NDC Code(s) : 70319-005-01, 70319-005-02
Packager : COSRX inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aloe Soothing SuncreamOCTINOXATE,TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70319-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.6 mg in 50 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE0.74 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
BEMOTRIZINOL(UNII: PWZ1720CBH)
ENSULIZOLE(UNII: 9YQ9DI1W42)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
AMILOXATE(UNII: 376KTP06K8)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
ALCOHOL(UNII: 3K9958V90M)
DIMETHICONE(UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
C14-22 ALCOHOLS(UNII: B1K89384RJ)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
ALOE ARBORESCENS LEAF(UNII: 09TD8L5SQV)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PEG-100 STEARATE(UNII: YD01N1999R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
C12-20 ALKYL GLUCOSIDE(UNII: K67N5Z1RUA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
XANTHAN GUM(UNII: TTV12P4NEE)
TROLAMINE(UNII: 9O3K93S3TK)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:70319-005-021 in 1 PACKAGE 18/12/2017
1NDC:70319-005-0150 mL in 1 CONTAINER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/18/2017

PRINCIPAL DISPLAY PANEL

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