CLE DE PEAU BEAUTE GENTLE 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 3.0%	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, ISODODECANE, TRIETHYLHEXANOIN, HYDROGENATED POLYDECENE, PEG-5 GLYCERYL STEARATE, ISOSTEARIC ACID, SILICA, DIPHENYLSILOXY PHENYL TRIMETHICONE, XANTHAN GUM, PEG/PPG-17/4 DIMETHYL ETHER, PHYTOSTERYL MACADAMIATE, TOCOPHERYL ACETATE, GLYCYL GLYCINE, CRATAEGUS MONOGINA FLOWER EXTRACT, SERINE, 2-O-ETHYL ASCORBIC ACID, SODIUM ACETYLATED HYALURONATE, POLYQUATERNIUM-51, SAXIFRAGA SARMENTOSA EXTRACT, UNCARIA GAMBIR EXTRACT, GINKGO BILOBA LEAF 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, SODIUM MAGNESIUM SILICATE, GLYCERYL STEARATE SE, BEHENIC ACID, STEARIC ACID, BEHENYL ALCOHOL, SODIUM HYDROXIDE, BATYL ALCOHOL, PEG-30 SOY STEROL, DISODIUM EDTA, CELLULOSE GUM, SODIUM METAPHOSPHATE, BUTYLENE GLYCOL, BHT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 125 mL Bottle Carton

clé de peau
BEAUTÉ

gentle protective emulsion
SPF 20
sunscreen

125mL 4.2 FL. OZ.

Principal Display Panel - 125 mL Bottle Carton

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52685-347
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (Ensulizole)	Ensulizole	1.92 g in 128 g
Octinoxate (Octinoxate)	Octinoxate	6.272 g in 128 g
Octocrylene (Octocrylene)	Octocrylene	3.84 g in 128 g
Oxybenzone (Oxybenzone)	Oxybenzone	1.28 g in 128 g

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL
DIPROPYLENE GLYCOL
GLYCERIN
XYLITOL
DIMETHICONE
ISODODECANE
TRIETHYLHEXANOIN
ISOSTEARIC ACID
SILICON DIOXIDE
XANTHAN GUM
.ALPHA.-TOCOPHEROL ACETATE, DL-
DIGLYCINE
SERINE
GINKGO
HYPERICUM ERECTUM FLOWERING TOP
GLYCERYL MONOSTEARATE
DOCOSANOIC ACID
STEARIC ACID
DOCOSANOL
SODIUM HYDROXIDE
BATILOL
EDETATE DISODIUM
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM POLYMETAPHOSPHATE
BUTYLENE GLYCOL
BUTYLATED HYDROXYTOLUENE
ALPHA-TOCOPHEROL
PHENOXYETHANOL

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:52685-347-10	1 BOTTLE ( BOTTLE) in 1 CARTON	contains a BOTTLE
1		128 g in 1 BOTTLE	This package is contained within the CARTON (52685-347-10)

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.