CLE DE PEAU BEAUTE REFRESHING 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 REFRESHING PROTECTIVE EMULSION I

Drug Facts

Active ingredientsPurpose
ENSULIZOLE 1.5%Sunscreen
OCTINOXATE 4.9%Sunscreen
OCTOCRYLENE 5.0%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, HYDROGENATED POLYDECENE, TRIETHANOLAMINE, PPG-8 CETETH-20, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, XANTHAN GUM, TOCOPHERYL ACETATE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, GLYCYL GLYCINE, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, PAEONIA SUFFRUTICOSA ROOT 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, CARBOMER, ISOSTEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, BUTYLENE GLYCOL, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO
MADE IN JAPAN

PRINCIPAL DISPLAY PANEL - 125mL Carton

clé de peau
BEAUTÉ

refreshing protective emulsion

SPF 20
sunscreen

125mL 4.2 FL. OZ.

Principal Display Panel - 125mL Carton
CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I 
ensulizole, octinoxate, octocrylene, and oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52685-346
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42) Ensulizole1.90875 g  in 127.25 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate6.23525 g  in 127.25 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene3.8175 g  in 127.25 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone1.2725 g  in 127.25 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TROLAMINE (UNII: 9O3K93S3TK)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
SERINE (UNII: 452VLY9402)  
DIGLYCINE (UNII: 10525P22U0)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
GINKGO (UNII: 19FUJ2C58T)  
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
COIX LACRYMA-JOBI SEED (UNII: 4Q4V6NTZ1F)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52685-346-101 in 1 CARTON02/01/201103/01/2019
1127.25 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(52685-346) , ANALYSIS(52685-346)

Revised: 9/2023
Document Id: cbf263e9-f299-493a-ba29-95b1a2a8089d
Set id: b98d0003-8583-429a-a6f1-cbdefd797e8a
Version: 4
Effective Time: 20230920
 
SHISEIDO CO., LTD.