OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: 7.5% OCTINOXATE, 1.0% TITANIUM DIOXIDE
ACTIVE INGREDIENTS: 7.5% OCTINOXATE, 1.0% TITANIUM DIOXIDE
INDICATIONS: PROVIDES BROAD SPECTRUM PROTECTION FROM SUN'S DAMAGING RAYS.
USAGE: SHAKE WELL BEFORE USE. APPLY PRIOR TO SUN EXPOSURE
WARNING:KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 64141-001-01 | 2025-04-17 | C162847 | 48780-1 | 956f9ecf-ced9-621f-e053-dbdaa90a74ad | 03b11d23-950e-40db-a553-3ab4aa17a246 |
| 64141-001-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-ced9-621f-e053-dbdaa90a74ad | 03b11d23-950e-40db-a553-3ab4aa17a246 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 64141-001 | 64141-001-02, 64141-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| b0c69e95-46d6-46eb-b016-01d80c7c53d1 | 03b11d23-950e-40db-a553-3ab4aa17a246 | 2025-04-11 | Warnings | 03b11d23-950e-40db-a553-3ab4aa17a246 |
Adverse event summaries are temporarily unavailable. Other product information remains available.