USA – FDA unveils proposed changes to OTC sunscreen labeling, active ingredients

The US Food and Drug Administration (FDA) is proposing several changes for over-the-counter (OTC) sunscreen products, from new labeling requirements to substantially reducing the number of active ingredients to be generally recognized as safe and effective (GRASE) for marketing.

The proposed order, which was announced on 24 September 2021 and has a 45-day public comment period, closely follows the agency’s 2019 proposed rule on sunscreens. It also includes changes related to the maximum sun protection factor (SPF) labeling, dosage forms considered GRASE, and sunscreen-insect repellent combinations. (RELATED: FDA proposes new rule for sunscreen products, Regulatory Focus 21 February 2019)

The new proposed order on sunscreen products “is an important step in FDA’s effort to follow the latest science,” Therese Michele, director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, said during a press conference to announce the regulatory changes…