Sun Protection Factor Assay (SPF Assay 207/2016)

Not Applicable

Completed

Brief Summary: To evaluate the Sun Protection Factor efficacy on human skin.

Recruitment & Eligibility

Inclusion Criteria

Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
Male and female.
Aged between 18-70 years old.
Good health as determined from the HRL SHF (Subject History Form).
Signed and dated Informed Consent Form.
Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria

Subjects on test at any other research laboratory or clinic.
Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
Pre-existing other medical conditions (e.g. adult asthma, diabetes).
Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
Treatment with antibiotics within two weeks prior to initiation of the test.
Chronic medication which could affect the results of the study.
Known pregnant or nursing women.

Arm && Interventions

Group	Intervention	Description
BAY987521	BAY987521	Each test site area is divided into test sub site areas that are approximately at least 0.5 cm\2. The application of test material is 2 mg/cm\2. Thus, each 50 cm\2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\2 test application.

Primary Outcome Measures

Name	Time	Method
Minimal Erythema Dose (MED)	Up to 15 minutes
Minimal Persistent Pigment Darkening Dose (MPPD)	Up to 15 minutes

Secondary Outcome Measures

Name	Time	Method

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