Conditions: Sun Protection
Keywords: Sunscreens
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: yes

Brief summary:
Study to determine the sunscreen protection factor (SPF) and ultraviolet A protection factor (PFA) of 2 sunscreen products containing the combination of zinc oxide and avobenzone with and without ensulizole.

Detailed description:

Arms:
arm 1: Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet B radiation \[UVB\] and UVA). arm 2: Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.

Interventions: intervention 1: Sunscreen Test Code: V53-028 intervention 2: Sunscreen Test Code: V53-030 intervention 3: Standard SPF 4 Sunscreen
Intervention descriptions: intervention 1: Sunscreen formula containing 15% Zinc Oxide, 3% Avobenzone, and 1% Ensulizole intervention 2: Sunscreen formula containing 15% Zinc Oxide and 3% Avobenzone intervention 3: 8% Homosalate Standard SPF 4 Sunscreen

Protocol document: