NDC Code(s) : 0363-3112-04
Packager : Walgreens

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SHEER SPF 55 Avobenzone - 3.00% Homosalate - 10.00% Octisalate - 5.00% Octocrylene - 2.75% Oxybenzone - 6.00% LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-3112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		Avobenzone3 g in 100 mL
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate10 g in 100 mL
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate5 g in 100 mL
Octocrylene(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		Octocrylene2.75 g in 100 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		Oxybenzone6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
DOCOSANOL(UNII: 9G1OE216XY)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Butyloctyl Salicylate(UNII: 2EH13UN8D3)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
Dimethicone(UNII: 92RU3N3Y1O)
Dimethyl Capramide(UNII: O29Y6X2JEZ)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Ethylhexyl Stearate(UNII: EG3PA2K3K5)
Ethylhexylglycerin(UNII: 147D247K3P)
Ethylparaben(UNII: 14255EXE39)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
Iodopropynyl Butylcarbamate(UNII: 603P14DHEB)
Methylparaben(UNII: A2I8C7HI9T)
PEG-100 Stearate(UNII: YD01N1999R)
Phenoxyethanol(UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)(UNII: T9296U138P)
Propylparaben(UNII: Z8IX2SC1OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Trideceth-6(UNII: 3T5PCR2H0C)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER(UNII: KFR5QEN0N9)
Water(UNII: 059QF0KO0R)
Xanthan Gum(UNII: TTV12P4NEE)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-3112-04118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 07/15/2012

PRINCIPAL DISPLAY PANEL

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