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New Rules and Regulations for Sunscreen Labels

By: Carl Thornfeldt, MD
Posted: July 27, 2012, from the August 2012 issue of Skin Inc. magazine.
New Rules and Regulations for Sunscreen Labels

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Drug Facts label. The language on the Drug Facts label regarding claims and warnings has been spelled out very specifically for manufacturers. So, for example, a sunscreen that does not offer broad-spectrum protection as clarified in the new rules must state on the back label of the packaging: “Skin cancer/Skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.” However, products that do provide broad-spectrum protection can state: “If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.”

Manufacturers. One objective of the rules released by the FDA were to provide specific guidance in regard to how sunscreens are tested. The guidance provides a common standard for how each sunscreen claim must be tested. The goal is to provide a guarantee to the consumer that products making specific claims will all be following the same standard to reach those claims. Additionally, any products that claim an SPF of greater than 15 must be registered with the FDA as a drug. This directly impacts the manufacturer, as well, because the manufacturer of the product must be formally registered with the FDA as a drug manufacturer.

How does that impact my clients?

The specific nature of the claims on sunscreen packaging will most likely begin a clear trend in determining which sun products rise to the top in the market and which ones will fade away. This will also impact makeup that claims SPF coverage. If makeup products claim higher than an SPF of 15, then the product must be labeled as a sunscreen, include the drug facts claims as mentioned earlier in the article and register as a drug manufacturer.

Make sure that your team members are well-trained to understand each element of change that your clients will see, and then extend the training by posting educational nuggets around your facility and in your treatment rooms. Take the time during one month to ask each client if they know about the changes, and if they would like you to explain them. If you retail sunscreen in your facility, make sure to highlight the packaging changes that are taking place to your clients, and use this opportunity to help them purchase the right sunscreen from your facility. You have a wonderful opportunity to educate your clients about these important changes that will impact them and, ultimately, the health of their skin.

Editor’s note: For more from Dr. Thornfeldt, check out his book The New Ideal in Skin Health: Separating Fact from Fiction, which can be purchased at

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