CLE DE PEAU BEAUTE UV PROTECTION- octinoxate, octocrylene, oxybenzone, and zinc oxide cream

CLE DE PEAU BEAUTE UV PROTECTION by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE UV PROTECTION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICA INC., Davlyn Industries Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 3.0%	Sunscreen
OXYBENZONE 1.5%	Sunscreen
ZINC OXIDE 9.0%	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 BUTYLENE GLYCOL ISOHEXADECANE DIMETHICONE ISOPROPYL MYRISTATE GLYCERIN POLYMETHYLSILSESQUIOXANE SD ALCOHOL 40-B LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DISTEARDIMONIUM HECTORITE POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER PEG-6 XYLITOL PEG-32 SODIUM HYALURONATE TOCOPHERYL ACETATE LACTOBACILLUS/HIBISCUS SABDARIFFA FLOWER FERMENT FILTRATE CRATAEGUS MONOGYNA FLOWER EXTRACT THIOTAURINE DIPOTASSIUM GLYCYRRHIZATE 2-O-ETHYL ASCORBIC ACID SODIUM ACETYLATED HYALURONATE POLYQUATERNIUM-51 SAXIFRAGA SARMENTOSA EXTRACT UNCARIA GAMBIR EXTRACT GINKGO BILOBA LEAF EXTRACT THYMUS SERPILLUM EXTRACT ROSA ROXBURGHII FRUIT EXTRACT HYDROLYZED CONCHIOLIN PROTEIN CURCUMA LONGA (TURMERIC) ROOT EXTRACT HYPERICUM ERECTUM EXTRACT HYDROLYZED SILK BUPLEURUM FALCATUM ROOT EXTRACT HYDROGENATED POLYDECENE SILICA ISOSTEARIC ACID HYDROGEN DIMETHICONE TRISODIUM EDTA BHT ALCOHOL TOCOPHEROL PHENOXYETHANOL FRAGRANCE TITANIUM DIOXIDE MICA

Questions?

1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Carton

clé de peau

BEAUTÉ

SPF
50
PA+++
sunscreen

UV protection cream

50mL NET WT. 1.9 OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTION 
octinoxate, octocrylene, oxybenzone, and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-259
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	4.06 g  in 54.91 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	1.65 g  in 54.91 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	0.82 g  in 54.91 g
Zinc oxide (UNII: SOI2LOH54Z) (Zinc oxide - UNII:SOI2LOH54Z)	Zinc oxide	4.94 g  in 54.91 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
XYLITOL (UNII: VCQ006KQ1E)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
THIOTAURINE (UNII: NQZ2D7AO62)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
TURMERIC (UNII: 856YO1Z64F)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE TRISODIUM (UNII: 420IP921MB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ALCOHOL (UNII: 3K9958V90M)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-259-60	1 in 1 CARTON
1		54.91 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2012

Labeler - SHISEIDO AMERICA INC. (782677132)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	MANUFACTURE(52686-259) , ANALYSIS(52686-259)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-259)