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 5.00%
TITANIUM DIOXIDE 3.90%
Sunscreen
Sunscreen
WATER/AQUA/EAU, CYCLO- PENTASILOXANE, ETHYLHEXYL ISONONANOATE, POLYMETHYL- SILSESQUIOXANE, DIMETHICONE, BUTYLENE GLYCOL, GLYCERIN, NYLON-12, ISODODECANE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALCOHOL DENAT., MICA, C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER, BORON NITRIDE, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ALUMINUM DIMYRISTATE, BAMBUSA ARUNDINACEA STEM POWDER, CITRIC ACID, CYCLOHEXA- SILOXANE, DIMETHICONE/ PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIPROPYLENE GLYCOL DISODIUM EDTA, DISODIUM STEAROYL GLUTAMATE, HYDROXYETHYL- CELLULOSE, LAUROYL LYSINE, LECITHIN, MAGNESIUM SULFATE, PENTYLENE GLYCOL, POLYSORBATE 60, SACCHARIDE ISOMERATE, SILICA, SODIUM CITRATE, SORBITAN STEARATE, TOCOPHEROL, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYL- SILANE, ZINC GLYCYRRHETINATE, BHT, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE [MAY CONTAIN/PEUT CONTENIR (+/-) IRON OXIDES (Cl 77491, Cl 77492, Cl 77499), TITANIUM DIOXIDE (Cl 77891).
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67938-2061-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-dd5c-f424-e053-dadaa90a57ce | f6687440-3fa0-4ce5-aaad-011385bc9f35 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67938-2061-1 | FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT SHELL | 1 in 1 BOX | CREAM | 1 | 1 | |
| 67938-2061-2 | FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT SHELL | 30 mL in 1 BOTTLE | CREAM | 30 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 67938-2061 | FLAWLESS FINISH PERFECTLY SATINB 24HR MAKEUP SHADE SOFT SHELL (OCTINOXATE, TITANIUM DIOXIDE) CREAM [ELIZABETH ARDEN, INC] | 1 | Legacy NDC, 2 package rows | 20150130_f6687440-3fa0-4ce5-aaad-011385bc9f35.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALUMINUM DIMYRISTATE | INACTIVE INGREDIENT | J2KA067N9O | 1 | |
| BAMBUSA BAMBOS STEM | INACTIVE INGREDIENT | NRA4497HC5 | 1 | |
| BORON NITRIDE | INACTIVE INGREDIENT | 2U4T60A6YD | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| DISODIUM STEAROYL GLUTAMATE | INACTIVE INGREDIENT | 45ASM2L11M | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| ETHYLHEXYL ISONONANOATE | INACTIVE INGREDIENT | I6KB4GE3K4 | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| ISODODECANE | INACTIVE INGREDIENT | A8289P68Y2 | 1 | |
| LAUROYL LYSINE | INACTIVE INGREDIENT | 113171Q70B | 1 | |
| LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE | INACTIVE INGREDIENT | 25G622K2RA | 1 | |
| MAGNESIUM SULFATE | INACTIVE INGREDIENT | DE08037SAB | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| NYLON-12 | INACTIVE INGREDIENT | 446U8J075B | 1 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 1 | |
| SACCHARIDE ISOMERATE | INACTIVE INGREDIENT | W8K377W98I | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SORBITAN MONOSTEARATE | INACTIVE INGREDIENT | NVZ4I0H58X | 1 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67938-2061 | 67938-2061-2, 67938-2061-1 |
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | SUSPENSION / TOPICAL | 2.15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYRUP / ORAL | 16734 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | TABLET, COATED / ORAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM / SUBLINGUAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / TOPICAL | 0.01 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | FILM, SOLUBLE / ORAL | 0.06 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CREAM / TOPICAL | 4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | LOTION / TOPICAL | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | FILM / BUCCAL | 0.27 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRACARDIAC | 1.05 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| SORBITAN MONOSTEARATE | SORBITAN MONOSTEARATE | NVZ4I0H58X | OINTMENT / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVASCULAR | 0.48 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, DELAYED RELEASE / ORAL | 7 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SYRUP / ORAL | 40 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET, FILM COATED / ORAL | 0.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, FILM COATED / ORAL | 42 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / DENTAL | 15 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / BUCCAL | NA | ||
| MAGNESIUM SULFATE | MAGNESIUM SULFATE | DE08037SAB | TABLET, COATED / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / SUBCUTANEOUS | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | MOUTHWASH / BUCCAL | 100 mg/1ml |
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 |
|---|---|---|---|---|---|---|
| 090c039e-0021-4915-8e1f-a0f52b5995b1 | f6687440-3fa0-4ce5-aaad-011385bc9f35 | 2015-01-05 | Warnings | 090c039e-0021-4915-8e1f-a0f52b5995b1 f6687440-3fa0-4ce5-aaad-011385bc9f35 |
Adverse event summaries are temporarily unavailable. Other product information remains available.