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

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 UV PROTECTION
CREAM

Drug Facts

Active ingredients Purpose
OCTINOXATE 7.4% Sunscreen
OCTOCRYLENE 3.0% Sunscreen
OXYBENZONE 1.5% Sunscreen
ZINC OXIDE 9.0% Sunscreen

Uses

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:52686-259
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 4.06 g  in 54.91 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 1.65 g  in 54.91 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.82 g  in 54.91 g
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z) Zinc oxide 4.94 g  in 54.91 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:52686-259-60 1 in 1 CARTON
1 54.91 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 03/01/2012
Labeler - SHISEIDO AMERICA INC. (782677132)
Establishment
Name Address ID/FEI Business Operations
SHISEIDO AMERICA INC. 782677132 MANUFACTURE(52686-259) , ANALYSIS(52686-259)
Establishment
Name Address ID/FEI Business Operations
Davlyn Industries Inc 624436254 MANUFACTURE(52686-259)

Revised: 2/2012
Document Id: 177f1296-f84a-40f1-9b0a-77d3f5f70649
Set id: ab689c4a-e276-4c6f-9d0d-97ce06e9332d
Version: 1
Effective Time: 20120224
 
SHISEIDO AMERICA INC.