Label: CLE DE PEAU BEAUTE UV PROTECTIVE- octinoxate, octocrylene, and zinc oxide cream
- NDC Code(s): 58411-291-60
- Packager: SHISEIDO AMERICAS CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
- Warnings
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Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
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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 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
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Inactive Ingredients
WATER•DIPROPYLENE GLYCOL•ISOHEXADECANE•ISOPROPYL MYRISTATE•GLYCERIN•SD ALCOHOL 40-B•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•DIMETHICONE•POLYMETHYL METHACRYLATE•DISTEARDIMONIUM HECTORITE•POLYMETHYLSILSESQUIOXANE•PEG/PPG-14/7 DIMETHYL ETHER•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•MACADAMIA SEED OIL POLYGLYCERYL-6 ESTERS BEHENATE•PEG-6•PEG-32•SILICA•TREHALOSE•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPILLUM EXTRACT•CRATAEGUS MONOGYNA FLOWER EXTRACT•HYDROLYZED SILK•2-O-ETHYL ASCORBIC ACID•SCUTELLARIA BAICALENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•BUPLEURUM FALCATUM ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•HYDROGENATED POLYDECENE•HYDROGEN DIMETHICONE•ISOSTEARIC ACID•BUTYLENE GLYCOL•TRISODIUM EDTA•TALC•ALCOHOL•BHT•TOCOPHEROL•TRIETHOXYCAPRYLYLSILANE•THEANINE•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•TITANIUM DIOXIDE•MICA•
- Other information
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
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INGREDIENTS AND APPEARANCE
CLE DE PEAU BEAUTE UV PROTECTIVE
octinoxate, octocrylene, and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-291 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3870 mg in 50 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 1569 mg in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8577 mg in 50 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) DIMETHICONE (UNII: 92RU3N3Y1O) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TREHALOSE (UNII: B8WCK70T7I) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) GINKGO (UNII: 19FUJ2C58T) THYMUS SERPYLLUM (UNII: 86H4S6K51N) CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J) 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I) HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M) ASIAN GINSENG (UNII: CUQ3A77YXI) BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY) HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7) HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI) ISOSTEARIC ACID (UNII: X33R8U0062) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE TRISODIUM (UNII: 420IP921MB) TALC (UNII: 7SEV7J4R1U) ALCOHOL (UNII: 3K9958V90M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) THEANINE (UNII: 8021PR16QO) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MICA (UNII: V8A1AW0880) WATER (UNII: 059QF0KO0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) ISOHEXADECANE (UNII: 918X1OUF1E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58411-291-60 1 in 1 CARTON 02/01/2017 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2017 Labeler - SHISEIDO AMERICAS CORPORATION (193691821) Establishment Name Address ID/FEI Business Operations SHISEIDO AMERICA INC. 782677132 manufacture(58411-291) , analysis(58411-291)
