Label: ELEVEN PERFECT FORM TINTED LIP BALM VENUS- zinc oxide cream

  • NDC Code(s): 71644-015-10
  • Packager: Cyberderm Laboratories inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Zinc Oxide 20%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses

    • Helps prevent sunburn.
  • WARNINGS

    Warnings

    • For external use only.

    • Do not use on damaged or broken skin.

    • Stop use and ask a doctor if rash occurs.

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

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

    Directions

    • Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
  • 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: Red 7, Aluminum Hydroxide, Curcuma Longa (Turmeric) Root Extract, Acacia Senegal Gum, Maltodextrin, Beta Vulgaris (Beet) Root Extract, Citric Acid, Ascorbic Acid, Ipomoea Batatas Root Extract, Red 6, Monoammonium Glycyrrhizinate

  • STORAGE AND HANDLING

    Other information

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics.
    • 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 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
    • Children under 6 months of age: ask a doctor
  • QUESTIONS

    Questions or Comments?
    718-481-2628.

  • SPL UNCLASSIFIED SECTION

    DIST. BY CYBERDERM LABORATORIES

    650-1600 CARLING AVE

    OTTAWA ON CANADA K1Z 1G3

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    ELEVEN BY VENUS
    PERFECT FORM TINTED LIP BALM
    SPF 15

    100% Mineral Broad Spectrum
    VENUS

    20% Zinc Oxide

    Sunscreen Lip Balm

    UVA/UVB Protection
    10ML / 0.34 FL. OZ.

    Eleven-LipBalm-Venus

  • INGREDIENTS AND APPEARANCE
    ELEVEN PERFECT FORM TINTED LIP BALM  VENUS
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71644-015
    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
    MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M)  
    TURMERIC (UNII: 856YO1Z64F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    BEET (UNII: N487KM8COK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    D&C RED NO. 6 (UNII: 481744AI4O)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    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)  
    SWEET POTATO (UNII: M9WGG9Z9GK)  
    ACACIA (UNII: 5C5403N26O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71644-015-101 in 1 CARTON01/14/2021
    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 DrugM02001/14/2021
    Labeler - Cyberderm Laboratories inc. (242524267)
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