NDC Code(s) : 49404-101-01, 49404-101-02
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 BalmTitanium Dioxide, Zinc Oxide EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-101
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)
DIMETHICONE(UNII: 92RU3N3Y1O)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
Dipropylene Glycol(UNII: E107L85C40)
Arbutin(UNII: C5INA23HXF)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MAGNESIUM SULFATE, UNSPECIFIED(UNII: DE08037SAB)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Stearic Acid(UNII: 4ELV7Z65AP)
CALCIUM STEARATE(UNII: 776XM7047L)
HECTORITE(UNII: 08X4KI73EZ)
Propylene Carbonate(UNII: 8D08K3S51E)
Polysorbate 80(UNII: 6OZP39ZG8H)
Propylene Glycol(UNII: 6DC9Q167V3)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
Talc(UNII: 7SEV7J4R1U)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
ADENOSINE(UNII: K72T3FS567)
Alcohol(UNII: 3K9958V90M)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
HUMAN EPIDERMAL GROWTH FACTOR (UNII: TZK30RF92W)
GLYCINE(UNII: TE7660XO1C)
POVIDONE K30(UNII: U725QWY32X)
Platinum(UNII: 49DFR088MY)
Steareth-20(UNII: L0Q8IK9E08)
CHRYSIN(UNII: 3CN01F5ZJ5)
N-HYDROXYSUCCINIMIDE(UNII: MJE3791M4T)
palmitic acid(UNII: 2V16EO95H1)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Phenoxyethanol(UNII: HIE492ZZ3T)
Methylparaben(UNII: A2I8C7HI9T)
Butylparaben(UNII: 3QPI1U3FV8)
Propylparaben(UNII: Z8IX2SC1OH)
Iron(UNII: E1UOL152H7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-101-021 in 1 CARTON 11/01/2010
1NDC:49404-101-0140 mL in 1 TUBE 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 11/01/2010

PRINCIPAL DISPLAY PANEL

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