CLE DE PEAU BEAUTE UV PROTECTION- octinoxate, octocrylene, oxybenzone, and zinc oxide cream 
SHISEIDO AMERICA INC.

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CLE DE PEAU BEAUTE UV PROTECTION
CREAM

Drug Facts

Active ingredientsPurpose
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 3.0%Sunscreen
OXYBENZONE 1.5%Sunscreen
ZINC OXIDE 9.0%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 • BUTYLENE GLYCOL • ISOHEXADECANE • DIMETHICONE • ISOPROPYL MYRISTATE • GLYCERIN • POLYMETHYLSILSESQUIOXANE • SD ALCOHOL 40-B • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DISTEARDIMONIUM HECTORITE • POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER • PEG-6 • XYLITOL • PEG-32 • SODIUM HYALURONATE • TOCOPHERYL ACETATE • LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE • CRATAEGUS MONOGYNA FLOWER EXTRACT • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • 2-O-ETHYL ASCORBIC ACID • SODIUM ACETYLATED HYALURONATE • POLYQUATERNIUM-51 • SAXIFRAGA SARMENTOSA EXTRACT • UNCARIA GAMBIR EXTRACT • GINKGO BILOBA LEAF EXTRACT • THYMUS SERPILLUM EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • CURCUMA LONGA (TURMERIC) ROOT EXTRACT • HYPERICUM ERECTUM EXTRACT • HYDROLYZED SILK • BUPLEURUM FALCATUM ROOT EXTRACT • HYDROGENATED POLYDECENE • SILICA • ISOSTEARIC ACID • HYDROGEN DIMETHICONE • TRISODIUM EDTA • BHT • ALCOHOL • TOCOPHEROL • PHENOXYETHANOL • FRAGRANCE • TITANIUM DIOXIDE • MICA •

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Carton

clé de peau

BEAUTÉ

SPF
50
PA+++
sunscreen

UV protection cream

50mL NET WT. 1.9 OZ.

Principal Display Panel - 50 mL Carton
CLE DE PEAU BEAUTE UV PROTECTION 
octinoxate, octocrylene, oxybenzone, and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52686-259
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate4.06 g  in 54.91 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene1.65 g  in 54.91 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.82 g  in 54.91 g
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide4.94 g  in 54.91 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
XYLITOL (UNII: VCQ006KQ1E)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
THIOTAURINE (UNII: NQZ2D7AO62)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)  
GINKGO (UNII: 19FUJ2C58T)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
TURMERIC (UNII: 856YO1Z64F)  
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ALCOHOL (UNII: 3K9958V90M)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52686-259-601 in 1 CARTON03/01/201206/11/2012
154.91 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugMonographID03/01/201206/11/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICA INC.782677132MANUFACTURE(52686-259) , ANALYSIS(52686-259)
Establishment
NameAddressID/FEIBusiness Operations
Davlyn Industries Inc624436254MANUFACTURE(52686-259)

Revised: 10/2023
 
SHISEIDO AMERICA INC.