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Related Experiment Video

Updated: Oct 20, 2025

Studying Chronic Exposure of Mice to Ultraviolet B Radiation

Studying Chronic Exposure of Mice to Ultraviolet B Radiation

Published on: August 19, 2025

Attack on Sunscreens Continues.

Howard Epstein¹

¹EMD Electronics, Surface Solutions, Philadelphia, PA, an affiliate of Merck KGaA, Darmstadt, Germany; howard.epstein@emdgroup.com.

|September 16, 2021

Summary

This summary is machine-generated.

The CARES Act removed the FDA's 2019 deadline for sunscreen regulations. New rules under the CARES Act will allow sunscreens to be generally recognized as safe and effective (GRASE) if they meet FDA-defined conditions.

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Area of Science:

Regulatory Science
Pharmaceutical Policy
Public Health

Background:

The U.S. Food and Drug Administration (FDA) had a November 26, 2019 deadline for a final sunscreen monograph.
The Coronavirus Aid, Relief, and Economic Security (CARES) Act, enacted on March 27, 2020, altered this regulatory timeline.

Purpose of the Study:

To analyze the impact of the CARES Act on FDA sunscreen regulations.
To outline the new framework for over-the-counter (OTC) monograph drugs, including sunscreens.

Main Methods:

Review of legislative changes introduced by the CARES Act.
Analysis of the FDA's revised responsibilities and timelines for sunscreen GRASE (generally recognized as safe and effective) status.

Main Results:

The CARES Act eliminated the original November 2019 deadline for the final sunscreen monograph.
Sunscreens will be considered GRASE if they meet new FDA-defined conditions.
The FDA is mandated to propose revised GRASE requirements within 18 months and will sunset by FY2022.

Conclusions:

The CARES Act modernizes OTC drug regulation, impacting sunscreen approval processes.
New pathways for sunscreen GRASE status are established under the CARES Act.
The regulatory landscape for sunscreens has been significantly reshaped by recent legislation.