Label: BULL FROG WATER ARMOR SUPER 40- meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 July 18, 2014

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  • Active Ingredients

    • Meradimate: 5%
    • Octinoxate: 7.5%
    • Octisalate: 5%
    • Octocrylene: 10%
    • Oxybenzone: 6%
    • Titanium Dioxide: 4.5%
  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
  • 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 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 a doctor if rash occurs. When using this product keep out of eyes.  Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Children under 6 months: Ask a doctor
  • Other Information

    • For use on skin only
    • Avoid contact with fabric
    • Protect this product from excessive heat and direct sun
  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    BULL FROG WATER ARMOR SUPER 40 
    meradimate, octinoxate, octisalate, octocrylene, oxybenzone, titanium dixoide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-649
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MERADIMATE (UNII: J9QGD60OUZ) (MERADIMATE - UNII:J9QGD60OUZ) MERADIMATE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    PEG-40 SORBITAN STEARATE (UNII: X61U1UH01B)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
    NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-649-05147 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2013
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-649)
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