Label: LIP CLEAR LYSINE PLUS COLDSTICK- octinoxate and oxybenzone lipstick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 6, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Octinoxate 7.0%Sunscreen
    Oxybenzone (Benzophenone-3) 5.0%Sunscreen
  • Uses

    Helps prevent sunburn

  • Warnings

    • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.

    • Do not use on damaged or broken skin.

    • Stop use and consult a doctor if rash occurs.
    • Avoid contact with eyes. If in eyes, rinse with warm water to remove.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center.
  • 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.
  • Inactive Ingredients

    Beeswax, Calendula Officinalis Extract, Carthamus Tinctorius (Safflower) Seed Oil, Cholecalciferol (Vitamin D), Copernicia Cerifera (Carnauba) Wax, Echinacea Purpurea Extract, Gum Benzoin Tincture, Hydrastis Canadensis (Goldenseal) Extract, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Cajuputi (Cajeput) Oil, Propolis Extract, Purified Water, Retinyl Palmitate (Vitamin A), Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Vitamin E), Tocopheryl Acetate (Vitamin E).

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions?

    800-448-1448 www.quantumhealth.com

  • SPL UNCLASSIFIED SECTION

    Distributed by: QUANTUM, INC.
    PO Box 2791, Eugene, OR 97402

  • PRINCIPAL DISPLAY PANEL - 5 gm Cylinder Blister Pack

    Inspired by Nature

    SPF-21
    Sunscreen

    LIP CLEAR®
    Lysine+®

    Lip Treatment &
    Protectant

    • Softens & Protects
    • Soothes & Moisturizes
    • Chapped Lips
    • Goes on Clear

    Lysine with
    herbs and nutrients

    • WITH HERBS • VITAMINS & OTHER TOPICALS

    QUANTUM® HEALTH

    Net Wt. 5 gm / .17 oz.

    PRINCIPAL DISPLAY PANEL - 5 gm Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    LIP CLEAR LYSINE PLUS COLDSTICK 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate70 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Calendula Officinalis Flower (UNII: P0M7O4Y7YD)  
    Echinacea Purpurea (UNII: QI7G114Y98)  
    Benzoin Resin (UNII: GK21SBA74R)  
    Goldenseal (UNII: ZW3Z11D0JV)  
    Lysine Hydrochloride (UNII: JNJ23Q2COM)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Melaleuca Cajuputi Leaf Oil (UNII: 5O59RMR6DU)  
    Propolis Wax (UNII: 6Y8XYV2NOF)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Safflower (UNII: 4VBL71TY4Y)  
    Cholecalciferol (UNII: 1C6V77QF41)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Water (UNII: 059QF0KO0R)  
    Castor Oil (UNII: D5340Y2I9G)  
    Jojoba Oil (UNII: 724GKU717M)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tocopherol (UNII: R0ZB2556P8)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-210-015 g in 1 CYLINDER; Type 0: Not a Combination Product01/06/1997
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35201/06/1997
    Labeler - Quantum, Inc. (044806305)
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