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To assess the safety of a sunscreen product when used outdoor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY987518 | Experimental | Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. |
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| Sunscreen control | Active Comparator | Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY987518 | Drug | Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. Formulation: V27-104 |
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| Measure | Description | Time Frame |
|---|---|---|
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 | After approximately three hours direct sun-exposure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Petersburg | Florida | 33714 | United States |
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| Sunscreen Lotion (U77-030 Control) | Drug | Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. |
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