NDC Code(s) : 43419-320-16, 43419-321-17, 43419-322-18, 43419-323-19, 43419-324-20, 43419-325-21, 43419-326-22, 43419-327-23
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:43419-320
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-320-161 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-321
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-321-171 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-322
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-322-181 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-323
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-323-191 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-324
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-324-201 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-325
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-325-211 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-326
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-326-221 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010
AMOREPACIFIC OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-327
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.05 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.0098 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.1014 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE(UNII: 92RU3N3Y1O)
BAMBUSA VULGARIS SAP(UNII: 26W4035XBO)
ASIAN GINSENG(UNII: CUQ3A77YXI)
ALCOHOL(UNII: 3K9958V90M)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SUNFLOWER OIL(UNII: 3W1JG795YI)
BETAINE(UNII: 3SCV180C9W)
GINGER(UNII: C5529G5JPQ)
CAFFEINE(UNII: 3G6A5W338E)
THEANINE(UNII: 8021PR16QO)
HYALURONIC ACID(UNII: S270N0TRQY)
MAGNESIUM ASPARTATE(UNII: R17X820ROL)
ZINC GLUCONATE(UNII: U6WSN5SQ1Z)
SORBITOL(UNII: 506T60A25R)
SERINE(UNII: 452VLY9402)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GLUTAMIC ACID(UNII: 3KX376GY7L)
COPPER GLUCONATE(UNII: RV823G6G67)
CALCIUM GLUCONATE(UNII: SQE6VB453K)
ALANINE(UNII: OF5P57N2ZX)
LYSINE(UNII: K3Z4F929H6)
ARGININE(UNII: 94ZLA3W45F)
THREONINE(UNII: 2ZD004190S)
TREHALOSE(UNII: B8WCK70T7I)
PROLINE(UNII: 9DLQ4CIU6V)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-327-231 in 1 CARTON
130 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/15/2010

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