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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. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Safety of a Sunscreen product | Experimental | Sunscreen product safety evaluation under supervised out-door conditions on sport users. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY 987519, SPF 50, Y51-002 | Drug | Sufficient amount to cover all exposed skin liberally two times - approximately 240 min. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Erythema as graded on a 5 point scale. | approximately 24 hours | |
| Evaluation of AEs, including eye stinging | Reported as product related or likely product related by the investigator or trained designee | approximately 24 hours |
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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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| BAY 987519, SPF 50, P04-147 | Drug | Sufficient amount to cover all exposed skin liberally two times - approximately 240 min. |
|