Label: AVA ISA SUN LIP SUN WHIP WATERMELON LILY- zinc oxide cream

  • NDC Code(s): 71644-011-10
  • Packager: Cyberderm Laboratories inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide* 20%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • 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

    Warnings

    For external use only.

    Do not use on damaged or broken skin.

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

    Stop use and ask a doctor if rash occurs.

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children over 6 months of age
    • Apply liberally to face and body 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water-resistant sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • Protect this product from excessive heat and direct sun
  • INACTIVE INGREDIENT

    Inactive ingredients

    Caprylic/Capric Triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable Oil, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Polyhydroxystearic Acid, Behenyl Behenate, Polyglyceryl-10 Stearate, Sodium Stearoyl Lactylate, Glyceryl Isostearate, Tocopherol. May contain: CI 15850, Aluminum Hydroxide

  • QUESTIONS

    Questions?
    718-481-2628. Monday-Friday, 9 am - 5 pm

  • SPL UNCLASSIFIED SECTION

    Distributed by

    Cyberderm Laboratories, Inc.

    650-1600 Carling Avenue

    Ottawa, ON K1Z 1G3

    Canada

    Made in Canada

  • PRINCIPAL DISPLAY PANEL

    AVA ISA
    Sun Lip
    Sun Whip®
    Watermelon Lily
    melt-on-contact all mineral lip balm
    SPF 15 Broad Spectrum
    UVA/UVB Protection
    made with 20% zinc oxide
    10 ml (.33 fl oz)
    NPN 80097041

    AvaIsa LipBalm WatermelonLily

  • INGREDIENTS AND APPEARANCE
    AVA ISA SUN LIP SUN WHIP  WATERMELON LILY
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71644-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    CORN OIL (UNII: 8470G57WFM)  
    HYDROGENATED PALM OIL (UNII: 257THB963H)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71644-011-101 in 1 CARTON06/19/2020
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/18/2020
    Labeler - Cyberderm Laboratories inc. (242524267)
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