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 Reapply: at least every 2 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from ...
Drug Facts
OCTINOXATE 4.0%
TITANIUM DIOXIDE 3.0%
Sunscreen
Sunscreen
WATER/AQUA/EAU, CYCLOPENTASILOXANE, DIMETHICONE, ISOHEXADECANE, MICA, GLYCERIN, SORBITAN ISOSTEARATE, DIMETHICONE CROSSPOLYMER, ALUMINA, CAPRYLYL DIMETHICONE ETHOXY GLUCOSIDE, ALUMINUM/MAGNESIUM HYDROXIDE STEARATE, ACETYL OCTAPEPTIDE-3, ALANINE, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, ASPARTIC ACID, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CHOLESTEROL DEXTRIN, DISODIUM EDTA, FRUCTOSE, GLUCOSE, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, LECITHIN, MANNITOL, PCA DIMETHICONE PHYTOSPHINGOSINE, POLYPERFLUOROETHOXYMET HOXY DIFLUOROETHYL PEG PHOSPHATE, POLYQUATERNIUM-51, RETINYL PALMITATE, SILICA SILYLATE, SODIUM CHLORIDE, SODIUM HYALURONATE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SORBITOL, SUCROSE, TOCOPHEROL, TREHALOSE, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT UREA, XANTHAN GUM, ZINC STEARATE, BHT, BENZOIC ACID CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, POTASSIUM SORBATE, PROPYLPARABEN, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67938-0946-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f611-f424-e053-dadaa90a57ce | c77e958f-5743-47a3-accc-72f8b04af9ff |
| 67938-0946-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f611-f424-e053-dadaa90a57ce | c77e958f-5743-47a3-accc-72f8b04af9ff |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67938-0946-1 | CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COGNAC | 1 in 1 BOX | CREAM | 1 | 3 | |
| 67938-0946-2 | CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COGNAC | 32 g in 1 JAR | CREAM | 32 | 3 | |
| 67938-0946-3 | CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COGNAC | 25000 g in 1 PAIL | CREAM | 25000 | 3 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67938-0946 | CERAMIDE LIFT AND FIRM MAKEUP BROAD SPECTRUM SUNSCREEN SPF 15 COGNAC (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ELIZABETH ARDEN, INC] | 3 | Legacy NDC, 3 package rows | 20150824_c77e958f-5743-47a3-accc-72f8b04af9ff.zip |
| 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 | |
| ABELMOSCHUS MOSCHATUS SEED | INACTIVE INGREDIENT | UN2QZ55I88 | 3 | |
| ACETYL OCTAPEPTIDE-3 | INACTIVE INGREDIENT | 8K14HJF88S | 3 | |
| ALANINE | INACTIVE INGREDIENT | OF5P57N2ZX | 3 | |
| ALPINIA ZERUMBET LEAF | INACTIVE INGREDIENT | MS8P33AMKX | 3 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 3 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 3 | |
| ASPARTIC ACID | INACTIVE INGREDIENT | 30KYC7MIAI | 3 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 3 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 3 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 3 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 3 | |
| CERAMIDE 1 | INACTIVE INGREDIENT | 5THT33P7X7 | 3 | |
| CERAMIDE 3 | INACTIVE INGREDIENT | 4370DF050B | 3 | |
| CERAMIDE 6 II | INACTIVE INGREDIENT | F1X8L2B00J | 3 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 3 | |
| CHOLESTEROL | INACTIVE INGREDIENT | 97C5T2UQ7J | 3 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 3 | |
| DEXTROSE, UNSPECIFIED FORM | INACTIVE INGREDIENT | IY9XDZ35W2 | 3 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 3 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 3 | |
| FRUCTOSE | INACTIVE INGREDIENT | 6YSS42VSEV | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 3 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 3 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 3 | |
| ICODEXTRIN | INACTIVE INGREDIENT | 2NX48Z0A9G | 3 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 3 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 3 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 3 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 3 | |
| PHYTOSPHINGOSINE | INACTIVE INGREDIENT | GIN46U9Q2Q | 3 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 3 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 3 | |
| SODIUM LAUROYL LACTYLATE | INACTIVE INGREDIENT | 7243K85WFO | 3 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | 3 | |
| SORBITAN ISOSTEARATE | INACTIVE INGREDIENT | 01S2G2C1E4 | 3 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 3 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 3 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 3 | |
| TRIFOLIUM PRATENSE FLOWER | INACTIVE INGREDIENT | 4JS0838828 | 3 | |
| UREA | INACTIVE INGREDIENT | 8W8T17847W | 3 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 3 | |
| ZINC STEARATE | INACTIVE INGREDIENT | H92E6QA4FV | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67938-0946 | 67938-0946-2, 67938-0946-1, 67938-0946-3 |
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 |
|---|---|---|---|---|---|---|
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 15400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION / OPHTHALMIC | 0.6 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| FRUCTOSE | FRUCTOSE | 6YSS42VSEV | TABLET / ORAL | 64.92 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | CONCENTRATE / INTRAVENOUS | 220 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SUSPENSION/ DROPS / OPHTHALMIC | 3.3 %w/v | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SOLUTION, CONCENTRATE / ORAL | 0.1 mg/1ml | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | OINTMENT / TOPICAL | 12 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| UREA | UREA | 8W8T17847W | SYSTEM / TOPICAL | 840 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, EXTENDED RELEASE / ORAL | 15 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / AURICULAR (OTIC) | 0.1 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SOLUTION / INTRAVENOUS | 5 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 4.35 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRA-ARTICULAR | 26 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| CHOLESTEROL | CHOLESTEROL | 97C5T2UQ7J | INJECTION / INTRAVENOUS | 93 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| UREA | UREA | 8W8T17847W | CREAM / VAGINAL | 0.64 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SPRAY, METERED / NASAL | 36 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBARACHNOID | 0.9 %w/v | ||
| FRUCTOSE | FRUCTOSE | 6YSS42VSEV | SOLUTION / RECTAL | 0.67 %w/v | ||
| MANNITOL | MANNITOL | 3OWL53L36A | SOLUTION / ORAL | 869 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | TABLET, DELAYED RELEASE / ORAL | 97 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR | 0.86 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, COATED / ORAL | 0.8 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | PASTE, DENTIFRICE / DENTAL | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / IONTOPHORESIS | 0.6 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | POWDER, FOR SUSPENSION / ORAL | 12000 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| MANNITOL | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / PARENTERAL | 200 mg | ||
| DEXTROSE, UNSPECIFIED FORM | DEXTROSE | IY9XDZ35W2 | SYRUP / ORAL | 620 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAMUSCULAR | 23 mg | ||
| ZINC STEARATE | ZINC STEARATE | H92E6QA4FV | TABLET / BUCCAL | 2.5 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET / ORAL | 0.2 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 |
|---|---|---|---|---|---|---|
| 7429d99c-fc8f-4262-a137-0befc7475367 | c77e958f-5743-47a3-accc-72f8b04af9ff | 2015-07-16 | Warnings | 7429d99c-fc8f-4262-a137-0befc7475367 c77e958f-5743-47a3-accc-72f8b04af9ff |
Adverse event summaries are temporarily unavailable. Other product information remains available.