NDC Code(s) : 76209-123-01
Packager : Market America

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 Plus HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76209-123
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE100 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE26 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
PEG/PPG-17/6 COPOLYMER(UNII: P5QZM4T259)
ALCOHOL(UNII: 3K9958V90M)
CETYL ALCOHOL(UNII: 936JST6JCN)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ISOHEXADECANE(UNII: 918X1OUF1E)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
ADENOSINE(UNII: K72T3FS567)
TEPRENONE(UNII: S8S8451A4O)
LONICERA CAPRIFOLIUM FLOWER(UNII: 5N1WD9784U)
JUJUBE FRUIT(UNII: G55HNL2C70)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
HYDROGENATED PALM GLYCERIDES(UNII: YCZ8EM144Q)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PANTHENOL(UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76209-123-011 in 1 CARTON 19/12/2017
1100 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 05/03/2011

LABELER - Market America(797412236)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(76209-123)

PRINCIPAL DISPLAY PANEL

cellular laboratories   De-Aging Sunscreen Broad Spectrum SPF 50+   net vol. 3.4 fl. oz/100 mL

PRINCIPAL DISPLAY PANEL

Outer Label