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

CLE DE PEAU BEAUTE UV PROTECTIVE by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE UV PROTECTIVE by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA 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

• 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

WATERDIPROPYLENE GLYCOLISOHEXADECANEISOPROPYL MYRISTATEGLYCERINSD ALCOHOL 40-BLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONEDIMETHICONEPOLYMETHYL METHACRYLATEDISTEARDIMONIUM HECTORITEPOLYMETHYLSILSESQUIOXANEPEG/PPG-14/7 DIMETHYL ETHERPOLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMERMACADAMIA SEED OIL POLYGLYCERYL-6 ESTERS BEHENATEPEG-6PEG-32SILICATREHALOSETOCOPHERYL ACETATEPOLYQUATERNIUM-51SODIUM ACETYLATED HYALURONATEDIPOTASSIUM GLYCYRRHIZATESAXIFRAGA SARMENTOSA EXTRACTGINKGO BILOBA LEAF EXTRACTTHYMUS SERPILLUM EXTRACTCRATAEGUS MONOGYNA FLOWER EXTRACTHYDROLYZED SILK2-O-ETHYL ASCORBIC ACIDSCUTELLARIA BAICALENSIS ROOT EXTRACTUNCARIA GAMBIR EXTRACTGARCINIA MANGOSTANA BARK EXTRACTHIBISCUS SABDARIFFA FLOWER EXTRACTPANAX GINSENG ROOT EXTRACTBUPLEURUM FALCATUM ROOT EXTRACTHYDROLYZED CONCHIOLIN PROTEINHYDROGENATED POLYDECENEHYDROGEN DIMETHICONEISOSTEARIC ACIDBUTYLENE GLYCOLTRISODIUM EDTATALCALCOHOLBHTTOCOPHEROLTRIETHOXYCAPRYLYLSILANETHEANINEPHENOXYETHANOLFRAGRANCEIRON OXIDESTITANIUM DIOXIDEMICA

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 protective cream

BROAD SPECTRUM
SPF 50+
SUNSCREEN

50mL NET WT. 2.1 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-291
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3870 mg  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1569 mg  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8577 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TREHALOSE (UNII: B8WCK70T7I)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
GINKGO (UNII: 19FUJ2C58T)
THYMUS SERPYLLUM (UNII: 86H4S6K51N)
CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOSTEARIC ACID (UNII: X33R8U0062)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE TRISODIUM (UNII: 420IP921MB)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
THEANINE (UNII: 8021PR16QO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
ISOHEXADECANE (UNII: 918X1OUF1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-291-60	1 in 1 CARTON	02/01/2017
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2017

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-291) , analysis(58411-291)