Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products

Exclusion Criteria

• •Participant with a scheduled or planned Covid-19 vaccination during likely dates of study participation.
• •Participant with a history of abnormal response to sunlight/UV radiation.
• •Participant with a history of sensitivity to any ingredient of the test material or skin marker pen, or to latex; or any known sensitivities/allergies, including but not limited to cosmetic/toiletry products and topically applied skin treatment products/drugs.
• •Participant with any significant dermatological condition, such as atopic dermatitis (eczema), psoriasis, skin cancer, melanoma, active dermal lesions, nevi, blemishes or moles, lupus, diabetes, or connective tissue disease, that would increase the risk associated with participation. (Note: presence of non-dysplastic nevi, blemishes, or moles would be acceptable if, in the opinion of the PI, they will neither jeopardize participant safety or compromise study outcomes. A participant with dysplastic nevi should be disqualified.
• •Participant receiving any treatment with medications that would, in the opinion of the PI, confound study outcomes or increase the risk associated with participation, such as systemic or topical corticosteroids, antibiotics, anti-inflammatory drugs, antihistamines, antihypertension medications, or any other photosensitive medications. (Note: The prohibited medication list will be available to site staff for reference during screening)
• •Participant who has used topical or systemic steroids, antihistamines, antibiotics or anti-inflammatory medications within 7 days of Study Day 1 which, in the opinion of the PI, could interfere with study outcomes.
• •Participant who has used/applied any personal care products (for example, lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area within 24 hours of Study Day 1.
• •Participant who is unwilling to cease use of personal care products (for example, lotions, sunscreens, sunless tanners) and/or topical medications in/on the test area for the duration of the study.
• •Participant with any known communicable disease(s) (for example, Human Immunodeficiency Virus \[HIV\], Sexually Transmitted Diseases \[STD's\], Hepatitis B, Hepatitis C, and so on)
• •Participant with skeletal protrusions and/or extreme areas of curvature in the test area.
• •Participant with a medical treatment/vaccination (other than the Covid-19 vaccination) planned during the study, which would make them ineligible, place them at undue risk, or confound the outcome of the study, per the discretion of the PI.
• •Participant who has undergone any surgical procedure in the last 12 months.
• •Participant who has undergone chemical or physical treatment procedures in the test area within the last 12 months.
• •Planned hospitalization during the study.
• •Participant who exceeds a weight limit of 300 pounds due to equipment limitations.
• •Participant with any condition that might confound the study results, increase the risk associated with participation, or interfere with study participation.
• •Female participant who is pregnant, planning to become pregnant during the study, or breastfeeding (self-reported).
• •Participant with any visible sunburn or suntan in test area.
• •Participant with visible sun damage, scarring or tattoos in the test area that would interfere with study participation.
• •Participant with any sun exposure and/or use of an artificial tanning lamp on the test area within 2 months of Study Day 1.
• •Participant who is unwilling to avoid sun exposure and/or cease use of an artificial tanning lamp on the test area for the duration of the study.
• •Participant who has participated in any clinical study involving UV exposure within the last 2 months, or any other type of clinical study within the last 1 month.
• •Participant who is an employee/contractor or immediate family member of the PI, study site or Sponsor.