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

CLE DE PEAU BEAUTE CORRECTING VEIL n by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE CORRECTING VEIL n by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICAS INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Ensulizole 1.0%	Sunscreen
Octinoxate 2.9%	Sunscreen
Titanium Dioxide 2.4	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: ask a doctor

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.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.386 g  in 37 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.119 g  in 37 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.9264 g  in 37 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-483-10	1 in 1 CARTON	03/01/2020
1		37 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2020

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICAS INC.		782677132	MANUFACTURE(58411-483) , ANALYSIS(58411-483)