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

CLE DE PEAU BEAUTE REFRESHING PROTECTIVE I by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE REFRESHING 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 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

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ensulizole (UNII: 9YQ9DI1W42) (Ensulizole - UNII:9YQ9DI1W42)	Ensulizole	1.90875 g  in 127.25 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	6.23525 g  in 127.25 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	3.8175 g  in 127.25 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	1.2725 g  in 127.25 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)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SERINE (UNII: 452VLY9402)
DIGLYCINE (UNII: 10525P22U0)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
COIX LACRYMA-JOBI SEED (UNII: 4Q4V6NTZ1F)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52685-346-10	1 in 1 CARTON
1		127.25 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(52685-346) , ANALYSIS(52685-346)