A Common FDA Refrain: BASF, L’Oreal Sunscreen TEAs Need More Information

08 Sep 2014

After taking no action on sunscreen ingredient TEAs for a decade, FDA has found five applications to be insufficient since February, but is leaving the door open on future approval based on additional safety data.

BASF Corp.and [L'Oreal USA Inc.] are the latest firms FDA is asking to furnish additional information to support time and extent applications to add sunscreen ingredients to the OTC monograph.

After taking no action on sunscreen ingredient TEAs for a decade, FDA has found five applications insufficient since February. The...