NDC Code(s) : 76209-234-01
Packager : Market America

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

De-Aging Moisturizing Day Creme With Sunscreen SPF 20OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76209-234
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W)
OCTISALATE30 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y)
OXYBENZONE30 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP)
TITANIUM DIOXIDE4 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARIC ACID(UNII: 4ELV7Z65AP)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CERAMIDE 2(UNII: C04977SRJ5)
JUJUBE FRUIT(UNII: G55HNL2C70)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
ALUMINUM OXIDE(UNII: LMI26O6933)
PANTHENOL(UNII: WV9CM0O67Z)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
TROLAMINE(UNII: 9O3K93S3TK)
SODIUM PHOSPHATE(UNII: SE337SVY37)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
EDETIC ACID(UNII: 9G34HU7RV0)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76209-234-0160 mL in 1 BOTTLE Type 0: Not a Combination Product19/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 06/08/2011

LABELER - Market America(797412236)

PRINCIPAL DISPLAY PANEL

ceLLuLaR laboratories  net vol. 2 fl. oz./60 mL

PRINCIPAL DISPLAY PANEL

Manufactured for and exclusively distributed in the U.S. by: Market America, Inc. 1302 Pleasant Ridge Road Greensboro, NC 27409  Imported and exclusively distributed by: Market Hong Kong, Inc., in Hong Kong  Unit 1615-1620, Level 16, Tower II Grend Century Place 193 Prince Edward Road West Mongkok, Kowloon, Hong Kong.  Market America, Inc., in Canada 100 Wilkinson Road, Unit 5-6 Brampton, Ontario L6T 4Y9.  Market Australia, Inc., in Australia Unit 2/36 Liverpool St. Ingleburn, NSW 2565

PRINCIPAL DISPLAY PANEL

Drug Facts

PRINCIPAL DISPLAY PANEL

Drug Facts (continued)

PRINCIPAL DISPLAY PANEL

Sunscreen 1

PRINCIPAL DISPLAY PANEL

Sunscreen 3

PRINCIPAL DISPLAY PANEL

Sunscreen 4

PRINCIPAL DISPLAY PANEL

Sunscreen 2