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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.704 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.891 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
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
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-106-021 in 1 CARTON
1NDC:49404-106-0140 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/30/2012

PRINCIPAL DISPLAY PANEL

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