FDA Issues Final Rule on Sunscreen Labeling

On June 14, 2011, the Food and Drug Administration (FDA) published a final rule regarding sunscreen labeling. The final rule sets forth labeling for sun protection factor (SPF) and broad spectrum protection, establishes labeling and testing for water resistance, and addresses other elements of labeling, including directions for use and warnings. The final rule also identifies specific claims that render a covered product misbranded or would not be permissible on any over-the-counter (OTC) sunscreen product marketed without an approved application. The final rule is part of the FDA’s ongoing effort to ensure that sunscreens meet modern-day standards for safety and effectiveness and help consumers have the information they need so they can choose the right sun protection for themselves and their families. The final rule takes effect for most manufacturers on June 18, 2012. Manufacturers with less than $25,000 in annual sales will have two years to adapt to the new regulations. This summary highlights significant provisions in the final rule.

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