NDC Code(s) : 43419-512-21, 43419-514-21, 43419-511-21, 43419-513-21
Packager : AMOREPACIFIC CORPORATION

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-512
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TOCOPHEROL(UNII: R0ZB2556P8)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
TRIMETHYLSILOXYSILICATE (M/Q 0.66)(UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-512-212 in 1 CARTON 12/05/2012
115 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 Drug M020 12/05/2012
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-514
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TOCOPHEROL(UNII: R0ZB2556P8)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
TRIMETHYLSILOXYSILICATE (M/Q 0.66)(UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-514-212 in 1 CARTON 12/05/2012
115 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 Drug M020 12/05/2012
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-511
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TOCOPHEROL(UNII: R0ZB2556P8)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
TRIMETHYLSILOXYSILICATE (M/Q 0.66)(UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-511-212 in 1 CARTON 12/05/2012
115 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 Drug M020 12/05/2012
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43419-513
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.05 g in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.6225 g in 15 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE1.47 g in 15 g
Inactive Ingredients
Ingredient Name Strength
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
TOCOPHEROL(UNII: R0ZB2556P8)
POLYGLYCERYL-3 RICINOLEATE(UNII: MZQ63P0N0W)
TRIMETHYLSILOXYSILICATE (M/Q 0.66)(UNII: 5041RX63GN)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
PEG-10 DIMETHICONE (600 CST)(UNII: 8PR7V1SVM0)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE(UNII: 75D21FL1PI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
ISOSTEARIC ACID(UNII: X33R8U0062)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
DIMETHICONE(UNII: 92RU3N3Y1O)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
WATER(UNII: 059QF0KO0R)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-513-212 in 1 CARTON 12/05/2012
115 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 Drug M020 12/05/2012

LABELER - AMOREPACIFIC CORPORATION(631035289)

PRINCIPAL DISPLAY PANEL

Amore Pacific

Color Control Cushion Compact

Broad Spectrum SPF 50+

Sunscreen

Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

104

PRINCIPAL DISPLAY PANEL

AMORE PACIFIC

COLOR CONTROL CUSHION COMPACT

Broad Spectrum SPF 50+
Sunscreen

Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

106

PRINCIPAL DISPLAY PANEL

AMORE PACIFIC

COLOR CONTROL CUSHION COMPACT

Broad Spectrum SPF 50+
Sunscreen

Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

204

PRINCIPAL DISPLAY PANEL

AMOREPACIFIC

COLOR CONTROL CUSHION COMPACT

Broad Spectrum SPF 50+

Sunscreen

Net wt. 1.05 oz. (0.52 oz. x 2) / 30g (15g X 2)

208