NDC Code(s) : 59078-107-02
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY BCDation All MasterTitanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-107
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.72 g in 50 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.2 g in 50 g
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN0.8 g in 50 g
Inactive Ingredients
Ingredient Name Strength
SHEA BUTTER(UNII: K49155WL9Y)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ANEMARRHENA ASPHODELOIDES ROOT(UNII: U0OC9BJL0I)
ADANSONIA DIGITATA SEED OIL(UNII: 77MKL7AR5I)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
MICA(UNII: V8A1AW0880)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
GELATIN(UNII: 2G86QN327L)
PALMITAMIDOPROPYLTRIMONIUM CHLORIDE(UNII: N2U96D202F)
ADENOSINE(UNII: K72T3FS567)
TOCOPHEROL(UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TALC(UNII: 7SEV7J4R1U)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
DIGLYCERIN(UNII: 3YC120743U)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PEG/PPG-19/19 DIMETHICONE(UNII: EHH90CO7TL)
GRAPEFRUIT PEEL(UNII: 3582N05Q44)
ARGAN OIL(UNII: 4V59G5UW9X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-107-021 in 1 CARTON 14/01/2016
150 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 01/14/2016

PRINCIPAL DISPLAY PANEL

BCDation All Master Box