CLE DE PEAU BEAUTE CORRECTING VEIL N- ensulizole, octinoxate, and titanium dioxide cream 
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 CORRECTING CREAM VEIL n

Drug Facts

Active ingredientsPurpose
Ensulizole 1.0%Sunscreen
Octinoxate 2.9%Sunscreen
Titanium Dioxide 2.4Sunscreen

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.

Directions

For sunscreen use:

Inactive Ingredients

WATER▪DIMETHICONE▪BUTYLENE GLYCOL▪GLYCERIN▪ISOHEXADECANE▪SD ALCOHOL 40-B▪POLYMETHYLSILSESQUIOXANE▪PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE▪NYLON-12▪TRIISOSTEARIN▪DISTEARDIMONIUM HECTORITE▪ERYTHRITOL▪CETYL ETHYLHEXANOATE▪XYLITOL▪SILICA▪ISODECYL NEOPENTANOATE▪TRIMETHYLSILOXYSILICATE▪TREHALOSE▪GLYCINE▪PEG/PPG-14/7 DIMETHYL ETHER▪ROSA ROXBURGHII FRUIT EXTRACT▪ANGELICA ACUTILOBA ROOT EXTRACT▪HYDROLYZED CONCHIOLIN PROTEIN▪HYDROLYZED SILK▪DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER▪PERILLA OCYMOIDES LEAF EXTRACT▪TRIETHANOLAMINE▪ISOSTEARIC ACID▪ALUMINUM HYDROXIDE▪STEARIC ACID▪DISODIUM EDTA▪BHT▪POLYSILICONE-2▪TOCOPHEROL▪TRIETHOXYCAPRYLYLSILANE▪SODIUM CITRATE▪BARIUM SULFATE▪THEANINE▪CITRIC ACID▪METHYL METHACRYLATE CROSSPOLYMER▪PHENOXYETHANOL▪FRAGRANCE▪TITANIUM DIOXIDE▪IRON OXIDES▪MICA▪

Other information

Protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 37 mL Bottle Carton

clé de peau

BEAUTÉ

CORRECTING
CREAM VEIL n

BROAD SPECTRUM
SPF 21
SUNSCREEN

37mL NET WT. 1.4 OZ.

PRINCIPAL DISPLAY PANEL - 37 mL Bottle Carton
CLE DE PEAU BEAUTE CORRECTING VEIL N 
ensulizole, octinoxate, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-483
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE0.386 g  in 37 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.119 g  in 37 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.9264 g  in 37 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
NYLON-12 (UNII: 446U8J075B)  
TRIISOSTEARIN (UNII: 71503RH8KG)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ERYTHRITOL (UNII: RA96B954X6)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
XYLITOL (UNII: VCQ006KQ1E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
TREHALOSE (UNII: B8WCK70T7I)  
GLYCINE (UNII: TE7660XO1C)  
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
TROLAMINE (UNII: 9O3K93S3TK)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
BARIUM SULFATE (UNII: 25BB7EKE2E)  
THEANINE (UNII: 8021PR16QO)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58411-483-101 in 1 CARTON03/01/2020
137 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 FINALpart35203/01/2020
Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
Establishment
NameAddressID/FEIBusiness Operations
SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-483) , ANALYSIS(58411-483)

Revised: 10/2019
Document Id: caf0c559-abea-48a9-94cb-dc67d71e1a73
Set id: fd9b42e4-6f9d-45a9-bee3-ac1bc4b35252
Version: 1
Effective Time: 20191018
 
SHISEIDO AMERICAS CORPORATION