TABLE OF CONTENTS:
Purpose of Study:
Measure the static sun protection factor (SPF) of Skinvisible®'s Invisicare Over-the-Counter (OTC) SPF 30 sunscreen formulation on 21 qualified human volunteers with skin types I, II, and III under "Very Water Resistant" conditions, in accordance with the FDA Final MONOGRAPH CFR 21 Part 352: Sunscreen Drug Products for Over-the-Counter Human use.
SUNCARE RESEARCH LABORATORIES, LLC
In Vivo Protocol: Human Subjects
On day one of the study, each subject received a series of UV doses to an unprotected site on the mid-back. On the second day, the minimal erythema dose (MED) was determined as the lowest UV dose which produced mild erythema reaching the borders of the exposed site. Next, 100 mg of Invisicare SPF 30 sunscreen formulation was applied to a 50 cm2 area of the mid-back. After a 15-minute drying period, subjects sat in a tub with moving water for 4 periods of 20 minutes of water immersion, separated by 20 minutes out of the water, totaling 80 minutes of accumulative water immersion.
After drying for 15 minutes, 100 mg of the 8% homosalate standard sunscreen, which had an expected SPF of 4.47, was applied to a 50 cm2 area adjacent to the test product, then UV doses as described in the protocol were administered to the respective sunscreen-protected areas. A series of UV doses was also administered to a second unprotected site.
On the third day the MED was determined for the sunscreen-protected sites and the unprotected site and the SPF's of each sunscreen were calculated as the ratio of the MED's for each protected site to the MED for the unprotected site. These results were used to determine the "Very Water Resistant" SPF of Invisicare SPF 30 sunscreen formulation according to the FDA Sunscreen Monograph.
Figure 1: Summary of Static SPF Test Results
- 21 subjects completed the study including 12 men and 9 women.
- Subjects included 8 with skin type I, 7 with skin type II, and 6 with skin type III.
- The mean SPF was 31.4 after 80 minutes of water immersion with a 95% confidence interval allowing the product to be labeled as 'Very Water Resistant' SPF 30.
Note: This document is an excerpt taken from the final report SRL2000-052 (CSRI #00-224) issued by Suncare Research Laboratories, LLC.