NDC Code(s) : 43419-340-19
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

IOPE B.B BBOCTINOXATE and TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-340
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2 g in 40 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.996 g in 40 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
METHYL TRIMETHICONE(UNII: S73ZQI0GXM)
ALCOHOL(UNII: 3K9958V90M)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ARBUTIN(UNII: C5INA23HXF)
SQUALANE(UNII: GW89575KF9)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
PEG/PPG-19/19 DIMETHICONE(UNII: EHH90CO7TL)
CALCIUM STEARATE(UNII: 776XM7047L)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
STEARIC ACID(UNII: 4ELV7Z65AP)
JUJUBE FRUIT(UNII: G55HNL2C70)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
YEAST MANNAN(UNII: 91R887N59P)
OLEANOLIC ACID(UNII: 6SMK8R7TGJ)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
XANTHAN GUM(UNII: TTV12P4NEE)
MADECASSOSIDE(UNII: CQ2F5O6YIY)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
TOCOPHEROL(UNII: R0ZB2556P8)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
TEA TREE OIL(UNII: VIF565UC2G)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-340-191 in 1 CARTON 19/09/2012
140 mL 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 NOT FINAL part352 09/19/2012

PRINCIPAL DISPLAY PANEL

IOPE

IOPE

B•B

BB CREAM
SUNSCREEN
BROAD SPECTRUM
SPF 20

40 ml / 1.35 fl. oz.

Principal Display Panel - 40 ml Tube Carton