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 time in...
protect the product in this container from excessive heat and direct sun.
Drug Facts
Octinoxate 7.5%
Octisalate 4%
Oxybenzone 2.5%
Titanium dioxide 1.1%
Sunscreen
Helps prevent sunburn
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, dimethicone, butylene glycol, phenyl trimethicone, pentylene glycol, glyceryl stearate, behenyl alcohol, trioctyldodecyl citrate, polymethylsilsesquioxane, octyldodecyl stearoyl stearate, peg-40 stearate, polyglyceryl-10 pentastearate, ammonium acryloyldimethyltaurate/vp copolymer, triticum vulgare (wheat) germ extract, hordeum vulgare (barley) extract/extrait d'orge, cucumis sativus (cucumber) fruit extract, laminaria saccharina extract, pyrus malus (apple) fruit extract, scutellaria baicalensis root extract, polyquaternium-51, acetyl hexapeptide-8, trehalose, oryzanol, octyldodecyl neopentanoate, urea, polyglyceryl-6 polyricinoleate, propylene glycol laurate, glycyrrhetinic acid, tocopheryl acetate, sucrose, glycerin, sodium stearoyl lactylate, caffeine, linoleic acid, cholesterol, lecithin, squalane, sodium pca, isopropyl titanium triisostearate, propylene glycol stearate, stearic acid, polysorbate 20, sorbitan laurate, xanthan gum, sodium hyaluronate, silica, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, alumina, disodium edta, sodium dehydroacetate, chlorphenesin, phenoxyethanol, [+/- titanium dioxide (ci 77891), zinc oxide (ci 77947), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499), mica] <iln41057>
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 | |
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| .alpha.-tocopherol acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| acetyl hexapeptide-8 | INACTIVE INGREDIENT | L4EL31FWIL | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| ammonium acryloyldimethyltaurate/vp copolymer | INACTIVE INGREDIENT | W59H9296ZG | 1 | |
| apple | INACTIVE INGREDIENT | B423VGH5S9 | 1 | |
| butylene glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| caffeine | INACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| cholesterol | INACTIVE INGREDIENT | 97C5T2UQ7J | 1 | |
| cucumber | INACTIVE INGREDIENT | YY7C30VXJT | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| docosanol | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| enoxolone | INACTIVE INGREDIENT | P540XA09DR | 1 | |
| ferric oxide red | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| ferric oxide yellow | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | 1 | |
| gamma oryzanol | INACTIVE INGREDIENT | SST9XCL51M | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| hyaluronate sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| isopropyl titanium triisostearate | INACTIVE INGREDIENT | 949E3KBJ1I | 1 | |
| linoleic acid | INACTIVE INGREDIENT | 9KJL21T0QJ | 1 | |
| mica | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| octyldodecyl neopentanoate | INACTIVE INGREDIENT | X8725R883T | 1 | |
| octyldodecyl stearoyl stearate | INACTIVE INGREDIENT | 3D47Q6D93C | 1 | |
| peg-40 stearate | INACTIVE INGREDIENT | ECU18C66Q7 | 1 | |
| pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) | INACTIVE INGREDIENT | 255PIF62MS | 1 | |
| pentylene glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| phenyl trimethicone | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| propylene glycol monolaurate | INACTIVE INGREDIENT | 668Z5835Z3 | 1 | |
| propylene glycol stearate | INACTIVE INGREDIENT | MZM1I680W0 | 1 | |
| saccharina latissima | INACTIVE INGREDIENT | 68CMP2MB55 | 1 | |
| scutellaria baicalensis root | INACTIVE INGREDIENT | 7J95K7ID2S | 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 | |
| sorbitan monolaurate | INACTIVE INGREDIENT | 6W9PS8B71J | 1 | |
| squalane | INACTIVE INGREDIENT | GW89575KF9 | 1 | |
| stearic acid | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 | |
| sucrose | INACTIVE INGREDIENT | C151H8M554 | 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 | |
| zinc oxide | INACTIVE INGREDIENT | SOI2LOH54Z | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 16555-007 | 16555-007-01 |
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 |
|---|---|---|---|---|---|---|
| urea | UREA | 8W8T17847W | CREAM / VAGINAL | 0.64 %w/w | ||
| sorbitan monolaurate | SORBITAN MONOLAURATE | 6W9PS8B71J | SPRAY, METERED / NASAL | 1 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | TABLET / ORAL | 56 mg | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | CREAM / VAGINAL | 0.3 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / TOPICAL | 0.11 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| .alpha.-tocopherol acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| caffeine | CAFFEINE | 3G6A5W338E | SOLUTION / OPHTHALMIC | 2 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| ferrosoferric oxide | FERROSOFERRIC OXIDE | XM0M87F357 | CAPSULE, COATED / ORAL | 0.11 mg | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | LOTION / TOPICAL | 2000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET / ORAL | 24 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| propylene glycol monolaurate | PROPYLENE GLYCOL MONOLAURATE | 668Z5835Z3 | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| cholesterol | CHOLESTEROL | 97C5T2UQ7J | INJECTION / INTRAVENOUS | 93 mg | ||
| polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| ferric oxide yellow | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, COATED / ORAL | 0.01 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| squalane | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SUBCUTANEOUS | 6 mg | ||
| butylene glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| propylene glycol stearate | PROPYLENE GLYCOL MONOSTEARATE | MZM1I680W0 | CREAM / TOPICAL | 257 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| stearic acid | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| urea | UREA | 8W8T17847W | DOUCHE / VAGINAL | 8 %w/w | ||
| ferric oxide red | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| docosanol | DOCOSANOL | 9G1OE216XY | SOLUTION / TOPICAL | 1.1 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / TOPICAL | 6 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v |
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 |
|---|---|---|---|---|---|---|
| 4138f0fc-913c-4ea7-b909-363fb6043d16 | d022a02c-a3cd-40c0-a2a5-3c20712f7abf | 2020-11-16 | Warnings | d022a02c-a3cd-40c0-a2a5-3c20712f7abf |
Adverse event summaries are temporarily unavailable. Other product information remains available.