FDA Grants More Time for New Sunscreen Labels

Posted on May 17, 2012 @ 09:08 am

The FDA extended the compliance dates for the sunscreen labeling and testing requirements. For OTC sunscreen products with annual sales of $25,000 or more (which are the majority of the sunscreen market), FDA has extended the compliance date from June 18, 2012 to December 17, 2012. For OTC sunscreen products with annual sales of less than $25,000, the compliance date has been extended from June 17, 2013 to December 17, 2013. Under the 2011 Sunscreen Final Rule, separate compliance dates for large and small volume manufacturers existed. Both dates are being delayed by six months, according to FDA.

A FDA spokesperson noted that after reviewing the timeline, the agency concluded that although some manufacturers have already implemented the new testing and labeling requirements for some products, others would be unable to complete implementation of the final rule by the original compliance dates for all products.