Label: WET N WILD ULTIMATE MATCH- octinoxate oxybenzone liquid

  • 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 19, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients
    Octinoxate 6%
    Oxybenzone 2%
  • 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.
  • INDICATIONS & USAGE

    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/Ingredients inactifs Water/Eau, Tridecyl Trimellitate, Talc, Isopropyl Myristate, Isododecane, Butylene Glycol, Glycerin, Glyceryl Stearate SE, Sorbitan Sesquioleate, Triacontanyl PVP, Triethanolamine, Stearic Acid, Cetyl Palmitate, Alumina, Sodium Laureth Sulfate, Chlorphenesin, Hydroxyethylcellulose, Acrylates Copolymer, Tocopheryl Acetate, Dipotassium Glycyrrhizate, Disodium EDTA, Xanthan Gum, Caprylic/Capric Triglyceride, Stearyl Glycyrrhetinate, Laminaria Ochroleuca Extract, Sodium Hyaluronate, Methylisothiazolinone
    (MAY CONTAIN/PEUT CONTENIR): Iron Oxides/CI 77491, CI 77492, CI 77499, Titanium Dioxide/CI 77891, Ultramarines/CI 77007 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  ULTIMATE MATCH
    octinoxate oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12027-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mL  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    TALC (UNII: 7SEV7J4R1U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DISODIUM GLYCYRRHIZATE (UNII: L8Q0US0J7V)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12027-102-2929.6 mL in 1 BOTTLE, GLASS
    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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