OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: ENSULIZOLE 2.0%, HOMOSALATE 2.0%, OCTINOXATE 7.0%, OXYBENZONE 4.0%.
ACTIVE INGREDIENTS: ENSULIZOLE 2.0%, HOMOSALATE 2.0%, OCTINOXATE 7.0%, OXYBENZONE 4.0%.
WARNINGS: For external use only. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if irritation develops and lasts.
USES: Sun Protection Factor 15. Helps prevent sunburn.
DIRECTIONS: Apply evenly before sun exposure and as needed.
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ensulizole | ACTIVE INGREDIENT | 9YQ9DI1W42 | 1 | |
| Homosalate | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Ensulizole | ACTIVE MOIETY | 9YQ9DI1W42 | 1 | |
| Homosalate | ACTIVE MOIETY | V06SV4M95S | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 13537-261 | 13537-261-61, 13537-261-64, 13537-261-62, 13537-261-65, 13537-261-63 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Ensulizole | 9YQ9DI1W42 | ACTIB |
| Homosalate | V06SV4M95S | ACTIB |
| Octinoxate | 4Y5P7MUD51 | ACTIB |
| Oxybenzone | 95OOS7VE0Y | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 34178401-0ef8-512f-e063-6294a90ab88a | fcd21129-4cb4-4cfb-9865-3cfde69eac0b | 2025-05-01 | Warnings | fcd21129-4cb4-4cfb-9865-3cfde69eac0b |
Adverse event summaries are temporarily unavailable. Other product information remains available.