NDC Code(s) : 71026-005-01, 71026-005-02
Packager : YADAH Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

YADAH TWIN ANGEL BBTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71026-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE95.4 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE48.6 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION28.6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
GLYCERIN(UNII: PDC6A3C0OX)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
NIACINAMIDE(UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
CERESIN(UNII: Q1LS2UJO3A)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
CASTOR OIL(UNII: D5340Y2I9G)
YELLOW WAX(UNII: 2ZA36H0S2V)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
DIGLYCERYL SEBACATE/ISOPALMITATE(UNII: XK79T95N8Z)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
MICA(UNII: V8A1AW0880)
DIMETHICONOL (40 CST)(UNII: 343C7U75XW)
PHYTOSTERYL ISOSTEARYL DIMER DILINOLEATE(UNII: MRH313IE85)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
DIMETHICONE(UNII: 92RU3N3Y1O)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
EDETATE DISODIUM(UNII: 7FLD91C86K)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
ADENOSINE(UNII: K72T3FS567)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POLYGLYCERYL-2 TRIISOSTEARATE(UNII: 68DUY2D39A)
D&C RED NO. 7(UNII: ECW0LZ41X8)
METHICONE (20 CST)(UNII: 6777U11MKT)
D&C RED NO. 6(UNII: 481744AI4O)
POLYGLYCERYL-2 DIISOSTEARATE(UNII: DG195GP57P)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PURSLANE(UNII: M6S840WXG5)
MANGIFERA INDICA SEED BUTTER(UNII: 4OXD9M35X2)
SHEA BUTTER(UNII: K49155WL9Y)
TRIBASIC CALCIUM PHOSPHATE(UNII: 91D9GV0Z28)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
SELENICEREUS GRANDIFLORUS FLOWER(UNII: II877K4UNR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71026-005-021 in 1 CARTON 08/02/2017
1NDC:71026-005-0140 mL in 1 CONTAINER 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 08/02/2017

PRINCIPAL DISPLAY PANEL

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