FDA has added bemotrizinol to the US sunscreen monograph under specified conditions. The agency announced the decision on 9 June 2026, describing protection against UVA and UVB. Check the permitted format and supply route before planning a formula and its tests.
US sunscreens are regulated as drugs. The finished product needs to meet the monograph and other applicable requirements.
Check the conditions before making prototypes
Final Administrative Order OTC000039 was issued on 10 June and corrected for minor typographical errors on 10 August. It states an effective date of 9 August 2026, subject to the statutory dispute provision.
The order permits bemotrizinol at up to 6% under its conditions for adults and children aged six months and older. It covers oils, lotions, creams, gels, butters, pastes, ointments, sticks, and sprays, with conditions on sprays: propellant must be absent or isolated from the formulation. It does not permit powders or direct contact between the formulation and aerosol propellant. Combinations with PABA or trolamine salicylate are excluded.
In a separate September 2026 order, FDA provided for removal of PABA and trolamine salicylate from the sunscreen monograph. That order states an effective date of 11 September 2027, subject to the statutory dispute provision.
Read the complete order for the proposed formulation and delivery system. A cream brief and a spray brief do not have identical regulatory boundaries.
Establish the supply route
The order provides 18 months of exclusivity for DSM Nutritional Products LLC and relevant licensees, assignees, or successors, following the effective date and beginning when DSM may lawfully market under it. BASF announced on 10 August that its DSM agreement granted co-exclusive rights to market and sell bemotrizinol as Tinosorb S during that period.
Ask the prospective supplier how the arrangement applies to the proposed supply and launch. Keep its answer with the material specification and commercial terms.
Test the sunscreen you intend to sell
FDA distinguishes SPF, broad-spectrum protection, and water-resistance claims. Set the intended claims and format before selecting the evaluation programme. Water resistance requires testing and the applicable 40- or 80-minute statement.
Including a permitted filter does not establish the finished product’s SPF or other claims. Compare candidate formulas against the same brief, including spreading, finish, dispensing, and reapplication.
US drug stability requirements include a written testing programme, suitable methods, and the marketed container-closure system. Where accelerated data support a tentative expiry, continuing studies are required to verify it. Agree the commercial pack early enough to include it in that work.
Describe the regulatory route accurately
Qualifying OTC drugs can enter the market through the monograph route without an individually approved drug application when they meet the monograph and other applicable requirements. When describing a sunscreen launch, state its demonstrated performance and the regulatory route used. Distinguish the monograph order from an individual approval of the brand’s product.
