaluate how this change may affect their product portfolios, understanding FDA compliance requirements will remain just as important as understanding the science behind new ingredients. 

A Long-Awaited Regulatory Development 

Bemotrizinol has been used in sunscreen products throughout Europe, Asia, Australia, and other international markets for many years. The ingredient is known for providing broad-spectrum protection against both UVA and UVB rays while maintaining stability when exposed to sunlight. 

The FDA recently finalized an administrative order adding bemotrizinol to the OTC sunscreen monograph, making it the first new active sunscreen ingredient added to the monograph since the late 1990s. The agency determined that the ingredient is generally recognized as safe and effective (GRASE) for use in sunscreen products by adults and children six months of age and older. 

This decision follows years of discussion within the sunscreen industry regarding the gap between sunscreen ingredients available in the United States and those available in many other parts of the world. Because sunscreens are regulated as OTC drugs in the United States rather than as cosmetics, new active ingredients must undergo a rigorous review process before they can be marketed. 

The approval of bemotrizinol demonstrates that the FDA’s updated OTC monograph process can provide a pathway for innovation while maintaining the agency’s safety standards. 

Why Bemotrizinol Matters 

Sunscreen effectiveness depends on the ability to protect skin from both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. 

UVB rays are primarily associated with sunburn, while UVA rays penetrate deeper into the skin and contribute to premature aging and increased skin cancer risk. Effective broad-spectrum protection requires addressing both types of ultraviolet radiation. 

Bemotrizinol has attracted attention because it offers protection across a wide range of the UV spectrum and remains highly stable during sun exposure. In many international markets, it has become a key ingredient in modern sunscreen formulations because it can help manufacturers create products that offer strong protection while maintaining desirable cosmetic characteristics such as lighter textures and reduced residue on the skin. 

For U.S. consumers who have become familiar with international sunscreen products through travel or e-commerce, the addition of bemotrizinol may help close some of the formulation gaps that have existed between the United States and other markets. 

What This Means for Sunscreen Manufacturers 

While the FDA’s decision opens new possibilities, it does not eliminate the extensive regulatory requirements that apply to sunscreen products sold in the United States. 

Many companies are surprised to learn that sunscreen products are regulated as OTC drugs, not cosmetics. As a result, manufacturers must comply with a complex framework of FDA drug regulations. 

Companies interested in introducing new sunscreen products or reformulating existing products should carefully evaluate how the addition of bemotrizinol affects their regulatory strategy.  

Key compliance considerations include: 

Product Labeling Requirements 

FDA-regulated sunscreen products must follow OTC drug labeling requirements, including proper Drug Facts formatting, ingredient declarations, usage instructions, and warning statements. 

When formulations change, labels often require updates to ensure compliance with FDA regulations. Even small modifications can create labeling challenges that must be addressed before products reach the market. 

Learn more about label and ingredient compliance. 

Drug Establishment Registration 

Facilities involved in manufacturing OTC sunscreen products must maintain FDA registration and ensure all required information remains current. 

This requirement applies to both domestic and foreign facilities involved in manufacturing products intended for the U.S. market. 

Learn more about FDA registration for OTC drug products. 

Product Listings and NDC Requirements 

Sunscreen products marketed in the United States must be properly listed with the FDA. Manufacturers must obtain a labeler code, create National Drug Code (NDC) numbers where required, and submit product information through FDA systems. 

As companies explore new formulations containing approved active ingredients, accurate product listing becomes an essential part of maintaining compliance. 

Learn more about product listing for FDA compliance. 

U.S. Agent Requirements 

Foreign manufacturers selling sunscreen products in the United States must designate a U.S. Agent to serve as the FDA’s point of contact. 

This requirement remains critical regardless of whether a company is marketing a longstanding sunscreen formulation or introducing products containing newly approved ingredients. 

Learn more about U.S. Agent services for non-U.S. companies. 

Innovation Creates Opportunity, But Compliance Remains Essential

The approval of bemotrizinol is likely to encourage additional innovation within the sunscreen category. Industry stakeholders have long advocated for modernization of sunscreen regulations, and this decision may provide momentum for future regulatory developments. 

However, innovation often brings increased regulatory scrutiny. 

When new ingredients enter the marketplace, manufacturers must ensure that every aspect of compliance keeps pace with product development. Regulatory gaps can create costly delays, import issues, or enforcement risks that undermine the benefits of bringing innovative products to market. 

For companies entering the U.S. sunscreen market for the first time, the learning curve can be particularly steep. Understanding drug establishment registration requirements, product listings, labeling standards, user fees, and ongoing compliance obligations requires specialized expertise. 

Looking Ahead 

The FDA’s decision to add bemotrizinol to the OTC sunscreen monograph represents one of the most significant sunscreen regulatory developments in decades. It reflects a growing emphasis on balancing innovation with safety and may pave the way for additional advancements in the future. 

For manufacturers, the announcement creates exciting possibilities for product development and market expansion. At the same time, it serves as a reminder that sunscreen products remain subject to a comprehensive set of FDA drug regulations. 

DSM Nutritional Products LLC filed an OTC Monograph Order Request (OMOR) in September 2024 to initiate this review by FDA. When the order goes into effect August 9, 2026, unless disputed, only DSM Nutritional Products LLC (or the licensees, assignees, or successors in interest of DSM with respect to the subject of this final order) have exclusivity for 18 months following the effective date of the order to market drugs per this final order. After that exclusivity period, other manufacturers may start to manufacture sunscreens with this new ingredient. 

As the industry adapts to this new regulatory landscape, companies that prioritize both innovation and compliance will be best positioned for long-term success. 

For businesses seeking to introduce new sunscreen products, update formulations, or ensure ongoing FDA compliance, working with experienced regulatory professionals can help simplify the process and reduce risk at every stage of market entry.