NDC Code(s) : 49404-127-01, 49404-127-02
Packager : Have & Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr. Jart Illuminating BB BrushTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-127
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 DIOXIDE1.68 mg in 40 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2 mg in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.96 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)(UNII: V2W71V8T0X)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
MICA(UNII: V8A1AW0880)
GLYCERIN(UNII: PDC6A3C0OX)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST)(UNII: P0TX083987)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
SORBITAN OLIVATE(UNII: MDL271E3GR)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
YELLOW WAX(UNII: 2ZA36H0S2V)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
CANANGA ODORATA FLOWER(UNII: 76GTF6Z97M)
STANNIC OXIDE(UNII: KM7N50LOS6)
LAVENDER OIL(UNII: ZBP1YXW0H8)
ROSEMARY OIL(UNII: 8LGU7VM393)
MENTHA X ROTUNDIFOLIA LEAF(UNII: K59TXG2L3U)
CHAMOMILE FLOWER OIL(UNII: 60F80Z61A9)
PEPPERMINT OIL(UNII: AV092KU4JH)
HIBISCUS SABDARIFFA FLOWER(UNII: 45TGG6IU6M)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
ARGANIA SPINOSA SEED(UNII: 8H7X7XB54H)
SODIUM COCOYL GLUTAMATE(UNII: BMT4RCZ3HG)
ROSA MULTIFLORA FRUIT(UNII: EZ5DSL4T27)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
PROPYL GALLATE(UNII: 8D4SNN7V92)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-127-021 in 1 CARTON 01/04/2016
1NDC:49404-127-0140 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 01/04/2016

PRINCIPAL DISPLAY PANEL

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