Label: WET N WILD JUICY LIP BALM- octinoxate octocrylene oxybenzone 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 November 13, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 7.5%
    Octocrylene 7%
    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: Pentaerythrityl Tetraisostearate, Bis-Diglyceryl Polyacyladipate-2, Ethylhexyl Isononanoate, Propylheptyl Caprylate, Ozokerite, Tridecyl Trimellitate, Mineral Oil/Huile minérale, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate,  Diisostearyl Malate, Polyethylene, Euphorbia Cerifera (Candelilla) Wax/Cire de candelilla, Beeswax/Cire d’abeille, Ricinus Communis (Castor) Seed Oil, Caprylyl Glycol, Hydrogenated Styrene/Isoprene Copolymer, Caprylic/Capric Triglyceride, Persea Gratissima (Avocado) Oil, Sorbic Acid, Tocopheryl Acetate, Stearic Acid, Alumina, Laminaria Ochroleuca Extract, BHT, Fragrance/Parfum
    (MAY CONTAIN/PEUT CONTENIR): Blue 1 Lake/CI 42090, Red 7 Lake/CI 15850, Red 28 Lake/CI 45410, Titanium Dioxide/CI 77891, Yellow 6 Lake/CI 15985, Yellow 10 Lake/CI 47005, Zinc Oxide/CI 77947)
  • PRINCIPAL DISPLAY PANEL

    Package Label
    image of package label

  • INGREDIENTS AND APPEARANCE
    WET N WILD  JUICY LIP BALM
    octinoxate octocrylene oxybenzone lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.0 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    CERESIN (UNII: Q1LS2UJO3A)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SORBIC ACID (UNII: X045WJ989B)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-101-267.5 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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