BASF's PEG-25 PABA
This article was originally published in The Rose Sheet
Executive Summary
Sunscreen ingredient's monograph status "is dependent on the outcome of [the] broader policy determination" of the acceptability of foreign marketing data and the meaning of "to a material extent and for a material time," FDA tells the German company in a recent letter. The agency says it "anticipates a public rulemaking procedure that may take some time to complete" and pointed out that the company has the option of submitting an NDA for ethoxylated ethyl-4-aminobenzoate (PEG-25 PABA). BASF requested that FDA reopen the administrative record for sunscreens to include PEG-25 PABA as a Category I ingredient ("The Rose Sheet" Feb. 14, p. 7)