CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY- octinoxate, octocrylene, titanium dioxide, and zinc oxide emulsion 
SHISEIDO AMERICAS CORPORATION

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.

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CLÉ DE PEAU BEAUTÉ UV PROTECTIVE VERY HIGH PROTECTION FOR BODY

Drug Facts

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
TITANIUM DIOXIDE 1.5%Sunscreen
ZINC OXIDE 19.3%Sunscreen

Uses

Warnings

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.

Flammable

Do not use near heat, flame, or while smoking

Directions

Inactive Ingredients

DIMETHICONE•WATER•BUTYLENE GLYCOL•ISOPROPYL MYRISTATE•SD ALCOHOL 40-B•ISODODECANE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•TRIMETHYLSILOXYSILICATE•GLYCERIN•PEG/PPG-14/7 DIMETHYL ETHER•POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER•TREHALOSE•DEXTRIN PALMITATE•TOCOPHERYL ACETATE•POLYQUATERNIUM-51•SODIUM ACETYLATED HYALURONATE•DIPOTASSIUM GLYCYRRHIZATE•SAXIFRAGA SARMENTOSA EXTRACT•GINKGO BILOBA LEAF EXTRACT•THYMUS SERPILLUM EXTRACT•HYDROLYZED SILK•SCUTELLARIA BAICALENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•GARCINIA MANGOSTANA BARK EXTRACT•HIBISCUS SABDARIFFA FLOWER EXTRACT•PANAX GINSENG ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•HYDROGEN DIMETHICONE•ISOSTEARIC ACID•DISTEARDIMONIUM HECTORITE•TALC•HYDRATED SILICA•TRIETHOXYCAPRYLYLSILANE•ALCOHOL•TRISODIUM EDTA•CALCIUM STEARATE•DISTEARYLDIMONIUM CHLORIDE•STEARIC ACID•BHT•SILICA•THEANINE•METHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•IRON OXIDES•TITANIUM DIOXIDE•MICA•

Other information

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

clé de peau
BEAUTÉ

50+
WATER RESISTANT (80 MINUTES)

UV protective emulsion
very high protection
for body

BROAD SPECTRUM
SPF 50+
SUNSCREEN

75mL 2.5 FL. OZ.

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton
CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY 
octinoxate, octocrylene, titanium dioxide, and zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-289
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5678 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2302 mg  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1151 mg  in 75 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14808 mg  in 75 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISODODECANE (UNII: A8289P68Y2)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
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)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TALC (UNII: 7SEV7J4R1U)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALCOHOL (UNII: 3K9958V90M)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
CALCIUM STEARATE (UNII: 776XM7047L)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
THEANINE (UNII: 8021PR16QO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-289-101 in 1 CARTON02/01/2017
175 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2017
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132manufacture(58411-289) , analysis(58411-289)

Revised: 12/2018
Document Id: 7cf25316-216f-29bc-e053-2a91aa0ab049
Set id: 8e8ff21c-2372-46b5-8219-135716fe082b
Version: 2
Effective Time: 20181213
 
SHISEIDO AMERICAS CORPORATION