Label: AGE RENEWAL DEEP WRINKLE MOISTURIZER- homosalate, octisalate, oxybenzone, avobenzone, octocrylene cream

  • 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 9, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:  Homosalate 10%, Octisalate 5%, Oxybenzone 2%, Avobenzone 2%, Octocrylene 1.5%

  • PRINCIPAL DISPLAY PANEL

    FP105front

  • INGREDIENTS AND APPEARANCE
    AGE RENEWAL DEEP WRINKLE MOISTURIZER 
    homosalate, octisalate, oxybenzone, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-0029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.1 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.02 g  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.02 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.015 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-0029-21 in 1 CARTON
    1NDC:68634-0029-142.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/12/2010
    Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss American Products611921669pack