NDC Code(s) : 59078-127-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Timeless GF-Factor EmulsionGlycerin EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-127
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1344 mg in 140 mL
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN17626 mg in 140 mL
Inactive Ingredients
Ingredient Name Strength
CROTON LECHLERI RESIN(UNII: GGG6W25C63)
STEARIC ACID(UNII: 4ELV7Z65AP)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
XANTHAN GUM(UNII: TTV12P4NEE)
GLYCINE(UNII: TE7660XO1C)
MADECASSOSIDE(UNII: CQ2F5O6YIY)
SORBITOL(UNII: 506T60A25R)
ASPARTIC ACID(UNII: 30KYC7MIAI)
TYROSINE(UNII: 42HK56048U)
VALINE(UNII: HG18B9YRS7)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ALLANTOIN(UNII: 344S277G0Z)
C12-13 PARETH-3(UNII: DMC6N3419L)
C12-13 PARETH-23(UNII: J1WW1510L4)
XYLITYLGLUCOSIDE(UNII: O0IEZ166FB)
ANHYDROXYLITOL(UNII: 8XWR7NN42F)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
SERINE(UNII: 452VLY9402)
GLUTAMIC ACID(UNII: 3KX376GY7L)
LACTIC ACID(UNII: 33X04XA5AT)
SODIUM LACTATE(UNII: TU7HW0W0QT)
LYSINE(UNII: K3Z4F929H6)
PROLINE(UNII: 9DLQ4CIU6V)
ISOLEUCINE(UNII: 04Y7590D77)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
HISTIDINE(UNII: 4QD397987E)
METHIONINE(UNII: AE28F7PNPL)
CYSTEINE(UNII: K848JZ4886)
PROPANEDIOL(UNII: 5965N8W85T)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
ADENOSINE(UNII: K72T3FS567)
THREONINE(UNII: 2ZD004190S)
PHENYLALANINE(UNII: 47E5O17Y3R)
POLYSORBATE 60(UNII: CAL22UVI4M)
WATER(UNII: 059QF0KO0R)
NIACINAMIDE(UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
TROMETHAMINE(UNII: 023C2WHX2V)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
METHYLPROPANEDIOL(UNII: N8F53B3R4R)
XYLITOL(UNII: VCQ006KQ1E)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
PEG-100 STEARATE(UNII: YD01N1999R)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALANINE(UNII: OF5P57N2ZX)
ARGININE(UNII: 94ZLA3W45F)
LEUCINE(UNII: GMW67QNF9C)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
DI-C12-13 ALKYL MALATE(UNII: RRL7C51WPD)
LAURETH-7(UNII: Z95S6G8201)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-127-011 in 1 CARTON 19/01/2016
1140 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

Emulsion