CLE DE PEAU BEAUTE UV PROTECTION- octinoxate, octocrylene, 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
ZINC OXIDE 16.4%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

Inactive Ingredients

WATER, DIPROPYLENE GLYCOL, ISOHEXADECANE, DIMETHICONE, ISOPROPYL MYRISTATE, GLYCERIN, SD ALCOHOL 40-B, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, POLYMETHYL METHACRYLATE, POLYMETHYLSILSESQUIOXANE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, DISTEARDIMONIUM HECTORITE, PEG-6, PEG-32, SILICA, XYLITOL, 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, HYDROGEN DIMETHICONE, ISOSTEARIC ACID, TRISODIUM EDTA, BUTYLENE GLYCOL, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE, MICA,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

clé de peau
BEAUTÉ

50+

UV protection cream

BROAD SPECTRUM
SPF 50+
SUNSCREEN

50mL NET WT. 2.0 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52686-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4348 mg  in 58.75 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1763 mg  in 58.75 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9635 mg  in 58.75 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
ALCOHOL (UNII: 3K9958V90M)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
THIOTAURINE (UNII: NQZ2D7AO62)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
TURMERIC (UNII: 856YO1Z64F)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52686-275-60	1 in 1 CARTON
1		58.75 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(52686-275) , ANALYSIS(52686-275)

Establishment
Name	Address	ID/FEI	Business Operations
Davlyn Industries Inc		624436254	MANUFACTURE(52686-275)