NDC Code(s) : 59078-128-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Timeless GF-Factor CreamGlycerin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-128
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1440 mg in 50 mL
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN5067.475 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
NIACINAMIDE(UNII: 25X51I8RD4)
GLYCINE(UNII: TE7660XO1C)
MADECASSOSIDE(UNII: CQ2F5O6YIY)
GLUTAMIC ACID(UNII: 3KX376GY7L)
NEOPENTYL GLYCOL DICAPRATE(UNII: 77T908SE82)
BETAINE(UNII: 3SCV180C9W)
PENTAERYTHRITYL TETRAETHYLHEXANOATE(UNII: XJ7052W897)
PHYTOSTERYL ISOSTEARYL DIMER DILINOLEATE(UNII: MRH313IE85)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
STEARIC ACID(UNII: 4ELV7Z65AP)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
ALCOHOL(UNII: 3K9958V90M)
MICA(UNII: V8A1AW0880)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SORBITOL(UNII: 506T60A25R)
ASPARTIC ACID(UNII: 30KYC7MIAI)
LEUCINE(UNII: GMW67QNF9C)
ARGININE(UNII: 94ZLA3W45F)
PHENYLALANINE(UNII: 47E5O17Y3R)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
ALANINE(UNII: OF5P57N2ZX)
TYROSINE(UNII: 42HK56048U)
VALINE(UNII: HG18B9YRS7)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
LYSINE(UNII: K3Z4F929H6)
PANTHENOL(UNII: WV9CM0O67Z)
WATER(UNII: 059QF0KO0R)
MANGIFERA INDICA SEED(UNII: EDO6T18WTC)
ASCORBYL TETRAISOPALMITATE(UNII: 47143LT58A)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
SERINE(UNII: 452VLY9402)
LACTIC ACID(UNII: 33X04XA5AT)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-128-011 in 1 CARTON 19/01/2016
150 mL 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 not final part356 01/14/2016

PRINCIPAL DISPLAY PANEL

Cream