NDC Code(s) : 58411-291-60
Packager : SHISEIDO AMERICAS CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLE DE PEAU BEAUTE UV PROTECTIVEOCTINOXATE, OCTOCRYLENE, and ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58411-291
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3870 mg in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1569 mg in 50 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE8577 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
1NDC:58411-291-601 in 1 CARTON 02/01/2017
150 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)

PRINCIPAL DISPLAY PANEL

clé de peau
BEAUTÉ

50+

UV protective cream

BROAD SPECTRUM
SPF 50+
SUNSCREEN

50mL NET WT. 2.1 OZ.

Principal Display Panel - 50 mL Tube Carton