Label: BULL FROG- avobenzone, octocrylene, homosalate, octyl methoxycinnamate, octisalate spray

  • NDC Code(s): 58443-0575-4
  • Packager: Prime Enterprises Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 3, 2024

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  • Active ingredients

    Avobenzone 3%

    Octocrylene 5%

    Homosalate 10%

    Octyl Methoxycinnamate 7.5%

    Octisalate 5%

  • Purpose

    Sunscreens

  • Use:

    • Helps prevent sunburn
  • 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.

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

    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 ingredients:

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

  • Questions 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 Label

  • INGREDIENTS AND APPEARANCE
    BULL FROG 
    avobenzone, octocrylene, homosalate, octyl methoxycinnamate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.4 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
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYL BUTYLACETYLAMINOPROPIONATE (UNII: 65GQA237EH)  
    ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)  
    Product Characteristics
    Coloryellow (Very Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0575-4138 mL in 1 TUBE; Type 0: Not a Combination Product12/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/03/2021
    Labeler - Prime Enterprises Inc. (101946028)
    Registrant - Prime Enterprises Inc. (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc.101946028pack(58443-0575) , manufacture(58443-0575) , label(58443-0575) , analysis(58443-0575)
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