Indications and uses
Helps prevent sunburn.If used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun.
Helps prevent sunburn.If used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun.
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including: Limit time in the sun, especially from 10 a.m. – 2 p.m. Wear long-slee...
Octinoxate 7.0%
Octisalate 4.0%
Titanium Dioxide 4.0%
Sunscreen
Helps prevent sunburn.If used as directed with other sun protection measures (see Directions). Decreases the risk of skin cancer and early skin aging caused by the sun.
For external use only
on damaged or broken skin
keep out of eyes. Rinse with water to remove.
if rash occurs
If product is swallowed, get medical help or contact a Poison Control Center right away
Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other skin protection measures including:
Children under 6 months: Ask a doctor
ALUMINA, BUTYLENE GLYCOL, CALCIUM CARBONATE, CAPRYLYL GLYCOL, CETYL PEG/PPG 10/1 DIMETHICONE, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, GLYCERIN, GLYCERYL BEHENATE, GLYCERYL DIBEHENATE, GOSSYPIUM HERBACEUM(COTTON), HEXYL LAURATE, HEXYLENE GLYCOL, HYDROGENATED POLYISOBUTENE, LYCIUM BARBARUM FRUIT EXTRACT, MAGNESIUM SULFATE, MICA, MICROCRYSTALLINE WAX, PEG-10 DIMETHICONE, PENTAERYTHRITYL, TETRASISOSTERATE, PHENOXYETHANOL, POLYETHYLACRYLATE, POLYGLYCERYL-3 BEESWAX, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-4 ISOSTEARATE, POTASSIUM SORBATE, PROPYLENE CARBONATE, QUATERNIUM-90 BENTONITE, SILICA, SILICA DIMETHYL SILYLATE, SODIUM BENZOATE, SODIUM CHLORIDE, SODIUM HYALURONATE, STEARIC ACID, TREBEHENIN, TRIETHOXYLCAPRYLYLSILANE, WATER. MAY CONTAIN (+/-): IRON OXIDES (CI77491), IRON OXIDES (CI77492), IRON OXIDES (CI77499), TITANIUM DIOXIDE (CI77891).
Protect this product from excessive heat and direct sun.
Call toll free 855-201-4529
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 4 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 4 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 4 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 4 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 4 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 4 | |
| 1,3-BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 4 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 4 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 4 | |
| CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) | INACTIVE INGREDIENT | V2W71V8T0X | 4 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 4 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 4 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 4 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | 4 | |
| GOSSYPIUM HERBACEUM WHOLE | INACTIVE INGREDIENT | 9DK7DJK0D6 | 4 | |
| HEXYL LAURATE | INACTIVE INGREDIENT | 4CG9F9W01Q | 4 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 4 | |
| HYDROGENATED POLYBUTENE (1300 MW) | INACTIVE INGREDIENT | 7D1YQ9Y5EZ | 4 | |
| LYCIUM BARBARUM FRUIT | INACTIVE INGREDIENT | 930626MWDL | 4 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | 4 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 4 | |
| MICROCRYSTALLINE WAX | INACTIVE INGREDIENT | XOF597Q3KY | 4 | |
| PEG-10 DIMETHICONE (600 CST) | INACTIVE INGREDIENT | 8PR7V1SVM0 | 4 | |
| PENTAERYTHRITYL TETRAISOSTEARATE | INACTIVE INGREDIENT | 9D7IK5483F | 4 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 4 | |
| POLYGLYCERYL-3 RICINOLEATE | INACTIVE INGREDIENT | MZQ63P0N0W | 4 | |
| POLYGLYCERYL-4 ISOSTEARATE | INACTIVE INGREDIENT | 820DPX33S7 | 4 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 4 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 4 | |
| SILICA DIMETHYL SILYLATE | INACTIVE INGREDIENT | EU2PSP0G0W | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 4 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 4 | |
| TRIBEHENIN | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 4 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 42627-255 | 42627-255-01, 42627-255-02 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION / RECTAL | 6.67 %w/v | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | INJECTION / INTRAVENOUS | 864 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, FILM COATED / ORAL | 300 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SILICA DIMETHYL SILYLATE | SILICA DIMETHYL SILYLATE | EU2PSP0G0W | CREAM / VAGINAL | 50 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYSTEM / TOPICAL | 2 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | GRANULE, FOR SUSPENSION / ORAL | 11 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, EXTENDED RELEASE / ORAL | 200 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED PELLETS / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | CREAM / TOPICAL | 385 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| MICROCRYSTALLINE WAX | MICROCRYSTALLINE WAX | XOF597Q3KY | CREAM / VAGINAL | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | OINTMENT / TOPICAL | 12 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, COATED / ORAL | 0.2 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | POWDER, FOR SOLUTION / ORAL | 98 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | TABLET, COATED / ORAL | 19 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | POWDER, FOR SUSPENSION / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | EMULSION / ORAL | NA | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | GUM, CHEWING / BUCCAL | 3492 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| GLYCERYL DIBEHENATE | GLYCERYL DIBEHENATE | R8WTH25YS2 | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | SOLUTION / RESPIRATORY (INHALATION) | 4.02 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | LOTION / TOPICAL | 0.2 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | IMPLANT / SUBCUTANEOUS | 1.04 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, COATED / ORAL | 64.8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg |
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 |
|---|---|---|---|---|---|---|
| ec1ff2fc-88ca-3feb-e053-2a95a90a18ac | acea3093-2d2c-4467-adb6-6f7ccd2ae6a4 | 2022-10-31 | Warnings | ec1ff2fc-88ca-3feb-e053-2a95a90a18ac acea3093-2d2c-4467-adb6-6f7ccd2ae6a4 |
Adverse event summaries are temporarily unavailable. Other product information remains available.