Label: BULLFROG SPF50 WATER SPORT- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL

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 February 16, 2018

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  • SPL UNCLASSIFIED SECTION

    BullFrog SPF50 Water Sport Lotion

  • 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.

    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
  • Inactive Ingredients

    Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Diisopropyl Adipate, Dimethyl Capramide, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Macrocystis Pyrifera Extract, Phenoxyethanol, Polyester-8, Polyisobutene, Propylene Glycol, Silica, Sorbitan Oleate, Tocopheryl (Vitamin E) Acetate, Triethanolamine, Water

  • 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
    WATER SPORT
    with Water Armor TECH
    Lotion
    50
    BROAD SPECTRUM SPF 50
    5 FL OZ (147 mL)

    PRINCIPAL DISPLAY PANEL BULL FROG SUNSCREEN WATER SPORT with Water Armor TECH Lotion 50 BROAD SPECTRUM SPF 50 5 FL OZ (147 mL)

  • INGREDIENTS AND APPEARANCE
    BULLFROG SPF50 WATER SPORT 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-324
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 mg  in 100 mg
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-324-13147 mg in 1 BOTTLE; 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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