FDA on Sunscreens

In January we told you about some of FDA’s plans for 2011. The agenda listed 18 types of over the counter drug products that are the subject of proposed rulemaking or other agency review.  Back in June FDA completed one agenda item, review of proposed rules for sunscreen products, by publishing four documents:  a guidance document, a proposed rule, an announcement of proposed rulemaking and one final rule. This product sector has been subject to changing unclear regulation since 1978 when FDA first announced its intention to regulate sunscreen products as drugs rather than as cosmetics. Since that time much has been learned about both the effect of sun on the skin and how various sunscreens work.  This has led to a new labeling term for sunscreens: broad spectrum. To use this term sunscreen manufacturers will have to demonstrate through testing that their product reduces the effect of both UVB rays that cause sunburn and UVA rays that affect skin aging and contribute to development of skin cancer. More information on this claim and the testing required to meet the claim can be found in the final rule: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use .  This rule becomes effective June 18, 2012 and in addition to allowing the ‘broad spectrum’ claim, it also prohibits the use of the terms ‘waterproof’, ’sweatproof’ or ‘sunblock’..

In addition to this final rule FDA issued an advance notice of proposed rulemaking that seeks information on the safety and effectiveness of spray-on sunscreens.  The agency also proposed limiting SPF claims to 50+ since there is insufficient data that an SPF greater than 50 actually provides greater benefit.

Because sunscreen regulations have been in flux for the past 23 years, FDA also issued a guidance document to provide industry information on the types of sunscreen products that may be marketed without risk of FDA enforcement action.  Many sunscreens currently on the market contain ingredients that FDA has not reviewed or approved. The agency has not taken enforcement action against such products since there were no clear regulations to follow. Now FDA is stating that products that contain ingredients that were listed in the (still) tentative final monograph published in 1999 (see list at the end of this message) and which have been tested for effectiveness using methods included in FDA rules published in 2011, 2007 or 1999 may be marketed without enforcement actions if they comply with the new rules on claims.

It will be interesting to see which of the other 17 OTC categories FDA tackles next.  Whether it is cough and cold medications, weight control, antacid, antimicrobial or skin protectant products, the OTC team at Bioscience Translation & Application will be working to remain up to date in order to provide our clients with top-notch regulatory support.  Contact us with your question regarding how your product is regulated by FDA.

The following active ingredients were listed in the 1999 Tentative Final Monograph, with GRASE maximum concentrations as shown:

·       Aminobenzoic acid (PABA), 15 percent
·       Avobenzone, 3 percent
·       Cinoxate, 3 percent
·       Dioxybenzone, 3 percent
·       Ensulizole, 4 percent
·       Homosalate, 15 percent
·       Octinoxate, 7.5 percent
·       Octisalate, 5 percent
·       Octocrylene, 10 percent
·       Oxybenzone, 6 percent
·       Padimate O, 8 percent
·       Sulisobenzone, 10 percent
·       Titanium dioxide, 25 percent
·       Trolamine salicylate, 12 percent

·       Zinc Oxide, 24 percent

These ingredients may be used at these concentrations in combinations as long as each active ingredient contributes a minimum SPF of 2 to the finished product, except that avobenzone may not be combined with aminobenzoic acid (PABA), menthyl anthranilate padimate O, titanium dioxide, and zinc oxide.

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