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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4.9 g in 70 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE3.5 g in 70 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE3.15 g in 70 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2.8 g in 70 g
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-401-0170 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
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
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.8 g in 40 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 40 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE1.8 g in 40 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE1.6 g in 40 g
Inactive Ingredients
Ingredient Name Strength
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-402-0140 g in 1 CARTON Type 0: Not a Combination Product18/06/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 06/18/2018

PRINCIPAL DISPLAY PANEL

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 _ 70ML (1)

PRINCIPAL DISPLAY PANEL

MISSHA ALL AROUND SAFE BLOCK ESSENCE SUN MILK SPF50 _ 40ML (1)