NDC Code(s) : 49404-107-01, 49404-107-02
Packager : Have and Be Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dr.Jart Black Label Detox BB Beaty Balm Titanium Dioxide, Zinc Oxide EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49404-107
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 dioxide3.8132 mg in 40 mL
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide1.536 mg in 40 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
Butylene Glycol(UNII: 3XUS85K0RA)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
Glycerin(UNII: PDC6A3C0OX)
Sodium Chloride(UNII: 451W47IQ8X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Arbutin(UNII: C5INA23HXF)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DISTEARYLDIMONIUM(UNII: 251IW5I21C)
Calcium Stearate(UNII: 776XM7047L)
DIMETHICONE(UNII: 92RU3N3Y1O)
Talc(UNII: 7SEV7J4R1U)
Sorbitan Olivate(UNII: MDL271E3GR)
Caprylyl Glycol(UNII: 00YIU5438U)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
Hexyl Laurate(UNII: 4CG9F9W01Q)
Propylene Carbonate(UNII: 8D08K3S51E)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
Phenoxyethanol(UNII: HIE492ZZ3T)
Ethylhexylglycerin(UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYDROGEN(UNII: 7YNJ3PO35Z)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Sorbitan Isostearate(UNII: 01S2G2C1E4)
Diisostearyl Malate(UNII: QBS8A3XZGQ)
YELLOW WAX(UNII: 2ZA36H0S2V)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
EDETATE DISODIUM(UNII: 7FLD91C86K)
UBIDECARENONE(UNII: EJ27X76M46)
CHAMAEMELUM NOBILE FLOWER(UNII: O2T154T6OG)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAVIAR, UNSPECIFIED(UNII: 020K6HLU0O)
Propylene Glycol(UNII: 6DC9Q167V3)
PURSLANE(UNII: M6S840WXG5)
Alcohol(UNII: 3K9958V90M)
GINKGO(UNII: 19FUJ2C58T)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
Glyceryl Caprylate(UNII: TM2TZD4G4A)
Potassium sorbate(UNII: 1VPU26JZZ4)
Sodium Benzoate(UNII: OJ245FE5EU)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49404-107-021 in 1 CARTON 09/01/2012
1NDC:49404-107-0140 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 09/01/2012

PRINCIPAL DISPLAY PANEL

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