"Our understanding is that the FDA has indicated a delay until September 2020 to finalize the sunscreen monograph," explained Lisa Powers, EVP-public affairs & communications, Personal Care Products Council. "Apparently, the Agency received a significant amount of public comments and is still going through them."
The Act was enacted on November 26, 2014 to provide an alternative process for the review of safety and effectiveness of nonprescription sunscreen active ingredients.
The SIA supplements the FDA’s Time and Extent Application (TEA) regulation with new statutory procedures. The SIA also requires FDA to establish timeframes for review of TEAs for OTC drugs other than sunscreen active ingredients.