Label: AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER- octinoxate, octisalate, oxybenzone, zinc oxide 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 15, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:  Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%, Zinc Oxide 2%

  • PRINCIPAL DISPLAY PANEL

    FP104front

  • GENERAL PRECAUTIONS

    Caution:  For external use only.  Avoid getting into eyes.  If product gets into eyes, rinse thoroughly with water.  In the beginning you may experience mild tingling, warming, flaking and/or redness.  This is a sign that the product is working.  If discomfort occurs reduce use to every other day until your skin adjusts.  Discontinue use if irritation occurs.

  • STOP USE

    Discontinue use if irritation occurs.

  • INGREDIENTS AND APPEARANCE
    AGE RENEWAL FIRMING AND HYDRATING MOISTURIZER 
    octinoxate, octisalate, oxybenzone, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-0031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.075 g  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.04 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.02 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-0031-21 in 1 CARTON
    1NDC:68634-0031-151 g in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/22/2009
    Labeler - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Registrant - AMCOL Health and Beauty Solutions, Inc. (164589371)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health and Beauty Soltuions, Inc.164589371manufacture, label, pack
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