We co-ordinate clinical testing of dermatology products. These methodologies include: claims substantiation/efficacy, comparative evaluations, safety and in-use studies. Custom protocols are created for special testing needs. We have experience with cosmetics, skin care, personal care, sunscreens, and OTC products.Capabilities (Please note, we do not perform any of these tests, we coordinate these with other labs)
R.I.P.T (repeat insult panel test) in which a product is repeatedly put on a panel of skin/body to make sure it does not irritate.
Per the new FDA Sunscreen regulations of June 2011, all sunscreen products claiming a SPF (sun protection factor) must undergo in-vivo and in-vitro testing to claim broad spectrum protection (UVB/UVA) as well as an SPF. The new monograph also states that sunscreen labels must have specific label claims to educate and protect consumers. To learm more about the FDA’s new sunscreen regulations, click here
- Select a sunscreen ingredient deck
- Understand the label claims – for example spf 15 or spf 30 or spf 50 etc. Are there any water resistant claims? Are there any claims for broad spectrum?
- Make a prototype formulation and show to client
- If needed modify the formula until client is satisfied
- Once there is an agreement on the formulation, we send it for SPF determination testing per FDA regulations.
- If the formula fails the SPF determination testing , we will modify the formulation until the testing reaches the sun protection factor that the formula and label claims and go through steps 3,4 and 5 again
- Once the formula passes, we send it for critical wavelength(in-vitro testing) which allows the sunscreen to claim UVA/UVB protection also known as broad spectrum.
- If the formulation fails, then we modify it until it passes the critical wavelenght ( in-vitro testing) and go through steps 3,4 and 5
- If the formulation passes the critical wavelength (in-vitro testing), we send it for preservatrive challenge test
- Then we send it for RIPT (repeat insult panel test) to make sure it does not irritate
Once the formula passes above testing, we need to do accelerated stability testing for 3 months. Once we commercialize the batch we need to do long term stability testing and validation of the batch