WET N WILD MEGASHIELD (OCTINOXATE OXYBENZONE) LIPSTICK [MARKWINS BEAUTY PRODUCTS, INC ]

WET N WILD MEGASHIELD (OCTINOXATE OXYBENZONE) LIPSTICK [MARKWINS BEAUTY PRODUCTS, INC ]
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NDC 12027-100-10
Set ID f277e861-db70-4489-9d7f-d1cab95ac3b8
Category HUMAN OTC DRUG LABEL
Packager Markwins Beauty Products, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 7.5%
    Oxybenzone 2%
  • PURPOSE

    Purpose: Sunscreen
  • INDICATIONS & USAGE

    Use Helps prevent sunburn
  • WARNINGS

    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 skin aging.

    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

    Stop use and ask a doctor if rash occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
    If product is swallowed, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions
    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients: Ozokerite, Pentaerythrityl Tetraisostearate, Octyldodecanol, Bis-Diglyceryl Polyacyladipate-2, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Propylheptyl Caprylate, Caprylic/Capric Triglyceride, VP/Hexadecene Copolymer, Microcrystalline Wax/Cire microcristalline, Polysilicone-6, Tridecyl Trimellitate, Caprylyl Glycol, Sorbic Acid, Oryza Sativa (Rice) Germ Oil, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Alumina, Stearic Acid
    (MAY CONTAIN/PEUT CONTENIR): Carmine/CI 75470, Iron Oxides/CI 77491, CI 77492, CI 77499, Mica, Red 7 Lake/CI 15850, Red 28 Lake/CI 45410, Red 30 Lake/CI 73360, Titanium Dioxide/CI 77891, Yellow 5 Lake/CI 19140, Yellow 6 Lake/CI 15985, Zinc Oxide/CI 77947)
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    WET N WILD  MEGASHIELD
    octinoxate oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CERESIN (UNII: Q1LS2UJO3A)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    RICE GERM OIL (UNII: D4H5GGS5JF)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCHINEAL (UNII: TZ8Z31B35M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-100-103.1 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2011
    Labeler - Markwins Beauty Products, Inc (135407760)
    Establishment
    NameAddressID/FEIBusiness Operations
    Markwins International Corp.544845621manufacture

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