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Clinical Trial Summary

The purpose of this study is to determine the 80-Minute Water Resistant SPF of three sunscreen products (ChapStick Active Performance [CAP] UnScented, CAP Herbal Mint Flavour and CAP Mountain Berry Flavour) using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).


Clinical Trial Description

A single-center, randomized, controlled, intra-individual comparison, evaluator-blind, clinical study to determine the 80-minute water resistant SPF of three sunscreen lip balms. Each participant will evaluate two of the three test products, an SPF standard and no treatment. Study treatments will be randomly assigned to 4 test sites delineated on the skin of the participant's back. The two test products will be applied to their allocated test sites prior to the 80-minute water immersion procedure (four 20-minute water immersion periods, each followed by a 15-minute air-drying period); the SPF standard will be applied to its allocated test site on completion of the water immersion procedure. Test sites will be exposed to doses of ultraviolet (UV) radiation and erythemal response evaluated 16-24 hours later. Minimal erythema dose (MED) will be determined for protected and unprotected sites and used to determine the SPF value of each test product. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05124899
Study type Interventional
Source GlaxoSmithKline
Contact US GSK Clinical Trials Call Center
Phone 877-379-3718
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 15, 2021
Completion date December 23, 2021

See also
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