Label: GLYCOLIC DAY CREAM SPF 30- homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68634-0032-1, 68634-0032-2 - Packager: AMCOL Health and Beauty Solutions, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 4, 2010
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INGREDIENTS AND APPEARANCE
GLYCOLIC DAY CREAM SPF 30
homosalate, octisalate, octocrylene, oxybenzone, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68634-0032 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 0.1 mL in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 mL in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.02 mL in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.05 mL in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68634-0032-2 1 in 1 BOX 1 NDC:68634-0032-1 30 mL in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/04/2010 Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371) Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371) Establishment Name Address ID/FEI Business Operations AMCOL Health and Beauty Solutions, Inc. 164589371 manufacture, label Establishment Name Address ID/FEI Business Operations JKA Incorporated 621539352 pack