FDA Proposes First New Sunscreen Active Ingredient Approval in 25 Years with Bemotrizinol
核心洞察
The FDA announced a formal proposal on December 11 to add bemotrizinol to the list of approved active ingredients for over-the-counter sunscreens, marking the first major sunscreen-related approval since 1999.
Bemotrizinol provides broad-spectrum protection against both UVA (搜索) and UVB (搜索) rays with low skin absorption and minimal irritation, offering superior stability compared to existing chemical filters that break down in sunlight.
The ingredient has been available in Europe, Australia, and Asian countries for years, with U.S. approval delayed due to regulatory classification of sunscreens as drugs rather than cosmetics.
The Food and Drug Administration announced a formal proposal on December 11 to add bemotrizinol to the list of approved active ingredients for over-the-counter sunscreens, representing the first major sunscreen-related approval since 1999. The move addresses a significant gap in U.S. sunscreen innovation, where Americans have had access to only 16 active sunscreen ingredients compared to over 30 approved filters available to formulators in Japan.
Superior Protection Profile
Bemotrizinol, also known as BEMT, offers distinct advantages over existing chemical sunscreen filters available in the United States. According to the FDA, the ingredient "provides protection against both ultraviolet A and B rays, has low levels of absorption through the skin into the body, and rarely causes skin irritation." Should BEMT approvals be finalized, it will be considered safe and effective by the FDA and recommended for use for adults and children ages six months and older.
Dr. Henry Lim, former chair of dermatology at Henry Ford Health in Detroit and past president of the American Academy of Dermatology (搜索), explained the significance of broad-spectrum protection: "The 'B' is 'burning rays,' which causes sunburn. The 'A' is the 'aging ray,' which causes tanning reaction, wrinkle formation." Both types of UV rays contribute to skin cancer (搜索) risk.
Unlike current chemical filters available in the U.S., which either protect against UVA (搜索) or UVB (搜索) individually, bemotrizinol provides broad-spectrum protection on its own. "It's a broad-spectrum chemical sunscreen that's far more stable. It would not degrade upon exposure to sunlight," Lim noted.
Enhanced Safety and Tolerability
The ingredient addresses several concerns associated with existing chemical sunscreens. Dr. Steven Wang, chief of dermatology at Hoag Memorial Hospital Presbyterian in Newport Beach, California, highlighted bemotrizinol's safety profile: "It does not penetrate the body surface and does not absorb into the bloodstream, so it has a good safety profile."
Dr. Adam Friedman, professor and chair of dermatology at the GW School of Medicine and Health Sciences in Washington, D.C., emphasized the tolerability advantages. Chemical UV filters "are irritating at baseline, let alone if someone has acne (搜索), rosacea (搜索), eczema (搜索) — it's hard for people to be adherent to them because they sting." He added that bemotrizinol "does seem to be better tolerated in comparison to other UV filters."
Formulation Advantages
Cosmetic chemist Kelly Dobos, who attended the 2025 Sunscreen Symposium, praised bemotrizinol's efficiency in formulation. The ingredient provides "true broad-spectrum protection with two distinct absorption peaks, one in the UVA (搜索) range and one in UVB (搜索)," she explained. "Unlike older filters that often require high concentrations to achieve adequate SPF, BEMT allows chemists to use lower overall levels of actives while still meeting high SPF and UVA protection targets."
The improved formulation capabilities may enhance the consumer experience. "We can make products with lighter texture and less greasiness in formulations. And, like other organic filters, it's transparent on the skin," Dobos noted.
Regulatory Timeline and Industry Impact
BEMT is manufactured by DSM-Firmenich (搜索), which has been pursuing U.S. approval for 20 years at a cost of roughly $20 million to bring the ingredient to market. The lengthy approval process reflects the regulatory framework in the United States, where sunscreen filter ingredients are classified as over-the-counter drugs rather than cosmetics, requiring clinical trials to test for safety and effectiveness.
"In Europe, they're not looked at that way," Friedman explained. "That's why they can come out with things much faster."
FDA Commissioner Dr. Marty Makary acknowledged the regulatory delays in a statement: "The agency has historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad. We're continuing to modernize the regulation of sunscreen and other over-the-counter drug products. Americans deserve timely access to the best safe, effective, and consumer-friendly over-the-counter products available."
Ben Nichols, an FDA spokesman, indicated that the agency expects the final order will come sometime next summer or fall, with sunscreen products containing bemotrizinol potentially available in the U.S. as early as late 2026.
Clinical Significance
The American Academy of Dermatology (搜索) has endorsed the approval. AAD president Susan C. Taylor, MD, FAAD, emphasized the clinical importance: "Unprotected exposure to UV rays is a major risk factor for skin cancer (搜索), the most common cancer in the United States," noting that one in five Americans will develop skin cancer in their lifetime. "The Academy has been advocating for many years for the availability of more sunscreen options for US consumers. The United States lags behind many other countries that have nearly twice as many approved sunscreen ingredients."
The proposal must undergo a public comment period before the FDA issues its final order. Starting December 12, interested parties can participate in the public comment process, allowing Americans to share direct feedback with the FDA regarding the proposal.