Label: BULL FROG MOSQUITO COAST SPL 50 PUMP- avobenzone, homosalate, octisalate, oxybenzone, octyl methoxycinnamate 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 November 5, 2018

If you are a consumer or patient please visit this version.

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  • SPL UNCLASSIFIED SECTION

    Item Number: 31783-700-DM06

    NDC Number: 70281-314-12

    Product Name: Bull Frog Mosquito Coast SPF 50 Pump 

  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, Octyl Methoxycinnamate 7.5%

  • Purpose

    Sunscreen

  • Use

    • 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.

    • When using this product

    keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if

    rash occurs.

    • Flammable: • do not puncture or incinerate

    • Keep out of reach of children.

    If 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
    • children under 6 months: ask a doctor
  • Other information

    • protect the product in this container from excessive heat and direct sun
  • Inactive Ingredients

    Acrylates/Octylacrylamide Copolymer, SD Alcohol 40 (47% w/w), Aloe Barbadensis Leaf Oil, C12-15 Alkyl Benzoate, Fragrance, Tocopheryl (Vitamin E) Acetate

    Questions or comments?

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

    INSECT REPELLENT DIRECTIONS FOR USE: It is a violation of Federal law to use this product in a manner inconsistent with its labeling. Apply liberally and evenly over dry, exposed skin. Do not spray directly on face. Spray on palm of hand and apply to face. An adult must apply this product to children under 10. For continued protection from mosquitoes, re-apply after 8 hours. Do not exceed 7 applications per day for adults, 3 applications per day for children.

    PRECAUTIONARY STATEMENTS: HAZARDS TO HUMANS: CAUTION: For external use only. Causes moderate eye irritation. Do not get in eyes. Use on children under 6 months of age only with the advice of a physician.

    PHYSICAL OR CHEMICAL HAZARDS: Flammable. Keep away from heat and open flame. Contains alcohol. Avoid contact with plastics.  

    FIRST AID

    If in eyes: 

    • Hold eye open and rinse slowly and gently with water for 15-20 minutes.
    • Remove contact lenses, if present, after the first 5 minutes, then continue rinsing the eye.
    • Call a poison control center or doctor for treatment advice.

    Have the product container or label with you when calling a poison control center or doctor, or going for treatment. You may also contact 1-877-800-5553 for emergency medical treatment information.

    STORAGE:

    Store in a cool, dry place in tightly closed container.

    DISPOSAL: Do not Puncture or Incinerate! If empty: Nonrefillable container. Do not reuse or refill this container. Place in trash or offer for recycling if available. If partly filled: Call your local solid waste agency or 1-800-CLEANUP for disposal instructions.

    MAY STAIN SOME FABRICS, PLASTICS AND WOOD SURFACES.

    EPA Reg. No.: 11525-78-91874

    EPA Est. No.: 54487-GA-001

  • PRINCIPAL DISPLAY PANEL

    Bull
    Frog
    Mosquito Coast SPF 50
    Sunscreen + Insect Repellent
    PRINCIPAL DISPLAY PANEL Bull Frog Mosquito Coast SPF 50 Sunscreen + Insect Repellent

  • INGREDIENTS AND APPEARANCE
    BULL FROG MOSQUITO COAST SPL 50 PUMP 
    avobenzone, homosalate, octisalate, oxybenzone, octyl methoxycinnamate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 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) OCTOCRYLENE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-314-12138 g in 1 CAN; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/01/2018
    Labeler - SolSkyn Personal Care LLC (080010329)
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