On June 14, 2011, the United States Food and Drug Administration (FDA) published a final rule for sunscreen Over the Counter (OTC) drug products that mandated revised SPF, Water Resistance and Broad Spectrum testing procedures. The final rule requires specific labeling statements based on the results of these tests. As of December 17, 2013, all OTC sunscreens products were expected to comply with the revised OTC drug regulations. So, are sunscreens a cosmetic or drug?

Many countries define drugs and cosmetics differently from the United States. For example, in some countries, sunscreens are regulated as cosmetics. In the United States, however, sunscreens are regulated as drugs. Cosmetics and drugs are subject to different regulatory requirements in the United States. Please note that some “personal care products” are drugs, or both cosmetics and drugs, under U.S. law.

The use of the term “sunscreen” or claims regarding sun protection on a product’s labeling may cause to be subject to regulation as a drug. However, sunscreen ingredients may also be used in some products for nontherapeutic, nonphysiologic uses such as a color additive or to protect the color of the product. I n order to avoid consumer misunderstanding, a cosmetic product that contains a sunscreen ingredient and uses the term “sunscreen” or similar sun protection claims on its labeling must qualify the term by describing the cosmetic benefit of the sunscreen ingredient. Accordingly, only those products that contain a sunscreen ingredient solely for a nontherapeutic, nonphysiological use, and which include a labeling statement that accurately describes that use, may be marketed as cosmetic products.

Improper labeling of your product can have severe repercussions as the labeling and composition requirements for cosmetics and drugs are very different. A mislabeled product may be deemed “misbranded” and denied entry into the United States.

If you are concerned about the classification of your product, the regulatory status of your ingredients, or the labeling and that accompany your product, Registrar Corp can assist. Registrar Corp’s Label & Ingredient Review service will research how all these regulations will impact your product and assist you in ensuring compliance as you export to the United States. For more information about food ingredients, labeling and other FDA regulations, please contact Registrar Corp 24/7 at https://www.registrarcorp.com/livehelp or call us at +1-757-224-0177.