Storage and handling
Other Information: Protect the product in this container from excessive heat and direct sun.
Other Information: Protect the product in this container from excessive heat and direct sun.
Active Ingredient:
OXYBENZONE: 6.0%
Octyl Methoxycinnamate: 7.5%
Purpose:
Sunscreen
Uses: Help prevent sunburn
Warning:
For external use only
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer or early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin aging.
When using this product:
Keep out of eyes. Rinse with water to remove.
Stop Use and Ask a Doctor if:
Rash occurs
Keep Out of Reach of Children
Directions:
Other Information:
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient:
Paraffinium Liquidum (Mineral Oil), Polyisobutene, Ethylhexyl Palmitate, Aspartame, Silica, Quartz, Tin Oxide.
May contain:
Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (77891), Red 6 Lake (CI 15851), Red 7 Lake (CI 15850), Yellow 5 Lake (CI 19140), Red 28 Lake (CI 45410), Red 36 Lake (CI 12085)
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-105-51 | 2019-12-26 | C162847 | 48780-1 | 9855e2a2-48ff-60a7-e053-dbdaa90a05bd | edcec7df-5fed-4ec8-8bc1-32b6508c71c7 |
| 76354-105-51 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-48ff-60a7-e053-dbdaa90a05bd | edcec7df-5fed-4ec8-8bc1-32b6508c71c7 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 3 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 3 | |
| POLYISOBUTYLENE (1100000 MW) | INACTIVE INGREDIENT | FLT10CH37X | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-105 | 76354-105-01, 76354-105-51 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| POLYISOBUTYLENE (1100000 MW) | FLT10CH37X | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MICA | V8A1AW0880 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| FERRIC OXIDE RED | 1K09F3G675 | IACT |
| FERRIC OXIDE YELLOW | EX438O2MRT | IACT |
| FERROSOFERRIC OXIDE | XM0M87F357 | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SHAMPOO / TOPICAL | 0.03 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SYSTEM / TOPICAL | 21 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ENEMA / RECTAL | 0.02 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, COATED / ORAL | 4.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SPRAY / TOPICAL | 0.8 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET / ORAL | 7.5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / TOPICAL | 0.1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | SUPPOSITORY / VAGINAL | 1464.9 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION, EXTENDED RELEASE / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, DELAYED RELEASE / ORAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LIQUID / ORAL | 162 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | SYSTEM / TRANSDERMAL | 170 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, DELAYED RELEASE / ORAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, DELAYED RELEASE / ORAL | 37 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE / ORAL | 11 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET / ORAL | 1.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / TOPICAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v |
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 |
|---|---|---|---|---|---|---|
| 3b5351fa-0d8f-4983-825c-92ffb36854e7 | edcec7df-5fed-4ec8-8bc1-32b6508c71c7 | 2014-04-08 | Warnings | edcec7df-5fed-4ec8-8bc1-32b6508c71c7 |
Adverse event summaries are temporarily unavailable. Other product information remains available.