By Deanna Utroske, 23-Nov-2016
To expedite the review and approval process for over-the-counter sun care, the US Food and Drug Administration issued new guidelines this week, outlining the data required to demonstrate that
sun care ingredients are generally recognized as safe and effective.
While a majority of the FDA’s 18 pages of safety and effectiveness guidelines for sun screen focuses on ingredient safety data, final formulation testing will almost certainly continue to be part of most final sunscreen orders. And the closing section of the FDA’s new recommendations covers this aspect of sun care approval.
That section explains that the “FDA’s current thinking is that final formulation safety testing of nonprescription sunscreens would not generally call for an in vivo study. Instead, FDA expects that the conditions of marketing specified for sunscreen active ingredients in final sunscreen orders would require manufacturers to perform in vitro permeation testing before marketing each new formulation.”