Label: BULL FROG SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2023

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

  • Active Ingredient

    Avobenzone 3%
    Homosalate 15%
    Octisalate 5%
    Octocrylene 10%

  • 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

    • Reapply:

    • 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 value 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 of age: Ask a doctor.

  • Other information

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

    Acacia Famesiana extract, acrylate/octyl acrylamide copolymer, aloe barbadensis leaf extract, C13-15 alkanes, camellia sinensis (green tea) leaf extract, chamomile recutita (matricaria) flower extract, cyclohexasiloxane, ethylhexyl palmitate, fragrance, glycerin, hydroxypropycellulose, isopropyl myrsitate, lavandula angustifolia (lavender) flower extract, phenethyl benzoate, PPG-12/SDMI copolymer, propylene glycol, rosmarinus officinalis (rosemary) extract, SD alcohol 40-B, tocopheryl acetate.

  • Label

    BF52114EF

  • INGREDIENTS AND APPEARANCE
    BULL FROG SPF 50 
    avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77714-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    VACHELLIA FARNESIANA FLOWER (UNII: 8487B3MG6D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    PHENETHYL BENZOATE (UNII: 0C143929GK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    ROSEMARY (UNII: IJ67X351P9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77714-002-48148 mL in 1 BOTTLE; Type 0: Not a Combination Product08/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/08/2021
    Labeler - Bullfrog Brands, LLC (117426500)