Sun Protection Factor (SPF) Determination of Two Sunscreen-Containing Lip Balms

Not Applicable

Completed

Interventions: Drug: ChapStick Moisturizer, Classic Flavor
Drug: ChapStick Moisturizer, Strawberry Flavor

Brief Summary: The aim of this study is to determine the SPF of two test materials ChapStick Moisturizer, Classic Flavor and ChapStick Moisturizer, Strawberry Flavor using the methodology described in the International Standard Test Method. This static methodology also meets the requirements of the Australia/New Zealand standard.

Detailed Description: A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of two ChapStick sunscreen-containing lip balms as per ISO 24444:2010. For each participant, 4 test sites will have a random assignment number for up to two test materials, control standard, and minimal erythemal dose of unprotected skin (MEDu), with at least 3 of the test sites being utilized for application. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
ChapStick Moisturizer, Classic Flavor	ChapStick Moisturizer, Classic Flavor	This arm will include all the test sites on the participants back where ChapStick Classic Moisturizer (ANZ) will be applied.
ChapStick Moisturizer, Strawberry Flavor	ChapStick Moisturizer, Strawberry Flavor	This arm will include all the test sites on the participants back where ChapStick Strawberry Moisturizer (ANZ) will be applied.

Primary Outcome Measures

Name	Time	Method
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values	Up to 24 hours post UVR exposure	Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hrs after exposure to UVR. SPFi = MEDp/MEDu. No inferential statistical analysis was performed for this outcome. The MED is defined as the lowest dose of UVR that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UVR exposure. The UVR exposure should be increased in geometric progression with 25% dose increment in relation to the expected SPF values. All individual SPF values were converted arithmetically to calculate SPF of test material (or control standard).

Secondary Outcome Measures