Label: BULLFROG SPF50 LAND SPORT C-SPRAY- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

  • 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 7, 2017

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  • SPL UNCLASSIFIED SECTION

    Product

    BullFrog SPF50 Land Sport C-Spray      

  • Active Ingredients

    Avobenzone 2%, Homosalate 10%, Octisalate 5%, Octocrylene 2%, Oxybenzone 5%

  • 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
    • Flammable: keep away from fire or flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

    Do not use

    • on damaged or broken skin.

    When using this product:

    • keep away from face to avoid breathing in
    • 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 swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • shake well. Hold can 4-6 inches from skin to apply.
    • spray liberally and spread evenly by hand 15 minutes before sun exposure on all exposed areas. Ensure skin is completely covered with product.
    • do not spray directly on face. Spray on hands then apply to face.
    • do not apply in windy conditions.
    • use in a well-ventilated area.
    • 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 a 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

    • for use on skin only
    • protect this product from excessive heat and direct sun
  • Inactive Ingredients

    Acacia Farnesiana Extract, Acrylates/Octylacrylamide Copolymer, Camellia Oleifera (Green Tea) Leaf Extract, Chamomile Flower Extract, Dimethyl Capramide, Fragrance, Glycerin, Isopropyl Myristate, Lavender Extract, Polyester-8, Propylene Glycol, Rosemary Leaf Extract, SD Alcohol 40 (71.45% w/w)

  • Questions or comments?

    www.bullfrogsunscreen.com or call toll-free 1-800-715-3485

    MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

  • PRINCIPAL DISPLAY PANEL

    Bull Frog
    Sunscreen
    Landsport
    SPF 50

    PRINCIPAL DISPLAY PANEL Bull Frog Sunscreen Landsport SPF 50

  • INGREDIENTS AND APPEARANCE
    BULLFROG SPF50 LAND SPORT C-SPRAY 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-333-11170 g 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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