CLE DE PEAU BEAUTE CORRECTING VEIL N M- ensulizole, octinoxate, and zinc oxide cream

cle de peau BEAUTE CORRECTING VEIL n M by

Drug Labeling and Warnings

cle de peau BEAUTE CORRECTING VEIL n M by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, Shiseido America 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 3.9%	Sunscreen
ZINC OXIDE 9.7%	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∙ISODECYL NEOPENTANOATE∙SD ALCOHOL 40-B∙POLYMETHYLSILSESQUIOXANE∙CETYL ETHYLHEXANOATE∙PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙NYLON-12∙TRIISOSTEARIN∙DISTEARDIMONIUM HECTORITE∙ERYTHRITOL∙XYLITOL∙SILICA∙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∙HYDROGEN DIMETHICONE∙DISODIUM EDTA∙ETHYLHEXYLGLYCERIN∙ALUMINUM HYDROXIDE∙BHT∙POLYSILICONE-2∙TOCOPHEROL∙TRIETHOXYCAPRYLYLSILANE∙SODIUM CITRATE∙SODIUM METABISULFITE∙BARIUM SULFATE∙THEANINE∙CITRIC ACID∙METHYL METHACRYLATE CROSSPOLYMER∙CHLORPHENESIN∙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 Tube 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 M 
ensulizole, octinoxate, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-892
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	0.40552 g  in 37 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.581528 g  in 37 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.933544 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)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALCOHOL (UNII: 3K9958V90M)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
NYLON-12 (UNII: 446U8J075B)
TRIISOSTEARIN (UNII: 71503RH8KG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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 (HARD PARTICLE) (UNII: H895X08VNQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
TROLAMINE (UNII: 9O3K93S3TK)
ISOSTEARIC ACID (UNII: X33R8U0062)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
BARIUM SULFATE (UNII: 25BB7EKE2E)
THEANINE (UNII: 8021PR16QO)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-892-60	1 in 1 CARTON	03/04/2025
1		37 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	03/04/2025

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Registrant - Shiseido America Inc. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
Shiseido America Inc.		782677132	ANALYSIS(58411-892) , MANUFACTURE(58411-892)