FDA Adds a New Sunscreen to the OTC Repertoire

The FDA has approved a new ingredient, bemotrizinol (BEMT), for the OTC sunscreen monograph. This sunscreen has been approved in Europe for decades and is popular in Korea, but it marks the first new sunscreen ingredient cleared by the FDA in 25 years. The FDA classification designates it as “generally recognized as safe and effective” for use in sunscreens by adults and children who are at least 6 months of age.^1,2

Korean and Asian manufacturers have used BEMT widely in sunscreen formulations for many years. Its popularity stems from its broad-spectrum ultraviolet A and B (UVA, UVB) protection, excellent photostability, and ability to contribute to lightweight, cosmetically elegant formulations. These characteristics have made it a common component of many Korean sunscreens that gained international popularity before its addition to the US OTC sunscreen monograph.^3-5

Considered a cosmetic, BEMT will be available in the US in concentrations of 6% or less. Like other sunscreens, BEMT protects against ultraviolet A and B rays, and its transcutaneous systemic absorption is low.⁵

The development team found that it is effective at blocking UV radiation in 2 key regions of the ultraviolet spectrum: one in the UVB range (310 nm) and one in the UVA range (340 nm). Because BEMT absorbs UV light in both the UVA and UVB ranges, it provides broad-spectrum sun protection against wavelengths associated with sunburn, skin aging, and skin cancer.^4,5

BEMT is highly photostable, meaning the ingredient does not break down significantly when exposed to sunlight, especially UV radiation. Many UV filters absorb ultraviolet light and then gradually degrade, losing effectiveness over time. A photostable filter continues to absorb UV radiation without substantial chemical breakdown, so it maintains its protective ability during sun exposure. Data indicate that after 50 minimal erythemal doses, 98.4% of the sunscreen filter remains intact. It helps prevent the photodegradation of other less stable sunscreens like avobenzone.^4,5

In the European Union, BEMT is sold by numerous companies under a number of trade names. CIBA Specialty Chemicals, the product innovator, applied for FDA approval in 2005, so it has already had more than 2 decades of regulatory review. Now part of DSM Nutritional Products LLC’s portfolio, BEMT will be sold under the brand name Parsol Shield and its manufacturer expects it will be available later in 2026. As a new OTC, it will be subject to an 18-month exclusivity period.²

An OTC monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements, including conditions established in its monograph such as permitted active ingredients, uses, and doses. The FDA can modify an OTC monograph through an administrative order, and a drug company may start the process by submitting an OTC monograph order request.

About the Author

Laura Nolan, Med, CPhT, CSPT, is a clinical instructor at the University of Connecticut School of Pharmacy and Pharmaceutical Sciences in Storrs, Connecticut.

REFERENCES

1. Friedman A, Andrews D. What is the sunscreen filter bemotrizinol? EWG. May 19, 2026. Accessed June 15, 2026. https://www.ewg.org/news-insights/news/2026/05/what-sunscreen-filter-bemotrizinol

2. FDA expands sunscreen options for the first time in 20 years. News release. FDA. June 9, 2026. Accessed June 15, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years

3. Bemotrizinol. Drugbank. Accessed June 15, 2026. https://go.drugbank.com/drugs/DB11206

4. Godoy M. 4 things to know about the new sunscreen ingredients the FDA approved. NPR. June 13, 2026. Accessed June 15, 2026. https://www.npr.org/2026/06/13/nx-s1-5856385/sunscreen-skin-protection-bemotrizinol#:~:text=By%20contrast%2C%20bemotrizinol%20offers%20protection,protection%20left%2C%22%20Rogers%20says

5. Wang SQ, Osterwalder U, Lim HW. Pending Food and Drug Administration approval of bemotrizinol: a potential turning point for United States sunscreen formulation. J Am Acad Dermatol. 2026. doi:10.1016/j.jaad.2026.04.1970