Label: LIP BALM VANILLA FLAVORED- spf 30 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 January 4, 2022

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  • Purpose

    Purpose

    Sun Screen

  • Drug Facts

    Octinoxate 7.5%

    Homosalate 6.0%

    Oxybenzone 6.0%

    Meradimate 4.0%

  • Inactive Ingredients

    Hydrogenated Soybean Oil, Sunflower Oil, Yellow Bees Wax Pearls, Cocoa Butter, Shea Butter, Vitamin E, Aloe Vera Gel, Bacon 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

  • SPF 30 NATURAL BEESWAX LIP BALM VANILLA FLAVORED Dist. by ASI#95838 Eagan Mn 55121 Made in USA

    30 Van

  • INGREDIENTS AND APPEARANCE
    LIP BALM VANILLA FLAVORED 
    spf 30 lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70445-165
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE WAX (UNII: 7G1J5DA97F)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70445-165-015 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(70445-165)
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