FDA Is Looking for New Data on Sunscreen Ingredients

Drug Topics JournalDrug Topics April 2019
Volume 163
Issue 4

As sunscreens have evolved, new safety considerations are warranted.


The FDA is seeking further information on PABA, trolamine salicylate, and 12 other compounds commonly used in sunscreen to determine safety and effectiveness.

The request comes as a part of proposed rule to update regulatory requirements and establish a final monograph for nonprescription OTC sunscreens distributed in the United States. Scott Glottlieb, MD, commissioner of the FDA, says that formulations have evolved as manufacturers have innovated their products, warranting new considerations from the FDA.

Some products are allowed to be sold without specific FDA clearance so long as they are generally regarded as safe and effective. The new rules would clear sunscreens with two active ingredients-zinc oxide and titanium dioxide-as well as update dosage forms, increase the maximum proposed SPF value, and require product labels that better assist customers in identification of active ingredients and other critical information

The full press release can be accessed here.

Before the proposed rule becomes final, the FDA is seeking public comment until May 28, 2019. Comments can be submitted electronically following this link or by mail to the FDA.

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