NDC Code(s) : 31645-194-01, 31645-194-02
Packager : Physicians Formula, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Argan Wear Ultra-Nourishing Argan Oil BB ConcealerTitanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-194
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.96 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE5.76 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ARGANIA SPINOSA SEED(UNII: 8H7X7XB54H)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)(UNII: Z570VEV8XK)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
WATER(UNII: 059QF0KO0R)
DIMETHICONE 100(UNII: RO266O364U)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
MICA(UNII: V8A1AW0880)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
CALCIUM ALUMINUM BOROSILICATE(UNII: 3JRB8A35M0)
SALIX ALBA BARK(UNII: 205MXS71H7)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-194-021 in 1 CARTON 01/01/2016
1NDC:31645-194-0110 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2016

PRINCIPAL DISPLAY PANEL

PDP