Label: BULL FROG WATER ARMOR SPORT QUIK 50- avobenzone, homosalate, octisalate, oxybenzone, octocrylene gel

  • 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 March 25, 2014

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  • Active Ingredients

    Homosalate: 15%
    Octisalate: 5%
    Oxybenzone: 6%
    Octocrylene: 10%
    Avobenzone: 3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • If used as directed with other skin protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    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.  Flammable  Keep away from fire or flame.  

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • reapply after 80 minutes of swimming or sweating and immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including limiting time in the sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants hats and sunglasses.
    • 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 SPORT QUIK 50 
    avobenzone, homosalate, octisalate, oxybenzone, octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-653
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-653-05147 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2014
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture(62802-653)
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