Label: LIP BALM COFFEE FLAVORED- spf 15 lipstick

  • Category: HUMAN OTC DRUG LABEL

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 March 1, 2017

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  • Purpose

    Purpose

    Sun Screen

  • Drug Facts

    Octinoxate 3.6%

    Octisalate 2.5%

    Benzophenone 1.5%

  • Inactive Ingredients

    Hydrogenated Soybean Oil, Sunflower Oil, White Beeswax Pastilles, Cocoa Butter, Shea Butter, Vitamin E, Aloe Vera Gel, Coffee Flavoring.

  • Warnings

    • Skin Cancer/Skin Aging Alert: Spending too much time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only 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 ask doctor if rash occurs.
    • When using this product keep out of eyes.
    • Keep out of reach of children. If swallowed get medical help or contact posion control center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Use a water resistant sunscreen if swimming or sweating
    • Reapply every 2 hours
    • Children under 6 months : Ask a doctor

  • Storage and Handling Information

    Protect this product from excessive heat and direct sun

  • COFFEE FLAVORED SPF 15 NATURAL BEESWAX LIP BALM

    Coffee

  • INGREDIENTS AND APPEARANCE
    LIP BALM COFFEE FLAVORED 
    spf 15 lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70445-255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.6 g  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorCOFFEEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70445-255-015 g in 1 TUBE; Type 0: Not a Combination Product09/11/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/01/2009
    Labeler - Webb Business Promotions (154445647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Webb Business Promotions154445647manufacture(70445-255)
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