CLE DE PEAU BEAUTE CORRECTING VEIL N: Package Insert and Label Information

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.

Drug Facts

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.

PRINCIPAL DISPLAY PANEL -- 37 mL Bottle Carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 0.386 g in 37 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.119 g in 37 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 0.9264 g in 37 mL
Inactive Ingredients
Ingredient Name Strength
WATER
DIMETHICONE
BUTYLENE GLYCOL
GLYCERIN
ISOHEXADECANE
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
NYLON-12
TRIISOSTEARIN
DISTEARDIMONIUM HECTORITE
ERYTHRITOL
CETYL ETHYLHEXANOATE
XYLITOL
SILICON DIOXIDE
ISODECYL NEOPENTANOATE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
TREHALOSE
GLYCINE
PEG/PPG-14/7 DIMETHYL ETHER
ROSA ROXBURGHII FRUIT
ANGELICA ACUTILOBA ROOT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
PERILLA FRUTESCENS LEAF
TROLAMINE
ISOSTEARIC ACID
ALUMINUM HYDROXIDE
STEARIC ACID
EDETATE DISODIUM
BUTYLATED HYDROXYTOLUENE
.ALPHA.-TOCOPHEROL
TRIETHOXYCAPRYLYLSILANE
SODIUM CITRATE, UNSPECIFIED FORM
BARIUM SULFATE
THEANINE
CITRIC ACID MONOHYDRATE
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58411-483-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 37 mL in 1 BOTTLE This package is contained within the CARTON (58411-483-10)
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 Operations
SHISEIDO AMERICAS INC. 782677132 MANUFACTURE (58411-483), ANALYSIS (58411-483)

Revised: 10/2019 SHISEIDO AMERICAS CORPORATION

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