VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 (OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) STICK [BUTH-NA-BODHAIGE, INC.,]

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VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 (OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) STICK [BUTH-NA-BODHAIGE, INC.,]
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NDC 57691-325-42
Set ID 5d6062e5-2518-4daf-a013-161bf1bbca51
Category HUMAN OTC DRUG LABEL
Packager Buth-Na-Bodhaige, Inc.,
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone (2.0% w/w)Sunscreen
    Octisalate (5.0% w/w)Sunscreen
    Octocrylene (3.0% w/w)Sunscreen
  • Uses

    • helps prevent sunburn.
  • Warnings

    • For external use only

    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 occurs.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • 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 sun especially from 10 a.m. – 2 p.m.
      • wear long-sleeved shirts, pants, hats and sunglasses.
    • reapply this product at least every 2 hours.
    • use water resistant sunscreen if swimming or sweating.
    • children under 6 months of age: ask a doctor.
  • Other information

    • protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Ricinus Communis (Castor) Seed Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Hydrogenated Coconut Oil, Euphorbia Cerifera (Candelilla) Wax, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Ammonium Glycyrrhizate, Triticum Vulgare (Wheat) Germ Oil, Vanilla Planifolia Fruit Extract, Calendula Officinalis Flower Extract, Echinacea Purpurea Extract, Tocopherol, Glycine Soja (Soybean) Oil.

  • PRINCIPAL DISPLAY PANEL - 4.2 g Container Label

    THE
    BODY
    SHOP®

    THE BODY SHOP
    VITAMIN E

    MOISTURE-PROTECT
    LIP CARE

    BROADSPECTRUM SPF 15
    SUNSCREEN

    WITH VITAMIN E
    & MOISTURISING WHEATGERM OIL

    ACTIVE INGREDIENTS:
    Avobenzone (2.0%),
    Octisalate (5.0%),
    Octocrylene (3.0%).

    Net wt. 4.2 g (0.14 OZ)

    Peel for Drug Facts

    ALL SKIN TYPES

    Principal Display Panel - 4.2 g Container Label
  • INGREDIENTS AND APPEARANCE
    VITAMIN E MOISTURE-PROTECT LIP CARE SPF 15 
    octisalate, avobenzone, and octocrylene stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57691-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate0.05 g  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone0.02 g  in 1 g
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Hydrogenated Coconut Oil (UNII: JY81OXM1OM)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    VANILLA BEAN (UNII: Q74T35078H)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    ECHINACEA PURPUREA WHOLE (UNII: QI7G114Y98)  
    Tocopherol (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57691-325-424.2 g in 1 CONTAINER; Type 0: Not a Combination Product10/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35210/31/2020
    Labeler - Buth-Na-Bodhaige, Inc., (791071279)
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