NDC Code(s) : 43419-505-02, 43419-505-11, 43419-506-02, 43419-506-11, 43419-507-02, 43419-507-11, 43419-508-02, 43419-508-11, 43419-509-02, 43419-509-11, 43419-510-02, 43419-510-11
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION 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 PRESCRIPTION DRUG Item Code (Source) NDC:43419-505
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-505-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-505-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-506
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-506-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-506-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-507
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-507-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-507-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-508
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-508-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-508-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-509
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-509-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-509-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-510
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.5 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.245 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.294 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHYLLOSTACHYS RETICULATA RESIN(UNII: KX390ME4SP)
ASIAN GINSENG(UNII: CUQ3A77YXI)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
EDETATE DISODIUM(UNII: 7FLD91C86K)
CAMELLIA JAPONICA SEED OIL(UNII: U37N0S910T)
WATER(UNII: 059QF0KO0R)
GINGER(UNII: C5529G5JPQ)
SUNFLOWER OIL(UNII: 3W1JG795YI)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
POMEGRANATE(UNII: 56687D1Z4D)
CAFFEINE(UNII: 3G6A5W338E)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
TOCOPHERSOLAN(UNII: O03S90U1F2)
POLOXAMER 338(UNII: F75JV2T505)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
CAMELLIA SINENSIS FLOWER(UNII: 9I2BJY2J17)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
TREHALOSE(UNII: B8WCK70T7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-510-0230 mL in 1 BOTTLE, PUMP
2NDC:43419-510-111 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 06/01/2011

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