Indications and uses
Helps prevent sunburn
Helps prevent sunburn
For sunscreen use: Apply liberally 15 minutes before sun exposure. Reapply at least every two hours. 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 value of 15 or higher and other sun protection measures including: Limit ti...
Octinoxate 5.49%
Titanium Dioxide 2.19%
sunscreen
on damaged or broken skin.
keep out of eyes. Rinse with water to remove.
if rash occurs.
If swallowed, get medical help or contact a Poison Control Center right away.
For sunscreen use:
AQUA (WATER) • CYCLOPENTASILOXANE • GLYCERIN • ISODODECANE • PENTYLENE GLYCOL • ALCOHOL • DIMETHICONE • PEG-10 DIMETHICONE • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE • SORBITAN SESQUIOLEATE • DISTEARDIMONIUM HECTORITE • PHENOXYETHANOL • CHONDRUS CRISPUS (CARRAGEENAN) • ACRYLATES/DIMETHICONE COPOLYMER • SILICA • OLYMETHYLSILSESQUIOXANE
• PARFUM (FRAGRANCE) • ALUMINUM HYDROXIDE • SODIUM MYRISTOYL GLUTAMATE • STEARIC ACID • SILICA SILYLATE • PROPYLENE CARBONATE • TOCOPHERYL ACETATE • ALPHA-ISOMETHYL IONONE • BENZYL BENZOATE • SYNTHETIC FLUORPHLOGOPITE • BHT • LINALOOL •BENZYL ALCOHOL • DIAMOND POWDER • LIMONENE • AMYL CINNAMAL • TOCOPHEROL • BUTYLPHENYL METHYLPROPIONAL • GERANIOL • [MAY CONTAIN : CI 77891 (TITANIUM DIOXIDE) • CI 77491 (IRON OXIDES) • CI 77492 (IRON OXIDES) • CI 77499 (IRON OXIDES)] (08890)
In USA: 19 East, 57th Street, New York, NY 10022
| 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 | |
| .ALPHA.-AMYLCINNAMALDEHYDE | INACTIVE INGREDIENT | WC51CA3418 | 3 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 3 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 3 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 3 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | 3 | |
| BENZYL BENZOATE | INACTIVE INGREDIENT | N863NB338G | 3 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 3 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 3 | |
| BUTYLPHENYL METHYLPROPIONAL | INACTIVE INGREDIENT | T7540GJV69 | 3 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | 3 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 3 | |
| DIAMOND | INACTIVE INGREDIENT | 6GRV67N0U2 | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 3 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| GERANIOL | INACTIVE INGREDIENT | L837108USY | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 3 | |
| ISOMETHYL-.ALPHA.-IONONE | INACTIVE INGREDIENT | 9XP4LC555B | 3 | |
| LINALOOL, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 3 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 3 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| PROPYLENE CARBONATE | INACTIVE INGREDIENT | 8D08K3S51E | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SODIUM MYRISTOYL GLUTAMATE | INACTIVE INGREDIENT | AYU7QD893W | 3 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49817-0084 | 49817-0084-1, 49817-0084-6, 49817-0084-7 |
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 |
|---|---|---|---|---|---|---|
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER / RESPIRATORY (INHALATION) | 0.04 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 0.02 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 70 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SOLUTION / ORAL | 360 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SOAP / TOPICAL | 6 %w/w | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | CAPSULE / ORAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | CAPSULE, DELAYED RELEASE / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION, SUSPENSION / INTRALESIONAL | 20 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRA-ARTICULAR | 1 %w/v | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | INJECTION, EMULSION / INTRAVENOUS | 0.02 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / INTRACAVITARY | 0.01 ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1800 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / BUCCAL | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUSPENSION / ORAL | 100 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | INJECTION / ENDOTRACHEAL | 54 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| TOCOPHEROL | TOCOPHEROL | R0ZB2556P8 | TABLET / ORAL | 0.08 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET / SUBLINGUAL | 0.13 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SUPPOSITORY / RECTAL | 1 mg | ||
| BENZYL ALCOHOL | BENZYL ALCOHOL | LKG8494WBH | SUPPOSITORY / VAGINAL | 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 |
|---|---|---|---|---|---|---|
| ed172d43-79f7-117a-e053-2995a90ab91c | 1170af9b-cbf3-43d3-a8b0-bea1f2a83377 | 2022-11-09 | Warnings | 1170af9b-cbf3-43d3-a8b0-bea1f2a83377 |
Adverse event summaries are temporarily unavailable. Other product information remains available.