Scalp Screen meets the new FDA 2010 standard.

On June 14, 2011, the food and drug administration (FDA) announced new testing and labeling requirements for over-the-counter (otc) sunscreen products in the U.S. Scalp Screen meets the new FDA label requirements as well as the standard for broad spectrum sun protection from both UVA and UVB Rays.

The U.S. food and drug administration (FDA) will implement the new requirements for sunscreen products in 2012.  We support the FDA in making it easier for people to choose sun protection for themselves and families by requiring a uniform standard testing and labeling by all sunscreen manufacturers.

Testing requirements specified by the FDA

  • A standard test method for measuring “broad spectrum” protection from UVA and UVB rays has been implemented.
  • A standard test for water resistance has also been approved with a claim of either 40 or 80 minutes maximum.

Labeling Requirements

  • Products that provide UVA/UVB protection and pass testing will be labeled “broad spectrum SPF__”.
  • The term “sunblock” will no longer be used and will be replaced by the word “sunscreen”.
  • The term “waterproof” will be replaced by the words “water resistant” either 40 or 80 minutes.
  • The FDA is proposing a maximum SPF value of 50 and a final decision will be made soon.  We support the limitation of an SPF 50 maximum as we feel that an SPF value of 30 to 50 produces more than enough sun protection.
  • The FDA has yet to approve spray applications due to the uncertainty of how to guarantee the consumer of how much product actually ends up on the skin as opposed to the air (especially aerosol products). However, with so many sprays on the market, we’re sure the FDA will allow them.  They have made several “spray application” labeling recommendations and Scalp Screen labels comply with all of them.
  • All sunscreens will be required to include a standard “Drug Facts” box on all sunscreen labels.

 

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