Indications and uses
USES: Helps prevent sunburn. DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.
USES: Helps prevent sunburn. DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.
USES: Helps prevent sunburn. DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.
Please store at room temperature.
OCTINOXATE 3%; TITANIUM DIOXIDE 5.09%
USES: Helps prevent sunburn.
DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.
Please store at room temperature.
WARNINGS: FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION OR RASH PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68570-704-01 | 2025-01-03 | C162847 | 48780-1 | 956f9ecf-c249-621f-e053-dbdaa90a74ad | Drug Facts |
| 68570-704-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c249-621f-e053-dbdaa90a74ad | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| Titanium Dioxide | ACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| Titanium Dioxide | ACTIVE MOIETY | 15FIX9V2JP | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68570-704 | 68570-704-01 |
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 |
|---|---|---|---|---|---|---|
| 9cfa682c-094b-46e0-aeb8-1332afb699ab | f7528b37-9551-4eac-8271-c1c1c4efa7b8 | 2025-01-02 | Warnings | f7528b37-9551-4eac-8271-c1c1c4efa7b8 |
Adverse event summaries are temporarily unavailable. Other product information remains available.