NDC Code(s) : 43419-701-07, 43419-702-07, 43419-703-07
Packager : AMOREPACIFIC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LANEIGE LIP TREATMENT OCTINOXATE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.12 g in 4 g
Inactive Ingredients
Ingredient Name Strength
SQUALANE(UNII: GW89575KF9)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
MICA(UNII: V8A1AW0880)
SHEA BUTTER(UNII: K49155WL9Y)
CANDELILLA WAX(UNII: WL0328HX19)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
CARNAUBA WAX(UNII: R12CBM0EIZ)
YELLOW WAX(UNII: 2ZA36H0S2V)
CERESIN(UNII: Q1LS2UJO3A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
PERSIC OIL(UNII: 5M26W7T072)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
D&C RED NO. 6(UNII: 481744AI4O)
PLUM SEED OIL(UNII: 67EIU8N086)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ADENOSINE(UNII: K72T3FS567)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
AGAR(UNII: 89T13OHQ2B)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ISOSTEARIC ACID(UNII: X33R8U0062)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C RED NO. 7(UNII: ECW0LZ41X8)
Aluminum Oxide(UNII: LMI26O6933)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-701-074 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2011
LANEIGE LIP TREATMENT OCTINOXATE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-702
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.12 g in 4 g
Inactive Ingredients
Ingredient Name Strength
SQUALANE(UNII: GW89575KF9)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
MICA(UNII: V8A1AW0880)
SHEA BUTTER(UNII: K49155WL9Y)
CANDELILLA WAX(UNII: WL0328HX19)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
CARNAUBA WAX(UNII: R12CBM0EIZ)
YELLOW WAX(UNII: 2ZA36H0S2V)
CERESIN(UNII: Q1LS2UJO3A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
PERSIC OIL(UNII: 5M26W7T072)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
D&C RED NO. 6(UNII: 481744AI4O)
PLUM SEED OIL(UNII: 67EIU8N086)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ADENOSINE(UNII: K72T3FS567)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
AGAR(UNII: 89T13OHQ2B)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ISOSTEARIC ACID(UNII: X33R8U0062)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Aluminum Oxide(UNII: LMI26O6933)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-702-074 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2011
LANEIGE LIP TREATMENT OCTINOXATE STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43419-703
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE0.12 g in 4 g
Inactive Ingredients
Ingredient Name Strength
SQUALANE(UNII: GW89575KF9)
ASTROCARYUM MURUMURU SEED BUTTER(UNII: 12V64UPU6R)
MICA(UNII: V8A1AW0880)
SHEA BUTTER(UNII: K49155WL9Y)
CANDELILLA WAX(UNII: WL0328HX19)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
GLYCERIN(UNII: PDC6A3C0OX)
SUNFLOWER OIL(UNII: 3W1JG795YI)
CARNAUBA WAX(UNII: R12CBM0EIZ)
YELLOW WAX(UNII: 2ZA36H0S2V)
CERESIN(UNII: Q1LS2UJO3A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
APRICOT KERNEL OIL(UNII: 54JB35T06A)
PERSIC OIL(UNII: 5M26W7T072)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
D&C RED NO. 6(UNII: 481744AI4O)
PLUM SEED OIL(UNII: 67EIU8N086)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ADENOSINE(UNII: K72T3FS567)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
AGAR(UNII: 89T13OHQ2B)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
ISOSTEARIC ACID(UNII: X33R8U0062)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
D&C RED NO. 28(UNII: 767IP0Y5NH)
Aluminum Oxide(UNII: LMI26O6933)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43419-703-074 g in 1 CYLINDER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/01/2011

PRINCIPAL DISPLAY PANEL

LANEIGE

LIP TREATMENT
SPF 17

Principal Display Panel - 4 g Carton (#1)

PRINCIPAL DISPLAY PANEL

LANEIGE

LIP TREATMENT
SPF 17

Principal Display Panel - 4 g Carton (#2)

PRINCIPAL DISPLAY PANEL

LANEIGE

LIP TREATMENT
SPF 17

Principal Display Panel - 4 g Carton (#3)