Sign in

New Rules and Regulations for Sunscreen Labels

Carl Thornfeldt, MD August 2012 issue of Skin Inc. magazine
New Rules and Regulations for Sunscreen Labels

Get the Skinny! This is just part of the article. Want the complete story, plus a host of other cutting-edge articles to make your job easier? Sign up!

For years, the U.S. Food and Drug Administration (FDA) has been in a holding pattern with a variety of proposed regulation changes regarding how sunscreens are labeled and marketed in the United States. Finally, last year, the FDA came to a consensus on many of the parameters surrounding sunscreens and provided formal rules that can now be found in the Federal Register (Vol 76, No 117/Friday, June 17, 2011). Some of the changes that have gone into effect only impact sunscreen manufacturers; however, some of the changes you and your clients will begin to see on sunscreen packaging this summer. This article will give you the tools you need to educate your clients in order to help them understand the changes and make good decisions about the products they purchase.

Why did changes need to occur?

The FDA considers sunscreens to be over-the-counter (OTC) drugs. As of the new deadline of Dec. 18, 2012, (this was originally June 18, 2012) new rules will go into effect for the labeling of any product claiming sun protection of SPF 15 and higher. The FDA puts great care into its introductory remarks in the Federal Register to describe all the reasoning that went into how the decisions were made. The basic concept is that the FDA wanted to help simplify the message that consumers were receiving in the marketplace. The consensus was that consumers did not really understand some of the claims being made and, therefore, were not making good decisions. Because the improper use of sunscreen can potentially lead to skin cancer, the FDA wanted to make sure the consumer clearly understood certain concepts regarding sunscreens and skin care.

What is changing?

Broad-spectrum. UVA rays are a major cause of skin cancer due to immunosuppression, as well as abnormal pigmentation and visible skin aging—especially wrinkles. On the other hand, UVB rays are the rays that burn the skin, activating nonmelanoma skin cancer. It is important that both are blocked. If a product provides UVA protection at 370 nanometers (nm) or more, as well as UVB protection, then it can claim to offer broad-spectrum protection. Otherwise, no UVA protection can be claimed at all. If a product can prove broad-spectrum, then it must be labeled as such on the front of the packaging, along with the SPF value.

Want the rest of the story? Simply sign up. It’s easy. Plus, it only takes 1 minute and it’s free!



Welcome to the new!

Delivering the best information on the spa, skin care and wellness industry is our passion, and we’ve worked hard to design a powerful new website that incorporates cutting-edge technology to bring you:

  • Mobile-friendly Design
  • Integrated Sample Request
  • Refreshed Look and Feel
  • Dynamic Content
  • Free Registration

Mobile-friendly Design

Providing a unified experience from mobile to desktop, responsive design allows you to access Skin Inc. content from any device, whether you’re in the treatment room, at home or on the go!

Integrated Sample Request

Visit Featured Product pages to quickly and easily identify new suppliers and request product samples and information.

Dynamic Content

Articles are now linked with relevant products so you can find the products and treatments you need to provide the best results for your clients.

Free Registration

Create your user account to gain unlimited access to Skin Inc.’s unparalleled content.

Enjoy the New!

Thank you for joining the Skin Inc. community of passionate skin care professionals. We look forward to providing you the best information to enhance your career!