Existing Sunscreen Monograph Ingredients Could Fail Proposed Safety Standards

05 Sep 2014

• By Elizabeth Crawford

FDA’s proposed safety standards for sunscreen monograph ingredients might not align with safety evidence supporting current monograph ingredients. Without a safeguard, such as a grandfather clause, these ingredients could face challenges if FDA adopts stricter standards, NDAC committee members worry.

Existing OTC sunscreen monograph ingredients could be vulnerable to removal if FDA approves standards it proposed for evaluating the safety of additional ingredients seeking inclusion in the monograph.

FDA’s proposal to require additional human and non-clinical animal studies to prove a potential OTC monograph sunscreen ingredient is generally...