The US Food and Drug Administration said most sunscreens on the market are in compliance with the deemed final order. The provisions in yesterday’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 announced the availability of the proposed order yesterday 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.