NDC Code(s) : 49404-121-01, 49404-121-02
Packager : Have and Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Premium Beauty Balm 02Titanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-121
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 DIOXIDE3.606 mg in 40 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.522 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
DIMETHICONE(UNII: 92RU3N3Y1O)
ARBUTIN(UNII: C5INA23HXF)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE(UNII: 13P836X9Q6)
MAGNESIUM SULFATE(UNII: DE08037SAB)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
CALCIUM STEARATE(UNII: 776XM7047L)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TALC(UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ADENOSINE(UNII: K72T3FS567)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
NEPIDERMIN(UNII: TZK30RF92W)
SOYBEAN OIL(UNII: 241ATL177A)
STEARETH-20(UNII: L0Q8IK9E08)
CHRYSIN(UNII: 3CN01F5ZJ5)
N-HYDROXYSUCCINIMIDE(UNII: MJE3791M4T)
PALMITOYL TRIPEPTIDE-5(UNII: 2A3916MQHO)
PALMITOYL TETRAPEPTIDE-7(UNII: Q41S464P1R)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-121-021 in 1 CARTON 30/10/2014
1NDC:49404-121-0140 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 10/30/2014

PRINCIPAL DISPLAY PANEL

Premium Beauty Balm