Label: BULLFROG BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone,octocrylene,homosalate, octinoxate, octisalate spray

  • 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 January 17, 2022

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

    Octinoxate 7.5%

  • Purpose

    Sunscreens

  • Uses

    Helps prevent sunburn

  • Warnings

    Skin Alert

    • Limiting sun exposure, wearing protective clothing and using sunscreen may reduce the risk of skin aging, skin care and other harmful effects of the sun

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

    Flammable Keep away from heat and open flame. Do not puncture or incinerate.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
    • 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 INGREDIENT

    Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Butyl Methoxydibenzoylmethane, C12-15 Alkyl Benzoate, Ethyl Butylacetylaminopropionate, Ethylhexyl Salicylate, Homosalate, Octinoxate (Ethylhexyl Methoxycinnamate), Octocrylene, SD Alcohol 40 (Alcohol Denat.), Tocopheryl Acetate, Water

  • Question or comments?

    www.bullfrogsunscreen.com or call toll-free

    1-800-990-FROG

  • Bullfrog SPF 50 Mosquito Coast Sunscreen + Insect Repellent

    Principle Display LabelPrinciple Display LabelPrinciple Display LabelPrinciple Display Label

  • INGREDIENTS AND APPEARANCE
    BULLFROG  BROAD SPECTRUM SPF 50 SUNSCREEN
    avobenzone,octocrylene,homosalate, octinoxate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0517
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.38 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.55 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.25 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0517-4138 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product12/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/03/2021
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0517) , manufacture(58443-0517) , label(58443-0517) , analysis(58443-0517)
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