Label: DERMA BLEMISH BALM - octinoxate, titanium dioxide and zinc oxide cream 

  • NDC Code(s): 76344-6001-1, 76344-6001-2
  • Packager: Humex,Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/13

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  • ACTIVE INGREDIENT

    Drug Facts

    Active ingredients                                                                                                  Purpose

    Octinoxate 6.50%(wt) -------------------------------------------------- Sunscreen Agent

    Titanium Dioxide 4.24%(wt) ------------------------------------------------------------------- Sunscreen Agent

    Zinc Oxide 3.50%(wt) --------------------------------------------------------------------------- Sunscreen Agent

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  • WARNINGS AND PRECAUTIONS

    Warning

    For external use only

    When using this product

    ■ Avoid eye area. If contact occurs, rinse eyes thoroughly

    ■ Discontinue use if signs of irritation develops

    Keep out of reach of the children

    Other Information

    ■ store between 20-25 °C (68-77 °F)

    ■ avoid freezing and excessive heat above 40 °C (104 °F)

    ■ close cap after use.

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  • INSTRUCTIONS FOR USE

    Uses

    ■ Helps prevent sunburn

    ■ Provides high protection from sunburn

    ■ Helps brighten skin tone

    ■ Helps improve wrinkles

    ■ Covers blemishes without irritation

    ■ Helps improve skin condition

    Direction

    ■ Evenly apply to the skin whole face at the final stage of skin care. Reapply it at anytime (before and after makeup) as needed.

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  • INACTIVE INGREDIENT

    Inactive Ingredient

    ■ Water ■ Cetyl Ethylhexanoate ■ Propylene Glycol ■ Cyclomethicone ■ Isononyl Isononanoate ■ Cetyl PEG/PPG-10/1 Dimethicone ■ Cyclopentasiloxane ■ Talc ■ Sorbitan Sesquioleate ■ Mineral Oil ■ Caprylic/Capric Triglyceride ■ Zinc Stearate ■ Microcrystalline Wax ■ Hexyl Laurate ■ Quaternium-18 Bentonite ■ Magnexium Sulfate ■ Dimethicone Copolyol ■ Dimethicone ■ Methyl Methacrylate Crosspolymer ■ Alumina ■ Silica ■ Butylene Glycol ■ Allantoin ■ Portulaca Oleracea Extract ■ chamomilla Recutita (Matricaria) Flower Extract ■ Aloe Barbadensis Leaf Extract ■ Sodium Hyaluronate ■ Adenosine ■ Triethoxycaprylylsilane ■ CI 77491 ■ CI 77492 ■ CI77499 ■ Phenoxyethanol ■ Arbutin

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  • INGREDIENTS AND APPEARANCE
    DERMA BLEMISH BALM  
    octinoxate, titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76344-6001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTINOXATE (OCTINOXATE) OCTINOXATE 6.5 g  in 100 mL
    Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 4.24 g  in 100 mL
    Zinc Oxide (Zinc Oxide) Zinc Oxide 3.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    Cetyl Ethylhexanoate  
    Propylene Glycol  
    Cyclomethicone  
    Isononyl Isononanoate  
    Talc  
    Sorbitan Sesquioleate  
    Mineral Oil  
    Zinc Stearate  
    Microcrystalline Wax  
    Hexyl Laurate  
    Dimethicone  
    Allantoin  
    Adenosine  
    Triethoxycaprylylsilane  
    Phenoxyethanol  
    ARBUTIN  
    Product Characteristics
    Color brown (Yellowish brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76344-6001-2 1 in 1 BOX
    1 NDC:76344-6001-1 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 04/22/2013
    Labeler - Humex,Inc. (017945311)
    Establishment
    Name Address ID/FEI Business Operations
    Hunusbio Inc 557795012 manufacture(76344-6001)
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