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

CLE DE PEAU BEAUTE GENTLE PROTECTIVE I by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE GENTLE PROTECTIVE I by is a Otc medication manufactured, distributed, or labeled by SHISEIDO CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	1.92 g  in 128 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.272 g  in 128 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	3.84 g  in 128 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.28 g  in 128 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
DIGLYCINE (UNII: 10525P22U0)
SERINE (UNII: 452VLY9402)
GINKGO (UNII: 19FUJ2C58T)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BEHENIC ACID (UNII: H390488X0A)
STEARIC ACID (UNII: 4ELV7Z65AP)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BATILOL (UNII: 39YR661C4U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-347-10	1 in 1 CARTON
1		128 g in 1 BOTTLE

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	Business Operations
SHISEIDO CO., LTD.		695087684	MANUFACTURE(52685-347) , ANALYSIS(52685-347)