NDC Code(s) : 43419-002-04, 43419-002-13, 43419-003-04, 43419-003-13, 43419-007-04, 43419-007-13
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulwhasoo OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.9 g in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.498 g in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.588 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CALCIUM STEARATE(UNII: 776XM7047L)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
CERAMIDE 3(UNII: 4370DF050B)
NIACINAMIDE(UNII: 25X51I8RD4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIOSCOREA JAPONICA ROOT(UNII: I43FCF3356)
BARIUM SULFATE(UNII: 25BB7EKE2E)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PERSICARIA TINCTORIA LEAF(UNII: FU6582QMPV)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE PEEL(UNII: JU3D414057)
CORNUS OFFICINALIS FRUIT(UNII: 23NL8NQ187)
HYALURONIC ACID(UNII: S270N0TRQY)
POLYGONATUM ODORATUM ROOT(UNII: KPF03O64AZ)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
LILIUM LANCIFOLIUM FLOWERING TOP(UNII: X67Z2963PI)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED(UNII: 8DW238I7ZI)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
HONEY(UNII: Y9H1V576FH)
LYCIUM CHINENSE ROOT BARK(UNII: 2Q9D9P290N)
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
GLYCERIN(UNII: PDC6A3C0OX)
NELUMBO NUCIFERA LEAF(UNII: 60C608DPVT)
TERMINALIA CHEBULA FRUIT(UNII: S8R4V700NK)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-002-0430 mL in 1 JAR
2NDC:43419-002-134 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/01/2011
Sulwhasoo OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-003
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.9 g in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.498 g in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.588 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CALCIUM STEARATE(UNII: 776XM7047L)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
CERAMIDE 3(UNII: 4370DF050B)
NIACINAMIDE(UNII: 25X51I8RD4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIOSCOREA JAPONICA ROOT(UNII: I43FCF3356)
BARIUM SULFATE(UNII: 25BB7EKE2E)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PERSICARIA TINCTORIA LEAF(UNII: FU6582QMPV)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE PEEL(UNII: JU3D414057)
CORNUS OFFICINALIS FRUIT(UNII: 23NL8NQ187)
HYALURONIC ACID(UNII: S270N0TRQY)
POLYGONATUM ODORATUM ROOT(UNII: KPF03O64AZ)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
LILIUM LANCIFOLIUM FLOWERING TOP(UNII: X67Z2963PI)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED(UNII: 8DW238I7ZI)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
HONEY(UNII: Y9H1V576FH)
LYCIUM CHINENSE ROOT BARK(UNII: 2Q9D9P290N)
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
GLYCERIN(UNII: PDC6A3C0OX)
NELUMBO NUCIFERA LEAF(UNII: 60C608DPVT)
TERMINALIA CHEBULA FRUIT(UNII: S8R4V700NK)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-003-0430 mL in 1 JAR
2NDC:43419-003-134 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/01/2011
Sulwhasoo OCTINOXATE, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.9 g in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.498 g in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE0.588 g in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE(UNII: 92RU3N3Y1O)
SQUALANE(UNII: GW89575KF9)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
FERRIC OXIDE RED(UNII: 1K09F3G675)
CALCIUM STEARATE(UNII: 776XM7047L)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ADENOSINE(UNII: K72T3FS567)
CERAMIDE 3(UNII: 4370DF050B)
NIACINAMIDE(UNII: 25X51I8RD4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIOSCOREA JAPONICA ROOT(UNII: I43FCF3356)
BARIUM SULFATE(UNII: 25BB7EKE2E)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
PERSICARIA TINCTORIA LEAF(UNII: FU6582QMPV)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE PEEL(UNII: JU3D414057)
CORNUS OFFICINALIS FRUIT(UNII: 23NL8NQ187)
HYALURONIC ACID(UNII: S270N0TRQY)
POLYGONATUM ODORATUM ROOT(UNII: KPF03O64AZ)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
LILIUM LANCIFOLIUM FLOWERING TOP(UNII: X67Z2963PI)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED(UNII: 8DW238I7ZI)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
HONEY(UNII: Y9H1V576FH)
LYCIUM CHINENSE ROOT BARK(UNII: 2Q9D9P290N)
PAEONIA SUFFRUTICOSA ROOT(UNII: 7M7E9A2C8J)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
MAGNESIUM MYRISTATE(UNII: Z1917F0578)
GLYCERIN(UNII: PDC6A3C0OX)
NELUMBO NUCIFERA LEAF(UNII: 60C608DPVT)
TERMINALIA CHEBULA FRUIT(UNII: S8R4V700NK)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-007-0430 mL in 1 JAR
2NDC:43419-007-134 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 10/15/2011

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Principal Display Panel - 30 ml Jar Carton No. 21

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Principal Display Panel - 30 ml Jar Carton No. 23

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH FOUNDATION (CREAM)

Principal Display Panel - 30 ml Jar Carton No. 25