FDA Strengthens Sunscreen Testing And Label Requirements
This article was originally published in The Tan Sheet
Executive Summary
As early as June 2012, sunscreens that fail “broad spectrum” tests or have an SPF less than 15 must warn that they have not been shown to prevent cancer or early skin aging, according to an FDA final rule.
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CDER's enforcement policy guidance for OTC monograph sunscreens clarifies that spray sunscreens are included in the agency's enforcement discretion. But CDER closes the door on other dosage forms that it also identified in its 2011 ANPR for whether delivery formats other than lotions, creams or other traditional forms would be eligible for the monograph.
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