Sunscreen Regulation - New Measures to Be Introduced by the FDA

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According to a recent announcement by the FDA, their goal is to "...
help consumers know which products offer the best protection from the harmful rays of the sun.
" The regulations will consist of:
  • New testing and labeling standards.
  • A proposed regulation on maximum SPF value on labeling.
  • Requirement to maintain data on safety and effectiveness.
  • Guidance to manufacturers on how to test and label their sunscreen products based on these new requirements.
"Broad Spectrum" protection.
Under these new testing requirements, manufacturers will have to test their sunscreen in order to use the term "Broad Spectrum" protection.
Broad-spectrum protection refers to wavelength.
Basically, ultraviolet rays A & B have different wavelengths and they penetrate the atmosphere and our skin with a different intensity.
  • UVA sun rays make up the vast majority of ultraviolet light because they aren't absorbed by ozone.
    These rays penetrate deeply into the skin and produce the initial effects of sun tanning.
  • UVB are less common and will not penetrate as deeply as UVA rays but yet they are considered the primary cause of sunburns and other serious skin conditions.
  • Skin cancer is the most common form of cancer and UV rays are responsible 90% of the time.
    Every sunburn puts you at a higher risk for skin cancer.
Products that pass the new test:
  • Will be effective for UVA and UVB protection and they can be labeled "Broad Spectrum" and "SPF 15" (or higher).
  • Can indicate that the sunscreen not only protects against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.
Products that do not pass the test (or that have an SPF value between 2 and 14):
  • Will indicate that the sunscreen can only help prevent sunburn.
  • Will be labelled with a "Skin Cancer/Skin Aging Alert" warning.
"Water Resistance" claims Under the new regulations, it will be insufficient to simply claim that the sunscreen / sunblock is "water proof" or "water resistant".
Based on the new tests, the front label will have to indicate how much time (in minutes) a user can expect to get the declared SPF level of protection while swimming or sweating.
Only two times will be permitted: 40 or 80 minutes.
Say Goodbye to "Sunblock" Manufacturers will no longer be able to use the term "Sunblock" or to claim that the sunscreen offers "instant protection".
"SPF 50+" will be the new limit The FDA indicates that they do not have adequate data to demonstrate that sunscreens with SPF values higher than 50 actually provide any additional protection again the sun when compared to products with SPF values of 50.
If the proposed regulation is accepted, sunscreens that have SPF values higher than 50 will have to be labeled as "SPF 50+.
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