Label: BULLFROG SPF 50 SUNSCREEN INSECT REPELLENT- avobenzone, homosalate, octisalate, and octinoxate 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 18, 2022

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active Ingredients

    Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, and Octixonate 7.5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    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

    Do not useon damaged or broken skin.

    When using this product: Keep away from face to avoid breathing in • Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

  • SPL UNCLASSIFIED SECTION

    Flammable

    • do not use near heat,flame or while smoking
    • avoid long-term storage above 104ºF (40ºC)
    • do not puncture or incinerate
    • contents under pressure
    • do not store at temperatures above 120ºF (49ºC). 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
    • reapply:
    • after 80 minutes of swimming and sweating
    • immediately after towel drying
    • at least every 2 hours.
    • children under 6 months: Ask a doctor.
  • Other information

    • Protect this product 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,

  • Question or comments?

    www/bullfrogsunscreen.com or call toll-free 1-800-990-FROG

  • Bullfrog SPF 50 Sunscreen + Insect Repellent

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    BULLFROG  SPF 50 SUNSCREEN INSECT REPELLENT
    avobenzone, homosalate, octisalate, and octinoxate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0215
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE66.38 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.55 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE88.5 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE44.25 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE44.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Product Characteristics
    Coloryellow (Very Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0215-4176 mL in 1 CAN; 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 Packaging Inc. (805987059)
    Registrant - Prime Packaging Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises Inc101946028manufacture(13630-0215) , analysis(13630-0215)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging Inc.805987059pack(13630-0215) , label(13630-0215)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!