NDC Code(s) : 13733-213-01
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 Mild Sun SPF30Zinc Oxide, Titanium dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13733-213
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.8 mg in 1 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE4.15 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
COCO GLUCOSIDE(UNII: ICS790225B)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
C20-22 ALKYL PHOSPHATE(UNII: L4VKP0Y7RP)
SQUALANE(UNII: GW89575KF9)
C20-22 ALCOHOLS(UNII: O4M0347C6A)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
POLYSORBATE 60(UNII: CAL22UVI4M)
HYDROGEN DIMETHICONE (13 CST)(UNII: 4QGR4P2YOI)
XANTHAN GUM(UNII: TTV12P4NEE)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13733-213-0150 g in 1 TUBE 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

SafeBlockMildSun30