FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15 (ETHYLHEXYL METHOXYCINNAMATE) LIPSTICK [TWEEN BRANDS INC]

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FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15 (ETHYLHEXYL METHOXYCINNAMATE) LIPSTICK [TWEEN BRANDS INC]
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NDC 60637-116-00
Set ID e0d1b2b5-9508-4cd8-95e6-6e5fe2aafac4
Category HUMAN OTC DRUG LABEL
Packager Tween Brands Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredient

    Ethylhexyl Methoxycinnamate 3.5%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • Warning

    • 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 the reach of children

    If product is swallowed get medical help or contact a Poison Control Center in area.

  • Directions

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
  • Inactive Ingredients

    Mineral Oil, Ozokerite, Ethylhexyl Palmitate, Polybutene, Cera alba, Synthetic wax, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Extract, Fragrance, Tocopheryl acerare.

  • Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15

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  • INGREDIENTS AND APPEARANCE
    FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15 
    ethylhexyl methoxycinnamate lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60637-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE122.5 mg  in 3.5 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60637-116-001 in 1 BOX09/02/2016
    13.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/02/2016
    Labeler - Tween Brands Inc (965758188)
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