The Skin Cancer Foundation Introduces New Criteria for Seal of Recommendation

New York, NY (January 27, 2011) - The Skin Cancer Foundation is implementing a new set of standards for its Seal of Recommendation program, including the introduction of ultraviolet A (UVA) protection requirements for sunscreens and categorization of sunscreens based on intended use.

"This is a watershed moment for an awareness program that is more than thirty years old," said Perry Robins, MD, president, The Skin Cancer Foundation. "Our goal, now more than ever, is for the Seal to help consumers easily identify safe and effective sunscreens amid varying claims and labeling practices."

As the leader in skin cancer education, The Skin Cancer Foundation is the only organization to set rigorous standings and review all the safety and efficacy data before a product is awarded the Seal. This program enables the Foundation to educate consumers when they are making important decisions about sun protection which directly affects the health of their skin.

Over the past few decades, there have been significant innovations in sunscreens, which the new Seal of Recommendation will incorporate. The updated Seal will require scientific verification of the sunscreen's UVA protection in addition to the existing UVB requirement. Additionally, there will now be two Seals of Recommendation - one called "Daily Use" and one called "Active." Each Seal has different requirements.

"Daily Use" products are intended to protect consumers from incidental sun exposure that occurs over short periods of time during activities such as shopping and short drives. Examples might include daily moisturizers, cosmetics, foundations, eye creams and lip products.

Requirements:

  • SPF of 15 or higher
  • Validation of the SPF number by testing on 20 subjects
  • A critical wavelength of 370 or Persistent Pigment Darkening (PPD) of 5, as tested on 10 subjects
  • Acceptable results for phototoxic reactions and contact irritancy testing on 20 subjects
  • Proof of photostability
  • Substantiation for any claims that a sunscreen is water- or sweat-resistant

"Active" products are designed to protect consumers from extended sun exposure and during recreational activities such as outdoor sports, picnics and pool parties. Examples might include higher SPF products, sport sunscreens and baby products.

Requirements:

  • SPF of 30 or higher
  • Validation of the SPF number by testing on 20 subjects
  • A critical wavelength of 370 or Persistent Pigment Darkening (PPD) of 10, as tested on 10 subjects
  • Acceptable results for phototoxic reactions and contact irritancy testing on 20 subjects
  • Proof of photostability
  • Proof of water resistance

"After extensive planning and market research, we are implementing a program that requires stringent sun protection standards and simplifies product labeling," said Warwick Morison, MD, Chairman of the Foundation's Photobiology Committee. "Selecting effective sun protection products is a matter of public health, and this is, above all, a consumer education program."

The Foundation will begin accepting applications for the new Seal in July 2010 and require full compliance by all current Seal holders by May 2012.


The FDA Sunscreen Monograph

According to sources at the FDA, the agency's pending sunscreen monograph will be released in early 2011. In addition to addressing labeling issues and possibly capping SPF at 50+, the proposed monograph will also include a UVA protection rating system. Once the proposal has been released, there will be a 90-day commentary period before the final ruling is issued. Sunscreen manufacturers will have 18 months to comply once the monograph is finalized.

About the Seal of Recommendation

In 1979, sunscreen SPF (sun protection factor) labels indicating protection from the sun's ultraviolet B (UVB) rays had just been introduced and the highest SPF number was 12. Few people knew about the importance of sun protection. The Skin Cancer Foundation was the first organization to recognize that a change in behavior about sun exposure and increased awareness of the importance of protection was needed. That year, as part of a nationwide public awareness campaign, the Foundation established its Seal of Recommendation program, which has since become a respected standard for the safety and efficacy of ultraviolet (UV) protection products.

The Foundation initially created the Seal program for SPF 15+ sunscreens. As sun protection technology has advanced, the Foundation has expanded the program to include products such as sunglasses; sun-protective clothing; umbrellas and awnings; UV window film; UV laundry additives; and sunroof materials. Currently, more than 850 products worldwide carry the Seal of Recommendation.

Every product submitted for the Seal of Recommendation is rigorously reviewed by an independent committee of renowned photobiologists - experts in the study of the interaction of ultraviolet radiation and the skin. The members of The Skin Cancer Foundation's Photobiology Committee are: Chairman Warwick Morison, MD, professor of Dermatology, John Hopkins Medical School; Henry W. Lim, MD, Dr. Lim is the Chairman and Clarence S. Livingood Chair of the Department of Dermatology at Henry Ford Hospital in Detroit; John Epstein, MD, clinical professor of Dermatology, University of California at San Francisco; Heidi Jacobe, MD, assistant professor, Dermatology, University of Texas Southwestern Medical Center at Dallas, and Steven Q. Wang, MD, director, Dermatology Service, Memorial Sloan Kettering Cancer Center, New Jersey.

The Foundation initially created the Seal program for SPF 15+ sunscreens. As sun protection technology has advanced, the Foundation has expanded the program to include products such as sunglasses; sun-protective clothing; umbrellas and awnings; UV window film; UV laundry additives; and sunroof materials. Currently, more than 850 products worldwide carry the Seal of Recommendation.

Every product submitted for the Seal of Recommendation is rigorously reviewed by an independent committee of renowned photobiologists - experts in the study of the interaction of ultraviolet radiation and the skin. The members of The Skin Cancer Foundation's Photobiology Committee are: Chairman Warwick Morison, MD, professor of Dermatology, John Hopkins Medical School; Henry W. Lim, MD,

Dr. Lim is the Chairman and Clarence S. Livingood Chair of the Department of Dermatology at Henry Ford Hospital in Detroit; John Epstein, MD, clinical professor of Dermatology, University of California at San Francisco; Heidi Jacobe, MD, assistant professor, Dermatology, University of Texas Southwestern Medical Center at Dallas, and Steven Q. Wang, MD, director, Dermatology Service, Memorial Sloan Kettering Cancer Center, New Jersey.

About The Skin Cancer Foundation

The Skin Cancer Foundation is the only global organization solely devoted to the prevention, detection and treatment of skin cancer. The mission of the Foundation is to decrease the incidence of skin cancer through public and professional education and research. For more information, visit www.SkinCancer.org


*There are a number of test methods that can be used to evaluate the UVA protective level of a sunscreen product. Two of the most common methods are the Critical Wavelength test and Persistent Pigment Darkening (PPD).

Critical Wavelength is a laboratory test method using specially formulated tape that measures UV transmission with and without sunscreen. In this method, the absorption spectrum of the sunscreen is measured against wavelength. The wavelength where 90 percent of absorption occurs is defined as the critical wavelength. The more potent the UVA protection, the longer the critical wavelength.

The PPD in vivo method is modeled after the SPF test. Human subjects are exposed to UVA wavelengths (320 to 400 nanometers) both with and without sunscreen. The appearance of pigment darkening of the exposed skin between 2 to 24 hrs after exposure is used as a biological endpoint.