NDC Code(s) : 59078-140-01
Packager : Tonymoly Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TONYMOLY Fitting Foundation 23 SPF30 Natural BeigeTitanium Dioxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59078-140
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN(UNII: PDC6A3C0OX)
(GLYCERIN - UNII:PDC6A3C0OX) 		GLYCERIN881.3 mg in 35 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE13990.725 mg in 35 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1963.5 g in 35 mL
DIMETHICONE(UNII: 92RU3N3Y1O)
(DIMETHICONE - UNII:92RU3N3Y1O) 		DIMETHICONE1963.5 mg in 35 mL
Inactive Ingredients
Ingredient Name Strength
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
NIACINAMIDE(UNII: 25X51I8RD4)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
MAGNESIUM SULFATE(UNII: DE08037SAB)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM(UNII: 7FLD91C86K)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
STEARIC ACID(UNII: 4ELV7Z65AP)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
MICA(UNII: V8A1AW0880)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
HAMAMELIS VIRGINIANA FLOWER WATER(UNII: 222MYC9QUV)
WATER(UNII: 059QF0KO0R)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
CERAMIDE 3(UNII: 4370DF050B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:59078-140-011 in 1 CARTON 19/01/2016
135 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 part352 01/14/2016

PRINCIPAL DISPLAY PANEL

Product