NDC Code(s) : 43419-714-59, 43419-715-60
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sulwhasoo Lumitouch Multi-Base Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-714
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate2.1 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.65 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.94 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DIMETHICONE(UNII: 92RU3N3Y1O)
MICA(UNII: V8A1AW0880)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PUMPKIN(UNII: SYW0QUB89Y)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALCOHOL(UNII: 3K9958V90M)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE(UNII: KH3E3096OO)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
LILIUM TIGRINUM(UNII: 47Z05W73EZ)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
HONEY(UNII: Y9H1V576FH)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
BARIUM SULFATE(UNII: 25BB7EKE2E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-714-5930 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 11/01/2010
Sulwhasoo Lumitouch Multi-Base Octinoxate, TITANIUM DIOXIDE, and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-715
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate2.1 mL in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.65 mL in 30 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE2.94 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CETYL ETHYLHEXANOATE(UNII: 134647WMX4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERIN(UNII: PDC6A3C0OX)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DIMETHICONE(UNII: 92RU3N3Y1O)
MICA(UNII: V8A1AW0880)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PUMPKIN(UNII: SYW0QUB89Y)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ALCOHOL(UNII: 3K9958V90M)
CHRYSANTHEMUM X MORIFOLIUM FLOWER(UNII: 2GR3C1A0WV)
TANGERINE(UNII: KH3E3096OO)
NELUMBO NUCIFERA SEED(UNII: YCT65RT6AE)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
LILIUM TIGRINUM(UNII: 47Z05W73EZ)
REHMANNIA GLUTINOSA ROOT(UNII: 1BEM3U6LQQ)
ADENOPHORA STRICTA ROOT(UNII: C768H06N7E)
HONEY(UNII: Y9H1V576FH)
LIGUSTICUM TENUISSIMUM ROOT(UNII: 2O0H84E074)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GARDENIA JASMINOIDES FRUIT(UNII: 7CTH8MD549)
PAPRIKA(UNII: X72Z47861V)
ANGELICA ACUTILOBA ROOT(UNII: 3W51R3EK30)
TRICHOSANTHES KIRILOWII ROOT(UNII: V409XGE0TS)
BARIUM SULFATE(UNII: 25BB7EKE2E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-715-6030 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 11/01/2010

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH MULTI-BASE

Principal Display Panel - 30 ML Carton

PRINCIPAL DISPLAY PANEL

Sulwhasoo

LUMITOUCH MULTI-BASE

Principal Display Panel - 30 ML Carton