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The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor use conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPF 50 Y65 110 | Experimental | All subjects received baseline skin evaluation and 1 day of sun exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPF 50 Y65 110 (BAY 987516) | Drug | Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout. |
| Measure | Description | Time Frame |
|---|---|---|
| Dermatologist´s subjective and objective assessments of potential Adverse events | • "product related," • "likely product related," • "unlikely product related, or "not product related. | 2 days |
| Final Skin Evaluation | • Score 0 (no response): Normal skin. No visible response or erythema. up to Score 3 (severe response): A well demarcated area of very intense or "beet" red erythema or an area of the skin affected by significant edema, papules, and/or vesicles. Usually symptomatic and may require therapeutic intervention. | 2 days |
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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 |
|---|---|---|---|---|---|---|
| St. Petersburg | Florida | 33714 | United States |
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