Label: SUNPLUS LIP LIFE- sunscreen stick

  • NDC Code(s): 65112-303-01, 65112-303-02
  • Packager: I. Shay Cosmetics
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 13, 2024

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  • ACTIVE INGREDIENT

    Octocrylene 3%

    Homosalate2%

    Octisalate 2%

    Avobenzone 2%

  • PURPOSE

    Sunscreen protection

  • KEEP OUT OF REACH OF CHILDREN

    WARNING: Keep out of reach of children.

  • INDICATIONS & USAGE

    Helps prevent sunburn

    Higher SFP gives more sunburn protection

    Retains SPF after 40 minutes of swimming or sweating

    If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the Sun.

  • INACTIVE INGREDIENT

    Coconut oil, Caprylic, BehenylBehenate, Sunflower oil, Carnauba Wax, Candelilla Wax, Flavor, Glycerin, Safflower oil, Stevia, PolyhydroxystearicAcid, Organic Raspberry oil, Organic Jojoba oil, Organic Evening primrose oil, Organic Aloe vera oil, Lanolin acid, Tocopherol Acetate.

  • WARNINGS

    Do not use on damaged or broken skin.

    When using this product keep out of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breastfeeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

    Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

  • PRINCIPAL DISPLAY PANEL

    Sunplus Lip Balm

  • INGREDIENTS AND APPEARANCE
    SUNPLUS LIP LIFE 
    sunscreen stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65112-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.03 g  in 4.2 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.02 g  in 4.2 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.02 g  in 4.2 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.02 g  in 4.2 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65112-303-021 in 1 BOX06/01/2024
    1NDC:65112-303-014.2 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2024
    Labeler - I. Shay Cosmetics (151582384)
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