Label: MALLY PERFECT PREP PORELESS PRIMER - avobenzone and octinoxate cream

  • NDC Code(s): 76119-1170-1, 76119-1170-2
  • Packager: MallyGirl, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 07/13

If you are a consumer or patient please visit this version.

  • DRUG FACTS
  • Active Ingredients

    Avobenzone 2.0%

    Ocitnaxate 7.5%

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  • Purpose

    Sunscreen

    Sunscreen

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  • Use

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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  • WARNINGS

    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin.

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  • STOP USE

    Stop use and ask doctor if rash occurs.

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  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swollowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor
    • Sun Protection Measures. Spending time in the sun increases risk of skin cancer and early aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higer and other sun protection measures including
    • Limit time in the sun especially from 10:00 a.m. - 2:00 p.m.
    • Wear long sleeved shirts, pants, hats and sunglasses
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  • Inactive Ingredients

    Cyclopentasiloxane, Dimethicone/Vinyl Dimeticone Crosspolymer, Cyclomethicone, Hydrogenated Vegetable Oil, C12-15 Alkyl Benzoate, Peg/Ppg-18/18 Dimethicone, Polymethylsilsesquioxane, Tocopheryl Acetate, Glycyrrhiza Glabra (Licorice) Root Extract, Silica, PEG-10 Rapeseed Sterol, Ceramide 2, Atelocollagen, Tribehenin, Palmitoyl Oligopeptide, Silica Dimethyl Silylate, Sodium Chondroitin Sulfate, Pentaerythrityl Tetraisostearate, Ethylthexyl Palmitate, Disteardimonium Hectorite, Propylene Carbonate, Phenoxyethanol, Mica, Titanium Dioxide (CI 77891), Red 17 (CI 26100), Bismuth Oxychloride (CI 77163). Product made in the USA

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  • Other Information

    • Protect this product from excessive heat and direct sun.
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  • SPL UNCLASSIFIED SECTION

    Prices and availability are subject to change without notice.

    Prices shown do not include shipping, handling, and applicable sales tax.

    QVC and QVC.com are registered trademarks of ER Marks, Inc.

    Distributed by Mallygirl LLC - P.O. Box 42727 - Baltimore, MD 21284-2727

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  • Principal Display Panel

    mally

    Perfect Prep

    Poreless Primer

    with sunscreen

    Broad Spectrum

    SPF15

    Tube Label
    Jar Label

    Drug Facts Label Carton
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  • INGREDIENTS AND APPEARANCE
    MALLY PERFECT PREP PORELESS PRIMER  
    avobenzone, octinoxate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76119-1170
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.6 g  in 30.0 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 2.25 g  in 30.0 mL
    Inactive Ingredients
    Ingredient Name Strength
    CYCLOMETHICONE 5  
    DIMETHICONE  
    CYCLOMETHICONE  
    CORN OIL  
    ALKYL (C12-15) BENZOATE  
    POLYETHYLENE GLYCOL 900  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS)  
    ALPHA-TOCOPHEROL ACETATE  
    GLYCYRRHIZA GLABRA  
    PEG-10 RAPESEED STEROL  
    CERAMIDE 2  
    TRIBEHENIN  
    PALMITOYL OLIGOPEPTIDE  
    SILICA DIMETHYL SILYLATE  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)  
    PROPYLENE CARBONATE  
    PHENOXYETHANOL  
    MICA  
    TITANIUM DIOXIDE  
    D&C RED NO. 17  
    BISMUTH OXYCHLORIDE  
    SILICON DIOXIDE  
    PENTAERYTHRITYL TETRAISOSTEARATE  
    ETHYLHEXYL PALMITATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76119-1170-1 1 in 1 BOX
    1 30 mL in 1 TUBE
    2 NDC:76119-1170-2 1 in 1 BOX
    2 28.3 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 03/29/2012
    Labeler - MallyGirl, LLC (167262554)
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