NDC Code 49404-106-01 | pharmacompass.com

NDC Code(s) : 49404-106-01, 49404-106-02
Packager : Have and Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Renewalist BBTitanium Dioxide, Zinc Oxide CREAM

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:49404-106
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE(UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.704 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.891 mL in 30 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE(UNII: 92RU3N3Y1O)	1.8 mL in 30 mL
WATER(UNII: 059QF0KO0R)	11.06437 mL in 30 mL
Butylene Glycol Dicaprylate/Dicaprate(UNII: 75D21FL1PI)	1.8 mL in 30 mL
Propylene Glycol(UNII: 6DC9Q167V3)	1.8 mL in 30 mL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)	1.464 mL in 30 mL
ETHYLHEXYL OLEATE(UNII: R34927QY59)	0.9 mL in 30 mL
BABASSU OIL(UNII: 8QSB4M5477)	0.9 mL in 30 mL
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)	0.6 mL in 30 mL
NIACINAMIDE(UNII: 25X51I8RD4)	0.6 mL in 30 mL
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)	0.6 mL in 30 mL
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)	0.48 mL in 30 mL
SODIUM CHLORIDE(UNII: 451W47IQ8X)	0.36 mL in 30 mL
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)	0.306 mL in 30 mL
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)	0.3 mL in 30 mL
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)	0.297 mL in 30 mL
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)	0.297 mL in 30 mL
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)	0.229 mL in 30 mL
STEARIC ACID(UNII: 4ELV7Z65AP)	0.204 mL in 30 mL
CAPRYLYL GLYCOL(UNII: 00YIU5438U)	0.105 mL in 30 mL
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)	0.102 mL in 30 mL
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)	0.085 mL in 30 mL
HEXYL LAURATE(UNII: 4CG9F9W01Q)	0.084 mL in 30 mL
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)	0.06 mL in 30 mL
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)	0.046 mL in 30 mL
PHENOXYETHANOL(UNII: HIE492ZZ3T)	0.045 mL in 30 mL
ARGAN OIL(UNII: 4V59G5UW9X)	0.03 mL in 30 mL
CALCIUM STEARATE(UNII: 776XM7047L)	0.03 mL in 30 mL
CERESIN(UNII: Q1LS2UJO3A)	0.03 mL in 30 mL
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)	0.03 mL in 30 mL
JOJOBA OIL(UNII: 724GKU717M)	0.03 mL in 30 mL
MORINGA OLEIFERA SEED OIL(UNII: REM6A5QMC0)	0.0299 mL in 30 mL
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)	0.0256 mL in 30 mL
1,2-HEXANEDIOL(UNII: TR046Y3K1G)	0.015 mL in 30 mL
ADENOSINE(UNII: K72T3FS567)	0.012 mL in 30 mL
DISTEARYLDIMONIUM(UNII: 251IW5I21C)	0.0108 mL in 30 mL
EDETATE DISODIUM(UNII: 7FLD91C86K)	0.009 mL in 30 mL
PROPYLENE CARBONATE(UNII: 8D08K3S51E)	0.003 mL in 30 mL
ANGELICA KEISKEI TOP(UNII: AP628M4TQO)	0.00295 mL in 30 mL
LENTINULA EDODES MYCELIUM(UNII: CU2S39TB8O)	0.00295 mL in 30 mL
RICE GERM(UNII: 7N2B70SFEZ)	0.00295 mL in 30 mL
ASIAN GINSENG(UNII: CUQ3A77YXI)	0.00295 mL in 30 mL
PURSLANE(UNII: M6S840WXG5)	0.00295 mL in 30 mL
ROSEMARY(UNII: IJ67X351P9)	0.00295 mL in 30 mL
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)	0.00295 mL in 30 mL
ARBUTIN(UNII: C5INA23HXF)	0.000315 mL in 30 mL
N-ACETYL-TYROSINE(UNII: DA8G610ZO5)	0.00015 mL in 30 mL
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)	0.00013 mL in 30 mL
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)	0.000054 mL in 30 mL
TOCOPHEROL(UNII: R0ZB2556P8)	0.00003 mL in 30 mL

#	Item Code	Package Description
Packaging
1	NDC:49404-106-02	1 in 1 CARTON
1	NDC:49404-106-01	40 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	07/30/2012

NDC 49404-106-01
API & Excipient Details

marketed by Have and Be Co., Ltd. under NDC Code 49404-106-01

NDC Code(s) : 49404-106-01, 49404-106-02
Packager : Have and Be Co., Ltd.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 49404-106-01 API & Excipient Details

marketed by Have and Be Co., Ltd. under NDC Code 49404-106-01

NDC Code(s) : 49404-106-01, 49404-106-02Packager : Have and Be Co., Ltd.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

NDC 49404-106-01
API & Excipient Details

NDC Code(s) : 49404-106-01, 49404-106-02
Packager : Have and Be Co., Ltd.