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FDA Institutes Final Order on OTC Sunscreens Under CARES Act

September 28, 2021

The FDA continued its implementation of new authorities for certain over-the-counter (OTC) drugs when it posted a final administrative order for OTC sunscreens.

The final order was required by the 2020 Coronavirus Aid, Relief and Economic Security (CARES) Act, which seeks to reform the way sunscreens and other OTC products marketed without approved applications are regulated in the U.S.

The CARES Act required the FDA to issue a proposed revised order on sunscreens by Sept. 27, 2021.

The 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, the agency said.

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