6 Days Until FDA Sunscreen Labeling Rule Compliance Deadline; Are You Prepared?

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Registrar Corp reminds industry about the upcoming U.S. FDA OTC Sunscreen Labeling Regulations Compliance Deadline and the requirements necessary to comply.

U.S. FDA Sunscreen Labeling Regulations Assistance by Registrar Corp
All OTC Sunscreen Drug Manufacturers must comply with new U.S. FDA labeling regulations by December 17, 2013.

The deadline for all OTC sunscreen drug companies to comply with new U.S. Food and Drug Administration (FDA) sunscreen regulations is December 17, 2013. After this date, all OTC sunscreens are required to meet the labeling regulations promulgated by FDA.

The FDA published a final rule for OTC sunscreen drug products on May 21, 1999 (64 FR 27666). The final rule added a sunscreen monograph to part 352 of the Code of Federal Regulations, including requirements related to active ingredients, testing requirements, and labeling. FDA subsequently stayed the effective date of the final rule for sunscreen drug products and issued a Delay of Implementation of the Drug Facts Rule as it applies to OTC sunscreen drug products (66 FR 67485, 69 FR 53801).

On June 14, 2011, FDA published a final rule with new requirements for OTC sunscreen labeling and testing, as well as a removal of the delay of implementation. The date to meet compliance was set for June 18, 2012. The compliance date for products with annual sales less than $25,000 subject to this final rule was June 17, 2013 (76 FR 35620).

The agency delayed the compliance dates on May 11, 2012, after a request by industry for more time to implement the requirements of the final rule. The new date to meet compliance was set for December 17, 2012. The compliance date for products with annual sales less than $25,000 subject to this final rule is December 17, 2013 (77 FR 27591).

As December 17th draws near, it is important for manufacturers and distributors of sunscreen drug and drug-cosmetic products to ensure that their labeling meets the new FDA requirements. Products that do not meet these requirements are subject to enforcement action by FDA, including detention and seizure.

Registrar Corp can assist you with the labeling of your sunscreen products, ensuring that the FDA rule is met and your supply chain unencumbered. Our Label & Ingredient Review service will inform you of the regulatory status of your ingredients, check that your labeling follows the format mandated by FDA, and research your product claims to ensure that they are permitted. For more information about drug ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at http://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.

*Learn about the Top 10 Things Industry Needs to Know About U.S. FDA’s New Rules for Sunscreen Products

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David Lennarz

Liviana Callahan
since: 08/2010
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