NDC Code 13733-401-01 | pharmacompass.com

NDC Code(s) : 13733-401-01, 13733-402-01
Packager : Able C&C Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 70MLOctinoxate, Octocrylene, Octisalate, Avobenzone LOTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:13733-401
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.9 g in 70 g
OCTOCRYLENE(UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.5 g in 70 g
OCTISALATE(UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3.15 g in 70 g
AVOBENZONE(UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.8 g in 70 g

Ingredient Name	Strength
Inactive Ingredients
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
HELICHRYSUM ARENARIUM FLOWER(UNII: GN27F71368)
METHYL METHACRYLATE(UNII: 196OC77688)
BEMOTRIZINOL(UNII: PWZ1720CBH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALCEA ROSEA ROOT(UNII: 7PBQ0GP92D)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERIN(UNII: PDC6A3C0OX)
NYLON-12(UNII: 446U8J075B)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PORTULACA OLERACEA SEED(UNII: M08917G08Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DENDRANTHEMA INDICUM FLOWER(UNII: I6OER6U04L)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PRUNUS MUME FLOWER(UNII: 2N8872050J)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
SAGE OIL(UNII: U27K0H1H2O)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
WHITE MULBERRY(UNII: MN25R0HH5A)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
CHINESE CINNAMON(UNII: WS4CQ062KM)
ARTEMISIA PRINCEPS LEAF(UNII: SY077EW02G)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
DIMETHICONE(UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
BETAINE(UNII: 3SCV180C9W)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CAMELLIA JAPONICA FLOWER(UNII: KUB8101TNF)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-401-01	70 g in 1 CARTON Type 0: Not a Combination Product	18/06/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/18/2018

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK 40MLOctinoxate, Octocrylene, Octisalate, Avobenzone LOTION

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:13733-402
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE(UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.8 g in 40 g
OCTOCRYLENE(UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 40 g
OCTISALATE(UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.8 g in 40 g
AVOBENZONE(UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.6 g in 40 g

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
HELICHRYSUM ARENARIUM FLOWER(UNII: GN27F71368)
METHYL METHACRYLATE(UNII: 196OC77688)
BEMOTRIZINOL(UNII: PWZ1720CBH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
ALCEA ROSEA ROOT(UNII: 7PBQ0GP92D)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERIN(UNII: PDC6A3C0OX)
NYLON-12(UNII: 446U8J075B)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CINCHONA PUBESCENS BARK(UNII: S96N10R972)
WATER(UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
NELUMBO NUCIFERA FLOWER(UNII: 61W322NLDV)
PORTULACA OLERACEA SEED(UNII: M08917G08Z)
DIMETHICONE(UNII: 92RU3N3Y1O)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
ROSA DAVURICA FLOWER BUD(UNII: XR42W0H5IU)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
DENDRANTHEMA INDICUM FLOWER(UNII: I6OER6U04L)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
PSIDIUM GUAJAVA LEAF(UNII: PM0F263X0Y)
ABRONIA VILLOSA LEAF(UNII: A138B5260A)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
PRUNUS MUME FLOWER(UNII: 2N8872050J)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
SAGE OIL(UNII: U27K0H1H2O)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
PELARGONIUM GRAVEOLENS FLOWER OIL(UNII: 3K0J1S7QGC)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
WHITE MULBERRY(UNII: MN25R0HH5A)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
PUERARIA MONTANA VAR. LOBATA ROOT(UNII: PET93F4I3C)
CHINESE CINNAMON(UNII: WS4CQ062KM)
CAMELLIA JAPONICA FLOWER(UNII: KUB8101TNF)
ARTEMISIA PRINCEPS LEAF(UNII: SY077EW02G)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
BETAINE(UNII: 3SCV180C9W)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13733-402-01	40 g in 1 CARTON Type 0: Not a Combination Product	18/06/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/18/2018

NDC 13733-401-01
API & Excipient Details

marketed by Able C&C Co., Ltd. under NDC Code 13733-401-01

NDC Code(s) : 13733-401-01, 13733-402-01
Packager : Able C&C Co., Ltd.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 13733-401-01 API & Excipient Details

marketed by Able C&C Co., Ltd. under NDC Code 13733-401-01

NDC Code(s) : 13733-401-01, 13733-402-01Packager : Able C&C Co., Ltd.

INGREDIENTS AND APPEARANCE

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 13733-401-01
API & Excipient Details

NDC Code(s) : 13733-401-01, 13733-402-01
Packager : Able C&C Co., Ltd.