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mally Lip Defender (MallyGirl, LLC)

Available Formats

Dosage Form Package Information Links
GEL 1 TUBE, WITH APPLICATOR in 1 BOX (76119-5305-1) > 3.5 g in 1 TUBE, WITH APPLICATOR Label Information

Complete mally Lip Defender Information

  • DRUG FACTS



  • Active Ingredients

    Avobenzone 2.0%

    Octinoxate 7.0%


  • Purpose

    Sunscreen

    Sunscreen


  • 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.

  • WARNINGS

    For external use only


  • DO NOT USE

    Do not use on damaged or broken skin.


  • STOP USE

    Stop use and ask doctor if rash occurs.


  • WHEN USING

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


  • 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.


  • 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

  • Inactive Ingredients

    Polybutene, Helianthus annuus (sunflower) seed oil, Polyglyceryl-2  triisostearate, Octyldecanol, Euphorbia cerifera (candelilla) wax (candelilla cera), Trihydroxystearin, Copernicia cerifera (carnauba) wax (cera carnauba),  Microcrystalline wax (microcristallina cera), Phospholipids, Calcium aluminum borosilicate, Calcium sodium borosilicate, Tocopheryl acetate, Silica, Sodium chondroitin sulfate, Saccharomyces cerevisiae extract, Hyaluronic acid, Tocopherol, Alumina, Tripeptide-29, Tin oxide, Titanium dioxide (CI 77891) May Contain: Mica (CI 77019), Red 28 Lake (CI 45410), Yellow 5 Lake (CI 19140), Red 6 (CI 15850), Red 7 Lake (CI 15850), Yellow 6 Lake (CI 15985), Iron Oxides (CI 77491, CI 77492, CI 77499), Blue 1 Lake (CI 42090)


  • Other Information

    • Protect this product from excessive heat and direct sun.

  • Principal Display Panel

    mally

    Lip Defender
    Empowering Pink
    duos with sunscreen
    Broad Spectrum SPF 15

    Tube Label
    Drug Facts Label Carton






  • INGREDIENTS AND APPEARANCE
    MALLY LIP DEFENDER 
    avobenzone, octinoxate gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:76119-5305
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.07 g  in 3.5 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE .245 g  in 3.5 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    OCTYLDECANOL (UNII: 07UG7TSU58)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76119-5305-1 1 in 1 BOX
    1 3.5 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 05/01/2012
    Labeler - MallyGirl, LLC (167262554)