CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY- octinoxate, octocrylene, titanium dioxide, and zinc oxide emulsion

CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY by

Drug Labeling and Warnings

CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY 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
TITANIUM DIOXIDE 1.5%	Sunscreen
ZINC OXIDE 19.3%	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.

Flammable

Do not use near heat, flame, or while smoking

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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

DIMETHICONEWATERBUTYLENE GLYCOLISOPROPYL MYRISTATESD ALCOHOL 40-BISODODECANEPEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONETRIMETHYLSILOXYSILICATEGLYCERINPEG/PPG-14/7 DIMETHYL ETHERPOLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMERTREHALOSEDEXTRIN PALMITATETOCOPHERYL ACETATEPOLYQUATERNIUM-51SODIUM ACETYLATED HYALURONATEDIPOTASSIUM GLYCYRRHIZATESAXIFRAGA SARMENTOSA EXTRACTGINKGO BILOBA LEAF EXTRACTTHYMUS SERPILLUM EXTRACTHYDROLYZED SILKSCUTELLARIA BAICALENSIS ROOT EXTRACTUNCARIA GAMBIR EXTRACTGARCINIA MANGOSTANA BARK EXTRACTHIBISCUS SABDARIFFA FLOWER EXTRACTPANAX GINSENG ROOT EXTRACTHYDROLYZED CONCHIOLIN PROTEINHYDROGEN DIMETHICONEISOSTEARIC ACIDDISTEARDIMONIUM HECTORITETALCHYDRATED SILICATRIETHOXYCAPRYLYLSILANEALCOHOLTRISODIUM EDTACALCIUM STEARATEDISTEARYLDIMONIUM CHLORIDESTEARIC ACIDBHTSILICATHEANINEMETHYLPARABENPHENOXYETHANOLFRAGRANCEIRON 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 - 75 mL Bottle Carton

clé de peau
BEAUTÉ

50+
WATER RESISTANT (80 MINUTES)

UV protective emulsion
very high protection
for body

BROAD SPECTRUM
SPF 50+
SUNSCREEN

75mL 2.5 FL. OZ.

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVE VERY HIGH PROTECTION FOR BODY 
octinoxate, octocrylene, titanium dioxide, and zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5678 mg  in 75 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2302 mg  in 75 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1151 mg  in 75 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14808 mg  in 75 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISODODECANE (UNII: A8289P68Y2)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
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)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
ASIAN GINSENG (UNII: CUQ3A77YXI)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
ISOSTEARIC ACID (UNII: X33R8U0062)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TALC (UNII: 7SEV7J4R1U)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALCOHOL (UNII: 3K9958V90M)
EDETATE TRISODIUM (UNII: 420IP921MB)
CALCIUM STEARATE (UNII: 776XM7047L)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
STEARIC ACID (UNII: 4ELV7Z65AP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
THEANINE (UNII: 8021PR16QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-289-10	1 in 1 CARTON	02/01/2017
1		75 mL in 1 BOTTLE; 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(58411-289) , analysis(58411-289)