Label: GLYCOLIC DAY CREAM SPF 30- homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream

  • Category: HUMAN OTC DRUG LABEL

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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  • Active ingredients

    Active ingredients           Purpose

    Homosalate 10.0% . . . . . Sunscreen

    Octisalate 5.0% . . . . . . .  Sunscreen

    Oxybenzone  5.0% . . . . .Sunscreen

    Avobenzone  3.0% . . . .Sunscreen

    Octocrylene  2.0% . . . . Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  Do not swallow.  If swallowed, get medical help or contact a Posion Control Center right away.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GLYCOLIC DAY CREAM SPF 30 
    homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-0032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate0.1 mL  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 mL  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.02 mL  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.05 mL  in 1 mL
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.03 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-0032-21 in 1 BOX
    1NDC:68634-0032-130 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/04/2010
    Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health and Beauty Solutions, Inc.164589371manufacture, label
    Establishment
    NameAddressID/FEIBusiness Operations
    JKA Incorporated621539352pack