CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I - ensulizole, octinoxate, octocrylene and oxybenzone cream
SHISEIDO CO., LTD.

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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Drug Facts

Active ingredients	Purpose
ENSULIZOLE 1.5%	Sunscreen
OCTINOXATE 4.9%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
OXYBENZONE 1.0%	Sunscreen

Uses

helps prevent sunburn
higher SPF gives more sunburn protection

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

apply evenly before sun exposure and as needed.
children under 6 months of age: ask a doctor.

Inactive ingredients

WATER, ALCOHOL, DIPROPYLENE GLYCOL, GLYCERIN, XYLITOL, DIMETHICONE, HYDROGENATED POLYDECENE, TRIETHANOLAMINE, PPG-8 CETETH-20, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, XANTHAN GUM, TOCOPHERYL ACETATE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, GLYCYL GLYCINE, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF EXTRACT, PAEONIA SUFFRUTICOSA ROOT EXTRACT, ROSA ROXBURGHII FRUIT EXTRACT, HYDROLYZED CONCHIOLIN PROTEIN, HYPERICUM ERECTUM EXTRACT, HYDROLYZED SILK, BUPLEURUM FALCATUM ROOT EXTRACT, COIX LACRYMA-JOBI (JOB'S TEARS) SEED EXTRACT, CARBOMER, ISOSTEARIC ACID, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, BUTYLENE GLYCOL, BHT, SODIUM METABISULFITE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

Manufactured by
SHISEIDO CO., LTD.
7-5-5 GINZA TOKYO
MADE IN JAPAN

PRINCIPAL DISPLAY PANEL - 125mL Carton

clé de peau
BEAUTÉ

refreshing protective emulsion

SPF 20
sunscreen

125mL 4.2 FL. OZ.

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I
ensulizole, octinoxate, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-346
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (Ensulizole)	Ensulizole	1.90875 g in 127.25 g
Octinoxate (Octinoxate)	Octinoxate	6.23525 g in 127.25 g
Octocrylene (Octocrylene)	Octocrylene	3.8175 g in 127.25 g
Oxybenzone (Oxybenzone)	Oxybenzone	1.2725 g in 127.25 g

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL
DIPROPYLENE GLYCOL
GLYCERIN
XYLITOL
DIMETHICONE
TROLAMINE
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE, DL-
SERINE
DIGLYCINE
SAXIFRAGA STOLONIFERA LEAF
GINKGO
PAEONIA SUFFRUTICOSA ROOT
HYPERICUM ERECTUM FLOWERING TOP
BUPLEURUM FALCATUM ROOT
COIX LACRYMA-JOBI SEED
ISOSTEARIC ACID
EDETATE DISODIUM
BUTYLENE GLYCOL
BUTYLATED HYDROXYTOLUENE
SODIUM METABISULFITE
ALPHA-TOCOPHEROL
PHENOXYETHANOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:52685-346-10	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		127.25 g in 1 BOTTLE	This package is contained within the CARTON (52685-346-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	02/01/2011

Labeler - SHISEIDO CO., LTD. (690536453)

Establishment
Name	Address	ID/FEI	Operations
SHISEIDO CO., LTD.		690536453	MANUFACTURE, ANALYSIS

Revised: 06/2011 SHISEIDO CO., LTD.