FDA Is OK with Sunscreens

The US Food and Drug Administration today said most sunscreens on the market are in compliance with the deemed final order. The provisions in today’s proposed order are substantively the same as those described in the FDA’s 2019 proposed rule on sunscreens.

The deemed final order essentially preserves the pre-CARES status quo marketing conditions for these sunscreens, as, before CARES was passed, sunscreens were marketed according to nearly identical terms that were described in an FDA enforcement discretion policy. For this reason, the FDA said that most sunscreens on the market are in compliance with the deemed final order. This order will remain in effect until the FDA issues another final order revising it.

The CARES Act required the FDA to issue a proposed revised order by Sept. 27, 2021. The FDA is announcing the availability of the proposed order today that the Agency is using as a vehicle to efficiently transition its ongoing consideration of the appropriate requirements for OTC sunscreens marketed without approved applications from the previous rulemaking process to this new order process.  

The order proposes to update the GRASE status for the 16 active ingredients listed in the deemed final order. It also proposes that dosage forms that are GRASE for use as sunscreens include oils, lotions, creams, gels, butters, pastes, ointments and sticks, and proposes GRASE status for spray sunscreens, subject to testing and labeling requirements. 

The agency will consider comments on the proposed order submitted during a 45-day public comment period before issuing a revised final order (and is considering all comments timely submitted to the 2019 proposed rule to be constructively submitted to the proposed order). The CARES Act specifies that the effective date for the revised final order cannot be earlier than one year after its issuance.