Label: BASK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 15, 2022

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  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 5%

  • 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.

    Do not use on damaged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it.

    Stop use and ask a doctor if rash occurs

    Keep out of reach of children. If product is swalowed, get medical help or contact a Poison Control Center right away.

    Flammable: Do not use near heat, flame or while smoking. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

  • Directions

    • Shake well before use • Apply liberally 15 minutes before sun exposure and rub into skin • Hold container 4 to 6 inches from the skin to apply • Do not spray directly into face. Spray on hands then apply to face • Do not apply in windy conditions • Use in a well-ventilated area

    • 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 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-sleeve shirts, pants, hats, and sunglasses

    - Children under 6 months: ask a doctor before use.

  • Inactive ingredients

    Fragrance, SD Alcohol 40-B, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer.

  • Other information

    • Protect this product from excessive heat and direct sun

    • Avoid spraying on fabrics - could cause discoloration.

  • Questions or comments?

    Call toll free 866-960-1568

  • BASK Non-Aerosol Invisible Mist Sunscreen Broad Spectrum SPF 50 Continuous Spray

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    BASK  BROAD SPECTRUM SPF 50
    avobenzone, homosalate, octisalate, octocrylene spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE25 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE83.4 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE41.7 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE41.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOBORNYL ACRYLATE (UNII: IX0PRH184P)  
    ALCOHOL (UNII: 3K9958V90M)  
    VINYL ACETATE (UNII: L9MK238N77)  
    DIBUTYL MALEATE (UNII: 4X371TMK9K)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13630-0243-4187 mL in 1 CAN; Type 0: Not a Combination Product04/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02004/14/2022
    Labeler - Prime Packaging, Inc. (805987059)
    Registrant - Prime Packaging, Inc. (805987059)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises, Inc.101946028manufacture(13630-0243) , analysis(13630-0243)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Packaging, Inc.805987059label(13630-0243) , pack(13630-0243)
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