Indications and uses
helps prevent sunburn higher SPF gives more sunburn protection
helps prevent sunburn higher SPF gives more sunburn protection
apply evenly before sun exposure and as needed. children under 6 months of age: ask a doctor.
Drug Facts
| Active ingredients | Purpose |
|---|---|
| OCTINOXATE 7.4% | Sunscreen |
| OCTOCRYLENE 3.0% | Sunscreen |
| OXYBENZONE 1.5% | Sunscreen |
| ZINC OXIDE 9.0% | Sunscreen |
For external use only
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
WATER • BUTYLENE GLYCOL • ISOHEXADECANE • DIMETHICONE • ISOPROPYL MYRISTATE • GLYCERIN • POLYMETHYLSILSESQUIOXANE • SD ALCOHOL 40-B • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • PEG-6 • XYLITOL • PEG-32 • SODIUM HYALURONATE • TOCOPHERYL ACETATE • LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE • CRATAEGUS MONOGYNA FLOWER EXTRACT • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • 2-O-ETHYL ASCORBIC ACID • SODIUM ACETYLATED HYALURONATE • POLYQUATERNIUM-51 • SAXIFRAGA SARMENTOSA EXTRACT • UNCARIA GAMBIR EXTRACT • GINKGO BILOBA LEAF EXTRACT • THYMUS SERPILLUM EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • CURCUMA LONGA (TURMERIC) ROOT EXTRACT • HYPERICUM ERECTUM EXTRACT • HYDROLYZED SILK • BUPLEURUM FALCATUM ROOT EXTRACT • HYDROGENATED POLYDECENE • SILICA • ISOSTEARIC ACID • HYDROGEN DIMETHICONE • TRISODIUM EDTA • BHT • ALCOHOL • TOCOPHEROL • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE • MICA •
1-800-906-7503
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52686-259-60 | 2023-10-06 | C162847 | 48780-1 | 9d75b9d1-1b60-f424-e053-dadaa90a57ce | CLE DE PEAU BEAUTE UV PROTECTION CREAM |
| 52686-259-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1b60-f424-e053-dadaa90a57ce | CLE DE PEAU BEAUTE UV PROTECTION CREAM |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Zinc oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| Zinc oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| 2-O-ETHYL ASCORBIC ACID | INACTIVE INGREDIENT | 801M14RK9K | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| BUPLEURUM FALCATUM ROOT | INACTIVE INGREDIENT | X04E310LUY | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CRATAEGUS MONOGYNA FLOWER | INACTIVE INGREDIENT | NT52AMP29J | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| GINKGO | INACTIVE INGREDIENT | 19FUJ2C58T | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCYRRHIZINATE DIPOTASSIUM | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| HYDROGENATED POLYDECENE (550 MW) | INACTIVE INGREDIENT | U333RI6EB7 | 1 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 1 | |
| ISOSTEARIC ACID | INACTIVE INGREDIENT | X33R8U0062 | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYETHYLENE GLYCOL 1500 | INACTIVE INGREDIENT | 1212Z7S33A | 1 | |
| POLYETHYLENE GLYCOL 300 | INACTIVE INGREDIENT | 5655G9Y8AQ | 1 | |
| POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) | INACTIVE INGREDIENT | 59Z907ZB69 | 1 | |
| ROSA ROXBURGHII FRUIT | INACTIVE INGREDIENT | CVT1AA87FF | 1 | |
| SAXIFRAGA STOLONIFERA LEAF | INACTIVE INGREDIENT | O3TMV4903H | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| THIOTAURINE | INACTIVE INGREDIENT | NQZ2D7AO62 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TURMERIC | INACTIVE INGREDIENT | 856YO1Z64F | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 52686-259 | 52686-259-60 |
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 | SPRAY / TOPICAL | 3633 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL, FOAM / TOPICAL | 144 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | AEROSOL / TOPICAL | 9.3 %w/w | ||
| XYLITOL | XYLITOL | VCQ006KQ1E | PASTE / ORAL | 180 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRA-ARTICULAR | 23 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, COATED / ORAL | 176 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL / TOPICAL | 29 mg | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| POLYETHYLENE GLYCOL 1500 | POLYETHYLENE GLYCOL 1600 | 1212Z7S33A | PASTE / DENTAL | 4.96 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| POLYETHYLENE GLYCOL 300 | POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | TABLET, FILM COATED / ORAL | 2 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, EXTENDED RELEASE / ORAL | 0.03 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED / ORAL | 3 mg | ||
| POLYETHYLENE GLYCOL 1500 | POLYETHYLENE GLYCOL 1600 | 1212Z7S33A | TABLET, COATED / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUPPOSITORY / RECTAL | 14 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 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 |
|---|---|---|---|---|---|---|
| 374a4f0a-8208-4bf0-acdc-44fbc7339c8f | ab689c4a-e276-4c6f-9d0d-97ce06e9332d | 2023-10-06 | Warnings | ab689c4a-e276-4c6f-9d0d-97ce06e9332d |
Adverse event summaries are temporarily unavailable. Other product information remains available.