The US Food and Drug Administration (FDA) has put forward a proposal to include bemotrizinol as an authorised active component in over-the-counter (OTC) sunscreen formulations.
The regulator said its proposal is based on the assessment of data indicating that bemotrizinol provides protection against both UVA and UVB radiation.
Its initiative is aimed at advancing sunscreen innovation within its Office of Nonprescription Drugs.
The data showed minimal systemic absorption when applied to the skin and are associated with a low incidence of skin irritation, the regulator said in a statement.
If the order is finalised as proposed, bemotrizinol would be classified as “generally recognised as safe and effective” (GRASE) for use in sunscreens formulated for adults and for children from six months of age.
The OTC monograph system allows sunscreen products to be sold without an approved drug application, provided they adhere to established conditions, including authorised active substances, intended uses and permitted dosages.
Amendments to monographs can be made through administrative orders.
DSM Nutritional Products has lodged an OTC Monograph Order Request seeking to add bemotrizinol, at concentrations of up to 6%, to the existing sunscreen monograph.
Although bemotrizinol is commonly used in several other countries, the ingredient has not yet appeared in any FDA-reviewed drug product, nor has it been part of the US sunscreen monograph.
The agency reiterated that broad-spectrum sunscreens with an SPF of 15 or higher contribute to preventing sunburn and lowering the risk of skin cancer and premature skin ageing when used as directed alongside measures such as protective clothing and limited sun exposure.
The FDA is inviting stakeholders and the public to submit comments on the proposed order.
A final order adding bemotrizinol to OTC Monograph M020 will be issued if the agency concludes the substance meets its standard of being generally recognised as safe and effective.
