CLE DE PEAU BEAUTE GENTLE PROTECTIVE I- ensulizole, octinoxate, octocrylene, and oxybenzone cream 
SHISEIDO CO., LTD.

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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cle de peau BEAUTE GENTLE PROTECTIVE EMULSION I

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 1.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 1.0%Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection

Warnings

For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply evenly before sun exposure and as needed.
  • children under 6 months of age: ask a doctor.

Inactive ingredients

WATER, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, ISODODECANE, TRIETHYLHEXANOIN, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, GLYCYL GLYCINE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI (JOB'S TEARS) SEED EXTRACT, SODIUM MAGNESIUM SILICATE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, SODIUM HYDROXIDE, BATYL ALCOHOL, PEG-30 SOY STEROL, DISODIUM EDTA, CELLULOSE GUM, SODIUM METAPHOSPHATE, BUTYLENE GLYCOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton

clé de peau
BEAUTÉ

gentle protective emulsion
SPF 20
sunscreen

125mL 4.2 FL. OZ.

Principal Display Panel - 125 mL Bottle Carton
CLE DE PEAU BEAUTE GENTLE PROTECTIVE I 
ensulizole, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-347
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole1.92 g  in 128 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.272 g  in 128 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene3.84 g  in 128 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.28 g  in 128 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
DIGLYCINE (UNII: 10525P22U0)  
SERINE (UNII: 452VLY9402)  
GINKGO (UNII: 19FUJ2C58T)  
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BEHENIC ACID (UNII: H390488X0A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DOCOSANOL (UNII: 9G1OE216XY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
BATILOL (UNII: 39YR661C4U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-347-101 in 1 CARTON02/01/201103/01/2019
1128 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/01/201103/01/2019
Labeler - SHISEIDO CO., LTD. (690536453)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO CO., LTD.695087684MANUFACTURE(52685-347) , ANALYSIS(52685-347)

Revised: 9/2023
 
SHISEIDO CO., LTD.