NDC Code(s) : 43419-803-17, 43419-804-17
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MAMONDE PACT BLOOMING 21OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-803
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.384 g in 12 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.51216 g in 12 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.2352 g in 12 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
NYLON-12(UNII: 446U8J075B)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
STANNIC OXIDE(UNII: KM7N50LOS6)
ROSA CENTIFOLIA FLOWER(UNII: CS4TE8FF7O)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-803-171 in 1 CARTON
112 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/30/2013
MAMONDE PACT BLOOMING 23OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.384 g in 12 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.51216 g in 12 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.2352 g in 12 g
Inactive Ingredients
Ingredient Name Strength
TALC(UNII: 7SEV7J4R1U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
NYLON-12(UNII: 446U8J075B)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
DIMETHICONE(UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
STANNIC OXIDE(UNII: KM7N50LOS6)
ROSA CENTIFOLIA FLOWER(UNII: CS4TE8FF7O)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-804-171 in 1 CARTON
112 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/30/2013

PRINCIPAL DISPLAY PANEL

Mamonde

POWDER PACT

blooming

ROSA CENTIFOLIA FLOWER EXTRACT
NOVEL PETAL POWDER

SPF25
Sunscreen
Net wt. 12 g / 0.42 oz.

Principal Display Panel - 12 g Container Carton - 21

PRINCIPAL DISPLAY PANEL

Mamonde

POWDER PACT

blooming

ROSA CENTIFOLIA FLOWER EXTRACT
NOVEL PETAL POWDER

SPF25
Sunscreen
Net wt. 12 g / 0.42 oz.

Principal Display Panel - 12 g Container Carton - 23