The Skin Cancer Foundation’s Response to the Release of the Final FDA Monograph

The Skin Cancer Foundation applauds the FDA for issuing its Final Sunscreen Monograph. According to the FDA, sunscreen ingredients are safe, and the benefit of regular sunscreen use far outweigh any potential risks.

Sun protection is an important public health issue, and sunscreen is an integral part of a comprehensive sun protection regimen that also includes seeking shade and wearing protective clothing, including sunglasses. Although science and technology have advanced over the past several years to dramatically improve the efficacy of sunscreens, there has long been a need to update the governmental regulations associated with them – particularly in the areas of UVA protection and product labeling.

This announcement is a significant advancement for the FDA, which brings awareness to and acknowledges the importance of UVA protection in the prevention of skin cancer. We hope that these new FDA rules, along with the recently updated standards set by The Skin Cancer Foundation’s Seal of Recommendation will enable consumers to choose sunscreens wisely.

- Steven Wang, MD, Committee Member, The Skin Cancer Foundation’s Photobiology Committee; Director of Dermatologic Surgery and Dermatology at Memorial Sloan-Kettering Cancer Center at Basking Ridge, NJ.


Here are the main points in the FDA’s new sunscreen rules:

•Sunscreens may be labeled “broad-spectrum” if they provide protection against ultraviolet A (UVA) and ultraviolet B (UVB) radiation.
•Only broad-spectrum sunscreens with a Sun Protection Factor (SPF) of 15 or higher can state that they protect again skin cancer if used as directed with other sun protection measures.


•Sunscreens with an SPF of 2-14 will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.


•The terms “sunblock”, “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.


•A sunscreen may claim to be “water resistant”; however, the product must specify if it offers 40 minutes or 80 minutes of protection while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.


•Sunscreens cannot claim to provide sun protection for more than two hours without reapplication.


•Sunscreen manufacturers will have one year to comply with the FDA ruling; smaller companies will have two years.


•The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.
•The FDA reiterated that sunscreen alone is not enough, and should be used in conjunction with a complete sun protection regimen, including seeking shade, wearing long pants, long-sleeved shirts, hats and sunglasses.