The U.S. Food and Drug Administration added bemotrizinol, also called BEMT, to the over-the-counter sunscreen monograph in June 2026. The final order took effect on August 9, 2026 and permits BEMT at concentrations up to 6 percent when the finished sunscreen meets the conditions in the monograph.
For product teams, the change creates new formulation options. BEMT is a broad-spectrum UV filter that absorbs both UVA and UVB radiation. It can be combined with permitted sunscreen actives under the conditions in the FDA order. The final formula, dosage form, labeling, SPF testing, broad-spectrum testing, stability work, and other drug requirements still determine whether a product is ready for market.
InSpec Solutions has developed multiple BEMT sunscreen systems for brand programs. The company formulates and manufactures SPF lotions, sticks, powders, and bag-on-valve continuous sprays at its FDA-registered facility in Holly Hill, Florida. Formulation, stability support, analytical work, filling, and retail-ready packing can stay with one manufacturing partner.
Brands should start with the intended format, target SPF, sensory profile, packaging, claims, launch date, and expected annual volume. A technical review can then identify the right development path and required testing. Existing sunscreen brands can also assess whether BEMT supports a line extension or a future reformulation.
InSpec is accepting briefs for BEMT sunscreen programs.
Visit: https://inspecsolutions.com/sunscreen-manufacturing to review its sun-care capabilities or request a manufacturing discussion at https://inspecsolutions.com/contact.
