Label: BULLFROG LAND SPORT SPF 50 QUIK- homosalate, octinoxate, octisalate, octocrylene, zinc oxide stick

  • 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 August 16, 2017

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  • SPL UNCLASSIFIED SECTION

    BullFrog Land Sport SPF 50 Quik Stik

  • Active Ingredients

    Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, Zinc Oxide 10%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn

    • if used as directed with other sun 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.

    • When using this product

    keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure

    • re-apply:

          • after 80 minutes of swimming or sweating

          • 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 broad spectrum SPF of 15 or higher and other sun protection measures including:

          • limit time in the sun, especially from 10 a.m.-2 p.m.

          • wear long-sleeved shirts, pants, hats and sunglasses

    • children under 6 months: ask a doctor

  • Other information

    • protect this product from excessive heat and direct sun

    • for use on skin only. Avoid contact with fabric

  • Inactive Ingredients

    Aloe Barbadensis (Aloe) Leaf Extract, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cera Alba (Beeswax), Dimethicone, Ethylhexyl Palmitate, Glycine Soja (Soybean) Oil, Isopropyl Myristate, Ozokerite, Polyethylene, Triethoxycaprylylsilane

  • Questions or comments?

    www.bullfrogsunscreen.com or call 1-800-715-3485 (USA)

  • PRINCIPAL DISPLAY PANEL

    Bull Frog
    Sunscreen
    Land sport Clear Zinc
    Quik Stik
    On the Go
    Face and Body
    SPF 50

    PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen Land sport Clear Zinc Quik Stik On the Go Face and Body SPF 50

  • INGREDIENTS AND APPEARANCE
    BULLFROG LAND SPORT SPF 50 QUIK 
    homosalate, octinoxate, octisalate, octocrylene, zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 mg  in 100 mg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 mg  in 100 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CERESIN (UNII: Q1LS2UJO3A)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-337-0318 mg in 1 CONTAINER; Type 0: Not a Combination Product09/15/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/15/2015
    Labeler - SolSkyn Personal Care LLC (080010329)
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