NDC Code(s) : 59078-111-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Timeless Carat Moisture Soft Powder Pact 21 Skin BeigeTitanium Dioxide POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-111
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 DIOXIDE1.267 g in 14 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.5488 g in 14 g
Inactive Ingredients
Ingredient Name Strength
SACCHAROMYCES LYSATE(UNII: R85W246Z1C)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
MICA(UNII: V8A1AW0880)
BORON NITRIDE(UNII: 2U4T60A6YD)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
STEARIC ACID(UNII: 4ELV7Z65AP)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA(UNII: 1211AIM8G7)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GOLD(UNII: 79Y1949PYO)
WATER(UNII: 059QF0KO0R)
NYLON-12(UNII: 446U8J075B)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
TALC(UNII: 7SEV7J4R1U)
OCTINOXATE(UNII: 4Y5P7MUD51)
ALUMINUM OXIDE(UNII: LMI26O6933)
DIMETHICONE(UNII: 92RU3N3Y1O)
PEARL (HYRIOPSIS CUMINGII)(UNII: A75L5FZ40U)
BOSCALID(UNII: 32MS8ZRD1V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-111-011 in 1 CARTON 19/01/2016
114 g 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 01/14/2016

PRINCIPAL DISPLAY PANEL

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