NDC Code(s) : 13733-214-01
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 Fresh Sun SPF50Octinoxate, Octocrylene, Octisalate, Avobenzone STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-214
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE5 mg in 1 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.5 mg in 1 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 mg in 1 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN(UNII: I9O0E3H2ZE)
CANDELILLA WAX(UNII: WL0328HX19)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
STEARALKONIUM HECTORITE(UNII: OLX698AH5P)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
OCTYLDODECANOL(UNII: 461N1O614Y)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CERESIN(UNII: Q1LS2UJO3A)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
BEMOTRIZINOL(UNII: PWZ1720CBH)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
YELLOW WAX(UNII: 2ZA36H0S2V)
LEMON OIL(UNII: I9GRO824LL)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
HAMAMELIS VIRGINIANA LEAF(UNII: T07U1161SV)
MENTHA X ROTUNDIFOLIA LEAF(UNII: K59TXG2L3U)
SPEARMINT(UNII: J7I2T6IV1N)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALCOHOL(UNII: 3K9958V90M)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
MENTHA PIPERITA LEAF(UNII: A389O33LX6)
TALC(UNII: 7SEV7J4R1U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-214-0111 g in 1 CONTAINER Type 0: Not a Combination Product08/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2016

PRINCIPAL DISPLAY PANEL

AllAroundSafeBlockFreshSunStick