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For Sunscreen Manufacturers The Clock Is Ticking…

The U.S. Food and Drug Administration (FDA)’s deadline for most sunscreen manufacturers to comply with new labeling rules is only 10 days away.

In June 2011, FDA issued a final rule for the labeling of sunscreens being marketed without an approved application (i.e., being marketed under the OTC monograph). The final rule drastically changed the labeling requirements and was set to go into effect in June 2012. [1] FDA extended the deadline to December 17, 2012 for products with annual sales greater than $25,000. Products with annual sales of less than $25,000 will have until December 17, 2013 to comply. After the 17th, all manufacturers of products with annual sales greater than $25,000 may not introduce sunscreens that are not compliant with the new rule into the marketplace.

A product’s labeling statements are contingent upon whether the product passes the new broad spectrum testing procedures published in the final rule. Broad spectrum sunscreens with SPF values of 15 or greater will be permitted to make claims related skin cancer and early skin aging. Non broad spectrum sunscreens will be required to include a warning that the product only protects against sunburn, not skin cancer or early skin aging.

Sunscreen manufacturers must make sure that their product labeling is in order to avoid potential misbranding charges. For more information about new sunscreen labeling requirements or any other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or phone Registrar Corp: +1-757-224-0177.





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