SUPER LYSINE PLUS TANGERINE LIP TREATMENT (OCTINOXATE AND OXYBENZONE) LIPSTICK [QUANTUM, INC.]

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SUPER LYSINE PLUS TANGERINE LIP TREATMENT (OCTINOXATE AND OXYBENZONE) LIPSTICK [QUANTUM, INC.]
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NDC 70084-230-01
Set ID 8a00194e-9e28-4257-82e5-59bc44f7897d
Category HUMAN OTC DRUG LABEL
Packager Quantum, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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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 protect against sunburn and chapped lips.

  • 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.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • 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) Leaf, Lysine, Melaleuca Alternifolia (Tea Tree) Oil, Melaleuca Cajuputi (Cajeput) Oil, Natural Flavor, 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).

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: QUANTUM, INC. PO BOX 2791, EUGENE, OR 97402

  • PRINCIPAL DISPLAY PANEL - 5 g Cylinder Label

    Quantum®
    HEALTH

    PEEL LABEL
    FOR DRUG FACTS

    SuperLysine+®

    Tangerine Flavor
    LIP TREATMENT & PROTECTANT

    NET WT 5g / .17 OZ

    SPF 21
    SUNSCREEN

    PRINCIPAL DISPLAY PANEL - 5 g Cylinder Label
  • INGREDIENTS AND APPEARANCE
    SUPER LYSINE PLUS TANGERINE LIP TREATMENT 
    octinoxate and oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70084-230
    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
    ColorWHITE (Brownish-White) Score    
    ShapeSize
    FlavorTANGERINEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70084-230-015 g in 1 CYLINDER; Type 0: Not a Combination Product04/02/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/02/2001
    Labeler - Quantum, Inc. (044806305)
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