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 liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 su...
protect this product in this container from excessive heat and direct sun.
Drug Facts
| Active ingredients | Purpose |
|---|---|
| AVOBENZONE 2.5% | Sunscreen |
| OCTINOXATE 7.4% | Sunscreen |
| OCTOCRYLENE 2.0% | 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∙BUTYLENE GLYCOL∙GLYCERIN∙CAPRYLIC/CAPRIC TRIGLYCERIDE∙ISOHEXADECANE∙BEHENYL ALCOHOL∙TRIISOSTEARIN∙MYRISTYL MYRISTATE∙DIMETHICONE∙PEG/PPG-14/7 DIMETHYL ETHER∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙SILICA∙TREHALOSE∙POTASSIUM METHOXYSALICYLATE∙PHYTOSTERYL MACADAMIATE∙TOCOPHERYL ACETATE∙CAMELLIA JAPONICA SEED OIL∙POLYQUATERNIUM-51∙ROSA DAMASCENA FLOWER WATER∙SODIUM ACETYLATED HYALURONATE∙DIPOTASSIUM GLYCYRRHIZATE∙PRUNUS SPECIOSA LEAF EXTRACT∙PAEONIA SUFFRUTICOSA ROOT EXTRACT∙OLEA EUROPAEA (OLIVE) LEAF EXTRACT∙AESCULUS HIPPOCASTANUM (HORSE CHESTNUT) SEED EXTRACT∙2-O-ETHYL ASCORBIC ACID∙ROSE EXTRACT∙BUPLEURUM FALCATUM ROOT EXTRACT∙HYDROLYZED CONCHIOLIN PROTEIN∙HYDROLYZED SILK∙STEARYL ALCOHOL∙BEHENETH-20∙SUCCINOGLYCAN∙TRISODIUM EDTA∙SODIUM CITRATE∙ALCOHOL∙SODIUM METAPHOSPHATE∙CITRIC ACID∙BHT∙SODIUM METABISULFITE∙ALUMINA∙TOCOPHEROL∙PHENOXYETHANOL∙FRAGRANCE∙TITANIUM DIOXIDE∙IRON OXIDES∙
Call toll free 1-800-906-7503
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58411-236-60 | 2023-12-20 | C162847 | 48780-1 | 9d75b9d1-1c2c-f424-e053-dadaa90a57ce | CLÉ DE PEAU BEAUTÉ HAND CREAM |
| 58411-236-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-1c2c-f424-e053-dadaa90a57ce | CLÉ DE PEAU BEAUTÉ HAND CREAM |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| 2-O-ETHYL ASCORBIC ACID | INACTIVE INGREDIENT | 801M14RK9K | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| BEHENETH-20 | INACTIVE INGREDIENT | BJ4GP2IFLN | 1 | |
| BUPLEURUM FALCATUM ROOT | INACTIVE INGREDIENT | X04E310LUY | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CAMELLIA JAPONICA SEED OIL | INACTIVE INGREDIENT | U37N0S910T | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GLYCYRRHIZINATE DIPOTASSIUM | INACTIVE INGREDIENT | CA2Y0FE3FX | 1 | |
| HORSE CHESTNUT | INACTIVE INGREDIENT | 3C18L6RJAZ | 1 | |
| ISOHEXADECANE | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| MYRISTYL MYRISTATE | INACTIVE INGREDIENT | 4042ZC00DY | 1 | |
| OLEA EUROPAEA LEAF | INACTIVE INGREDIENT | MJ95C3OH47 | 1 | |
| PAEONIA SUFFRUTICOSA ROOT | INACTIVE INGREDIENT | 7M7E9A2C8J | 1 | |
| PEG/PPG-14/7 DIMETHYL ETHER | INACTIVE INGREDIENT | 6DNW9T7YT2 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POTASSIUM METHOXYSALICYLATE | INACTIVE INGREDIENT | 5G3H7U4Y7F | 1 | |
| PRUNUS SPECIOSA LEAF | INACTIVE INGREDIENT | Q71D900FVU | 1 | |
| ROSA DAMASCENA FLOWER OIL | INACTIVE INGREDIENT | 18920M3T13 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM ACETYLATED HYALURONATE | INACTIVE INGREDIENT | WN66R7GL93 | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | 1 | |
| SODIUM POLYMETAPHOSPHATE | INACTIVE INGREDIENT | P1BM4ZH95L | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| TRIISOSTEARIN | INACTIVE INGREDIENT | 71503RH8KG | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58411-236 | 58411-236-60 |
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 |
|---|---|---|---|---|---|---|
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | INJECTION, EMULSION / INTRAVENOUS | 1.1 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER, FOR SUSPENSION / ORAL | 3390 mg/5ml | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, FILM COATED / ORAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SUSPENSION / ORAL | 200 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | SYRUP / ORAL | 80 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CAPSULE / ORAL | 238 mg | ||
| BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TOPICAL | 1400 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SPRAY / NASAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GEL, METERED / TOPICAL | 4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED / ORAL | 3 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CREAM / VAGINAL | 425 mg | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | TABLET, CHEWABLE / ORAL | 0.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER / ORAL | 840 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | OINTMENT / TOPICAL | 57 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TRANSDERMAL | 500 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SHAMPOO / TOPICAL | 17 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| .ALPHA.-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SYSTEM / TOPICAL | 0.1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION, CONCENTRATE / INTRAVENOUS | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INTRABURSAL | ADJ PH | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EXTENDED RELEASE / ORAL | 45 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | CONCENTRATE / ORAL | 5.3 mg/1ml | ||
| SODIUM METABISULFITE | SODIUM METABISULFITE | 4VON5FNS3C | INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS | 0.15 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / VAGINAL | 8 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | AEROSOL, FOAM / TOPICAL | 37 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | POWDER / SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|
| 2317b4fb-5585-417c-afb0-28f7eaa4bc3c | 91d1f153-152d-4ea9-8682-bfac85d47611 | 2023-10-20 | Warnings | 91d1f153-152d-4ea9-8682-bfac85d47611 |
Adverse event summaries are temporarily unavailable. Other product information remains available.