EXTREME SPORT SPF 70 (AVOBENZONE - 3.00% HOMOSALATE - 15.00% OCTISALATE - 5.00% OCTOCRYLENE - 4.00% OXYBENZONE - 6.00%) SPRAY [TOP CARE]

EXTREME SPORT SPF 70 (AVOBENZONE - 3.00% HOMOSALATE - 15.00% OCTISALATE - 5.00% OCTOCRYLENE - 4.00% OXYBENZONE - 6.00%) SPRAY [TOP CARE]
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NDC 36800-727-04
Set ID deffcf4e-30ab-4bfd-bf90-403ffdb04971
Category HUMAN OTC DRUG LABEL
Packager Top Care
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients                  Purpose

    Avobenzone - 3.00%               Sunscreen
    Homosalate - 15.00%              Sunscreen
    Octisalate - 5.00%                   Sunscreen
    Octocrylene - 4.00%                Sunscreen
    Oxybenzone - 6.00%               Sunscreen

  • PURPOSE

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn

  • WarningsFor external use only

    Flammable: Do not use near heat, flame, or while smoking

    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. Do not puncture or incinerate. Contents under pressure. Do not store at temperature 120F

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    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 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

  • Inactive ingredients

    Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Artemia Extract, Ascorbyl Palmitate, Butyloctyl Salicylate, Cyclopentasiloxane, Fragrance, Glycerin, Polyester-8, Retinyl Palmitate, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    EXTREME SPORT SPF 70 
    avobenzone - 3.00% homosalate - 15.00% octisalate - 5.00% octocrylene - 4.00% oxybenzone - 6.00% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-727
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 g
    Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    BRINE SHRIMP (UNII: 3ID50N77DH)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-727-04141 g in 1 CAN; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2013
    Labeler - Top Care (006935977)
    Registrant - Product Manufacturer Mfg. (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Manufacturer Mfg.927768135manufacture(36800-727) , label(36800-727)

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