NDC Code(s) : 0363-3222-04
Packager : Walgreens

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sheer SPF 100 Avobenzone 3.00% Homosalate 15.00% Octisalate 5.00% Octocrylene 10.00% Oxybenzone 6.00% LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0363-3222
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) 		Homosalate15 g in 100 mL
Octisalate(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		Octisalate5 g in 100 mL
Octocrylene(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		Octocrylene10 g in 100 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		Oxybenzone6 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
YELLOW WAX(UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Butyloctyl Salicylate(UNII: 2EH13UN8D3)
Chlorphenesin(UNII: I670DAL4SZ)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
Dimethyl Capramide(UNII: O29Y6X2JEZ)
GLYCYRRHIZINATE DIPOTASSIUM(UNII: CA2Y0FE3FX)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Ethylhexylglycerin(UNII: 147D247K3P)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
Methylisothiazolinone(UNII: 229D0E1QFA)
PEG-100 Stearate(UNII: YD01N1999R)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)(UNII: T9296U138P)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
TROLAMINE(UNII: 9O3K93S3TK)
Water(UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 809Y72KV36)
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER(UNII: 7K68DGG29P)
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER(UNII: 39DK5WQ2PR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-3222-04118 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/15/2012

PRINCIPAL DISPLAY PANEL

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