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Article
Sunscreen regulations take effect
Washington - The Food and Drug Administration’s final rule for sunscreen labeling requirements went into effect Dec. 17, impacting manufacturers with annual product sales of more than $25,000.
Sunscreen regulations take effect
Jan 4, 2013
By: Sarah Thuerk
Dermatology Times E-News
Washington - The Food and Drug Administration’s final rule for sunscreen labeling requirements went into effect Dec. 17, impacting manufacturers with annual product sales of more than $25,000.
The FDA’s final rule calls for some manufacturers of over-the-counter sunscreens to pass new broad-spectrum tests. Broad-spectrum sunscreens with sun protection factor (SPF) values of 15 or higher can make claims related to skin cancer protection and early skin aging. Those products that are not broad-spectrum must include a warning that the product will only protect against sunburn, not skin cancer or photoaging.
Manufacturers producing sunscreen products with annual sales of less than $25,000 have until Dec. 17, 2013 to comply to the final rule, according to the FDA. After that date, any sunscreen manufacturers whose products have annual sales of more than $25,000 cannot introduce products to the marketplace that are not compliant with the new rule.
