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Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF evaluation | Experimental | Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were considered for SPF testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 987517 | Drug | Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327 | 16-24 h post exposure |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union | New Jersey | 07083 | United States |
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| SPF 15 Control | Drug | Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application. |
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