Label: ADVANCED PROTECTION- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 5, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 7.5%sunscreen
    Zinc Oxide 5%sunscreen
  • Uses

    • provides moderate sun protection
  • Warnings

    • for external use only
    • for adult use only

    When using this product

    • keep out of eyes. If contact occurs rinse with water to remove.

    • Stop use if irritation occurs.

    • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
  • Directions

    • Apply liberally 20 minutes before sun exposure and reapply as needed.
    • Children under 6 months of age: ask a physician.
  • Inactive ingredients

    Beeswax, Bis-PEG-12 Dimethicone, Butylparaben, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Chrondrus Crispus (Carrageenan), Copernicia Cerifera (Carnauba) Wax, Cyclomethicone, Dicaprylyl Maleate, Dimethicone, Ethylparaben, Glycol Stearate, Glycyrrhiza Glabra (Licorice) Extract, Isobutylparaben, Laureth-7, Lecithin, Methylparaben, PEG-100 Stearate, PEG-20, Phenoxyethanol, Plankton Extract, Polyacrylamide, Propylparaben, Sorbitan Tristearate, Steareth-100, Stearyl Alcohol, Synthetic Beeswax, Tocopheryl Acetate, VP/Eicosene Copolymer, Water (Aqua), Xanthan Gum

  • PRINCIPAL DISPLAY PANEL - 56.7 g Carton

    Moisture Defense
    SPF 15

    Net Wt 2 Oz/56.7 g

    Principal Display Panel - 56.7 g Carton
  • INGREDIENTS AND APPEARANCE
    ADVANCED PROTECTION   SPF-15
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIOCTYL MALEATE (UNII: OD88G8439L)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24623-001-2056.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35208/25/2001
    Labeler - CBI Laboratories, Inc (623704368)
    Establishment
    NameAddressID/FEIBusiness Operations
    CBI Laboratories623704368MANUFACTURE
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