GRS Blog

The US FDA announces significant changes to Over-The-Counter sunscreen products

14/6/2011

The US FDA today announced new final and proposed requirements for over-the-counter (OTC) sunscreens currently marketed in the United States. As part of FDA’s ongoing effort to ensure that sunscreens meet modern-day standards for safety and effectiveness, these new requirements, as well as several proposed changes for future rules, are outlined in four regulatory documents: a Final Rule, a Proposed Rule, an Advance Notice of Proposed Rulemaking (ANPR), and a Draft Guidance for Industry. 

The final rule addresses such matters as health claims allowed under “Broad Spectrum” designation, Drug Facts information, waterproof or sunblock claims, and water resistance claims. The rule will help consumers choose the right sun protection for themselves and their families to not only help prevent sunburn, but also to help reduce the risk of skin cancer and early skin aging when used with other sun protection measures. Consumers will see the new labels no later than the summer of 2012.

In the proposed rule, FDA also seeks information and data regarding additional clinical benefit of sunscreen products with SPF values greater than 50 and is proposing labeling for products above SPF 50. In the ANPR, the agency is requesting data on particular dosage forms and data supporting the effectiveness and the safety of sunscreen sprays. Finally, a draft guidance for industry outlines information to help manufacturers label and test their products in light of the new final rule. The guidance also addresses FDA’s enforcement approach to the final rule, proposed rule, and ANPR. 

Author: Greer Deal, Director of Global Regulatory Services (GRS)