Label: KOPARI SUN SHIELD SOFT GLOW DAILY FACE SPF30- octisalate, octocrylene, avobenzone, homosalate spray

  • NDC Code(s): 68577-153-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 10%

    Octisalate 5%

    Octocrylene 4%

    Avobenzone 3%

  • PURPOSE

    Purpose

    Sunscreen

  • USES

    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 cause by the sun
  • Warnings

    Warnings

    For extenal use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor ifrash occurs

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

  • DIRECTIONS

    Directions

    • Apply generously and evenly 15 minutes before sun exposure
      • Reapply At least every 40 minutes
      • 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. - 2p.m.

    -wear long-sleeved shirts, pants, hats and sunglasses

    Children under 6 months of age: Ask a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients:Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Titanium Dioxide (Cl 77891), Tocopheryl Acetate, Silica, Tin Oxide, Tocopherol.

  • OTHER INFORMATION

    Other information

    • Protect the product in this container from excessive heat and direct sun
  • QUESTIONS or COMMENTS

    Questions or comments?

    Call (858) 252 0099

  • PRINCIPAL DISPLAY PANEL

    Packaging

    Display

  • INGREDIENTS AND APPEARANCE
    KOPARI SUN SHIELD SOFT GLOW DAILY FACE SPF30 
    octisalate, octocrylene, avobenzone, homosalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-153
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STANNOUS OXIDE (UNII: JB2MV9I3LS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-153-011 in 1 CARTON06/01/2023
    1100 mg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2023
    Labeler - COSMAX USA, CORPORATION (010990210)
    Registrant - COSMAX USA, CORPORATION (010990210)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSMAX USA. CORPORATION010990210manufacture(68577-153)
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