NDC Code(s) : 59078-135-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Timeless Carat Foun Cover 01 Skin BeigeTitanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-135
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 DIOXIDE2.33225 g in 9.5 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.7448 g in 9.5 g
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE0.304 g in 9.5 g
Inactive Ingredients
Ingredient Name Strength
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
DIMER DILINOLEYL DIMER DILINOLEATE(UNII: 0E2D5DBT7M)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
ALUMINUM OXIDE(UNII: LMI26O6933)
LICORICE(UNII: 61ZBX54883)
ADENOSINE(UNII: K72T3FS567)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
C30-45 ALKYL METHICONE(UNII: NFX970DSI2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
RAFFINOSE(UNII: N5O3QU595M)
WATER(UNII: 059QF0KO0R)
DIAZOLIDINYL UREA(UNII: H5RIZ3MPW4)
ACETYL TETRAPEPTIDE-9(UNII: VMO8OOD3V0)
GOLD(UNII: 79Y1949PYO)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
STANNIC OXIDE(UNII: KM7N50LOS6)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
OCTYLDODECANOL(UNII: 461N1O614Y)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-135-011 in 1 CARTON 19/01/2016
19.5 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

Product