Storage and handling
Other Information Store at room temperature 20-25 C (77-86F)
Other Information Store at room temperature 20-25 C (77-86F)
Active Ingredient:
Benzophenone-3: 5%
Ethylhexyl Methoxycinnamate: 7.5%
Purpose:
Sunscreen
Uses:
Helps prevent sunburn
Warning:
For external use only
Skin Cancer/Skin Aging Alert:
Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer or skin gaing
When Using This Product:
Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If:
Rash or irritation develops and lasts
Keep Out Of Reach Of Children:
If swallowed get medical help or contact a Poison Control Center immediately
Directions:
Apply liberally as often as needed before sun exposure.
Reapply as needed or after swimming or towel drying
Inactive Ingredient:
Paraffinium Liquidum (Mineral Oil), hydrogenated Polyisobutene, Polyethylene Wax, Ceresine Wax, Copernicia Cerifera (Carnauba) Wax, Microcrystalline Wax, Mentha Piperita (Peppermint) Oil, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben.
labe
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 76354-012-01 | 2019-12-24 | C162847 | 48780-1 | 97449f38-b99f-f6ea-e053-dbdaa90aa703 | Drug Fact |
| 76354-012-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-b99f-f6ea-e053-dbdaa90aa703 | Drug Fact |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| BUTYLPARABEN | INACTIVE INGREDIENT | 3QPI1U3FV8 | 2 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 2 | |
| ETHYLPARABEN | INACTIVE INGREDIENT | 14255EXE39 | 2 | |
| LIGHT MINERAL OIL | INACTIVE INGREDIENT | N6K5787QVP | 2 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 2 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 2 | |
| PEPPERMINT OIL | INACTIVE INGREDIENT | AV092KU4JH | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYISOBUTYLENE (1200000 MW) | INACTIVE INGREDIENT | FLT10CH37X | 2 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 76354-012 | 76354-012-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| POLYISOBUTYLENE (1200000 MW) | FLT10CH37X | IACT |
| CARNAUBA WAX | R12CBM0EIZ | IACT |
| MICROCRYSTALLINE WAX | XOF597Q3KY | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| PEPPERMINT OIL | AV092KU4JH | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| ETHYLPARABEN | 14255EXE39 | IACT |
| BUTYLPARABEN | 3QPI1U3FV8 | 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 |
|---|---|---|---|---|---|---|
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM, AUGMENTED / TOPICAL | 25 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | AEROSOL, FOAM / TOPICAL | 0.16 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OINTMENT / TOPICAL | 1335 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LIQUID / ORAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAMUSCULAR | 0.02 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / OPHTHALMIC | 0.05 %w/w | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | OIL / TOPICAL | 2509 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | TABLET / ORAL | 28 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / ORAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | FILM / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAMUSCULAR | 95 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 mg | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | CREAM / TOPICAL | 456 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, EXTENDED RELEASE / ORAL | 0.17 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRAVENOUS | 6 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | ELIXIR / ORAL | 200 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / RECTAL | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / OPHTHALMIC | 0.02 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / INTRAVENOUS | 45 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / RECTAL | 271 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IONTOPHORESIS | 0.1 %w/v | ||
| ETHYLPARABEN | ETHYLPARABEN | 14255EXE39 | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / AURICULAR (OTIC) | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / NASAL | 140 mg | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | TABLET / ORAL | NA | ||
| LIGHT MINERAL OIL | LIGHT MINERAL OIL | N6K5787QVP | TABLET, FILM COATED / ORAL | 2.49 mg | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | SUSPENSION / ORAL | 100 mg/1ml | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CAPSULE, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / AURICULAR (OTIC) | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| PEPPERMINT OIL | PEPPERMINT OIL | AV092KU4JH | CAPSULE / ORAL | 60 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | TABLET, FILM COATED / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| BUTYLPARABEN | BUTYLPARABEN | 3QPI1U3FV8 | DROPS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| 394af0f7-6366-4ca1-aee3-3f85f47f0bc2 | 6aeda5bf-0750-49aa-8f7d-054974848f2e | 2012-04-18 | Warnings | 6aeda5bf-0750-49aa-8f7d-054974848f2e |
Adverse event summaries are temporarily unavailable. Other product information remains available.