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
For sunscreen use: apply generously and evenly 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: l...
protect the product in this container from excessive heat and direct sun
Drug Facts
| Active ingredients | Purpose |
|---|---|
| octinoxate 7.50% | Sunscreen |
| octisalate 4.00% | Sunscreen |
| oxybenzone 3.50% | Sunscreen |
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
For sunscreen use:
water\aqua\eau • trioctyldodecyl citrate • silica • phenyl trimethicone • butylene glycol • glyceryl stearate • behenyl alcohol • dimethicone • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • pentylene glycol • citrus aurantium bergamia (bergamot) fruit oil1, citrus limon (lemon) peel oil1, citrus aurantium dulcis (orange) peel oil1, cinnamomum camphora (camphor) bark oil1, mentha viridis (spearmint) leaf oil1, magnolia acuminata flower extract, iris pallida root extract, rosa damascena extract, citral, linalool, limonene • algae extract • camellia sinensis (white tea) leaf extract • camellia sinensis (green tea) leaf extract • sapindus mukurossi fruit extract • glycyrrhiza glabra (licorice) root extract • laminaria saccharina extract • thermus thermophillus ferment • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • castanea sativa (chestnut) seed extract • salicylic acid • cholesterol • sucrose • caffeine • arginine • macadamia ternifolia seed oil • hydrogenated polyisobutene • hydrogenated lecithin • tocopheryl acetate • ethylhexylglycerin • glycerin • caesalpinia spinosa gum • isopropyl myristate • lecithin • polyquaternium-51 • sodium stearoyl lactylate • ammonium acryloyldimethyltaurate/vp copolymer • squalane • sodium pca • urea • glycyrrhetinic acid • polymethyl methacrylate • sodium hyaluronate • galactoarabinan • sodium dehydroacetate • citric acid • phospholipids • trehalose • xanthan gum • ascorbyl tocopheryl maleate • disodium edta • bht • phenoxyethanol • [+/- titanium dioxide (ci 77891) • iron oxides (ci 77491, ci 77492, ci 77499) • mica] <iln40554>
1 essential oil
protect the product in this container from excessive heat and direct sun
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .alpha.-tocopherol acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| ammonium acryloyldimethyltaurate/vp copolymer | INACTIVE INGREDIENT | W59H9296ZG | 1 | |
| arginine | INACTIVE INGREDIENT | 94ZLA3W45F | 1 | |
| ascorbyl tocopheryl maleate | INACTIVE INGREDIENT | D2G6259XR5 | 1 | |
| bergamot oil | INACTIVE INGREDIENT | 39W1PKE3JI | 1 | |
| butylated hydroxytoluene | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| butylene glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| caesalpinia spinosa resin | INACTIVE INGREDIENT | WL3883U2PO | 1 | |
| caffeine | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| camphor oil | INACTIVE INGREDIENT | 75IZZ8Y727 | 1 | |
| cholesterol | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| citral | INACTIVE INGREDIENT | T7EU0O9VPP | 1 | |
| citric acid monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| docosanol | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| enoxolone | INACTIVE INGREDIENT | P540XA09DR | 1 | |
| ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| galactoarabinan | INACTIVE INGREDIENT | SL4SX1O487 | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| glycyrrhiza glabra | INACTIVE INGREDIENT | 2788Z9758H | 1 | |
| green tea leaf | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| hyaluronate sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| hydrogenated soybean lecithin | INACTIVE INGREDIENT | H1109Z9J4N | 1 | |
| iris pallida root | INACTIVE INGREDIENT | LVV57EM5OG | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| lemon oil | INACTIVE INGREDIENT | I9GRO824LL | 1 | |
| linalool, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 1 | |
| macadamia oil | INACTIVE INGREDIENT | 515610SU8C | 1 | |
| magnolia acuminata flower | INACTIVE INGREDIENT | 8LCB7ZW9UL | 1 | |
| mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| octyldodecyl stearoyl stearate | INACTIVE INGREDIENT | 3D47Q6D93C | 1 | |
| orange oil | INACTIVE INGREDIENT | AKN3KSD11B | 1 | |
| peg-40 stearate | INACTIVE INGREDIENT | ECU18C66Q7 | 1 | |
| pentylene glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| phenyl trimethicone | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| saccharina latissima | INACTIVE INGREDIENT | 68CMP2MB55 | 1 | |
| salicylic acid | INACTIVE INGREDIENT | O414PZ4LPZ | 1 | |
| sapindus mukorossi fruit | INACTIVE INGREDIENT | 66H9NW427Y | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| sodium dehydroacetate | INACTIVE INGREDIENT | 8W46YN971G | 1 | |
| sodium pyrrolidone carboxylate | INACTIVE INGREDIENT | 469OTG57A2 | 1 | |
| sodium stearoyl lactylate | INACTIVE INGREDIENT | IN99IT31LN | 1 | |
| spanish chestnut | INACTIVE INGREDIENT | 2MT5XMR2YW | 1 | |
| spearmint oil | INACTIVE INGREDIENT | C3M81465G5 | 1 | |
| squalane | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 | |
| thermus thermophilus lysate | INACTIVE INGREDIENT | 775R692494 | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| trehalose | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| trioctyldodecyl citrate | INACTIVE INGREDIENT | 35X8CT063R | 1 | |
| urea | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| wheat germ | INACTIVE INGREDIENT | YR3G369F5A | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 59427-111 | 59427-111-01 |
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 |
|---|---|---|---|---|---|---|
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, EXTENDED RELEASE / ORAL | 529 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTABLE, LIPOSOMAL / INFILTRATION | 0.47 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SYRUP / ORAL | 722 mg/5ml | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| .alpha.-tocopherol acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | CAPSULE / ORAL | 2 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| caffeine | CAFFEINE | 3G6A5W338E | SOLUTION / OPHTHALMIC | 2 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / IONTOPHORESIS | 0.1 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | EMULSION / TOPICAL | 0.11 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | GEL / OPHTHALMIC | 0.88 %w/w | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 1 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, DELAYED RELEASE / ORAL | 14 mg | ||
| titanium dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / TOPICAL | 17 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | ENEMA / RECTAL | 60 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| butylated hydroxytoluene | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL / TOPICAL | 8 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRATHECAL | ADJ PH | ||
| arginine | ARGININE | 94ZLA3W45F | INJECTION / INTRAMUSCULAR | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| arginine | ARGININE | 94ZLA3W45F | TABLET / ORAL | 50 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE, EXTENDED RELEASE / ORAL | 101 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | OIL / TOPICAL | 213 mg | ||
| sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| lemon oil | LEMON OIL, COLD PRESSED | I9GRO824LL | SUSPENSION / ORAL | 1 mg | ||
| butylene glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| isopropyl myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| citric acid monohydrate | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRA-ARTICULAR | ADJ PH |
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 |
|---|---|---|---|---|---|---|
| 2dab8941-f4fa-48b0-98bf-3c39a23ce836 | a9dfa6b8-4b1a-4233-91f0-ad7423b2e04f | 2020-11-17 | Warnings | a9dfa6b8-4b1a-4233-91f0-ad7423b2e04f |
Adverse event summaries are temporarily unavailable. Other product information remains available.