NDC Code(s) : 31645-182-01, 31645-182-02
Packager : Physicians Formula Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Super BB All in One Beauty Balm StickTitanium Dioxide, Zinc Oxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-182
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 DIOXIDE5.76 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.96 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ISOCETYL STEARATE(UNII: 3RJ7186O9W)
CANDELILLA WAX(UNII: WL0328HX19)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
CARNAUBA WAX(UNII: R12CBM0EIZ)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
SHEA BUTTER(UNII: K49155WL9Y)
CALCIUM ALUMINUM BOROSILICATE(UNII: 3JRB8A35M0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ARACHIDYL ALCOHOL(UNII: 1QR1QRA9BU)
GLYCERIN(UNII: PDC6A3C0OX)
PALMITIC ACID(UNII: 2V16EO95H1)
STEARIC ACID(UNII: 4ELV7Z65AP)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-182-021 in 1 CARTON 01/01/2015
1NDC:31645-182-016.8 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 final part352 01/01/2015

PRINCIPAL DISPLAY PANEL

PDP