By VETTAPHARMA reporter – Derek Roche: The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted active ingredients in over-the-counter (OTC) sunscreen products, marking the first addition of a new sunscreen active ingredient to the OTC sunscreen monograph since the late 1990s.
The decision allows manufacturers to formulate sunscreen products containing bemotrizinol at concentrations of up to 6% without requiring an approved new drug application, provided products comply with applicable OTC monograph requirements. The action follows an OTC monograph order request submitted by DSM Nutritional Products LLC and completes a regulatory review process that began with a proposed order issued on December 12, 2025.
According to the FDA, bemotrizinol provides protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation and demonstrates low systemic absorption through the skin. The agency determined that bemotrizinol is generally recognized as safe and effective (GRASE) for use in sunscreen products by adults and children aged 6 months and older.
FDA officials highlighted the approval as an example of the streamlined OTC monograph process established under the CARES Act. The final order was issued approximately seven months after publication of the proposed order and follows review of public comments submitted between December 12, 2025, and January 26, 2026.
Bemotrizinol has been used in sunscreen products in Europe and numerous international markets for years. FDA stated that the action is intended to promote innovation and expand sunscreen options available to U.S. consumers while maintaining established safety and efficacy standards.
Quick FAQs
1. What Is Bemotrizinol?
Bemotrizinol is a sunscreen active ingredient that provides broad-spectrum protection against both UVA and UVB radiation and has been used in sunscreen products in Europe and other international markets for many years.
2. What Happened?
The FDA issued a final order adding bemotrizinol to the OTC sunscreen monograph, making it the first new sunscreen active ingredient added to the U.S. monograph since the late 1990s.
3. What Regulatory Process Was Used?
The ingredient was added through the OTC monograph administrative order process established under the CARES Act. DSM Nutritional Products LLC submitted the monograph order request, which was subsequently reviewed by the FDA.
4. Who Can Use Sunscreens Containing Bemotrizinol?
The FDA determined that bemotrizinol is generally recognized as safe and effective for use in adults and children aged 6 months and older.
5. What Were The Key Regulatory Findings?
FDA concluded that bemotrizinol provides protection against UVA and UVB rays, exhibits low absorption through the skin, and may be included in OTC sunscreen products at concentrations of up to 6%.
6. Why Is This Important?
The decision expands sunscreen ingredient options available in the United States, introduces the first new OTC sunscreen active ingredient in more than two decades, and demonstrates the use of the streamlined regulatory pathway created under the CARES Act.
