Label: KOPARI ANTIOXIDANT FACE SHIELD MINERAL SPF 30- zinc oxide lotion

  • NDC Code(s): 68577-154-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 24, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Zinc Oxide 14.4%

  • 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

    • Shake well. Apply 3 pumps and smooth on to the face and neck as the last step of your skicare routine in the morning.

    • Apply generously and evenly 15 minutes before sun exposure
      • Reapply at least every 2 hours.
      • Use water resistant sunscreen if swimming or sweating
      • 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: water/aqua/eau,propanediol,c12-15 alkyl benzoate,glycerin,lsoamyl laurate,butyloctyl salicylate,styrene/acrylates copolymer,pentylene glycol,cetearyl alcohol,polysorbate 60,potassium cetyl phosphate,sodium hyaluronate,rubus ldaeus (raspberry) seed oil,glycine soja (soybean) oil,oryza sativa (rice) extract, oryza sativa (rice) germ extract, panax ginseng root extract,argania spinosa kernel oil,bisabololzea mays (corn) oil,1,2-hexanediol,butylene glycol,caprylyl glycol,sodium acrylate/sodium acryloyldimethyl taurate copolymer,lsohexadecanepolyhydroxystearic acid,sodium citrate,triethoxycaprylylsilane,polyglyceryl-3 diisostearate,sorbitan oleate,citric acid,tocopheryl acetate,ethyl hexanediol,polysorbate 80,cholecalciferol

  • OTHER INFORMATION

    Other information

    Shake well. 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

    Primary Packaging

    Primary Package

  • PRINCIPAL DISPLAY PANEL

    Secondary Package

    Outer Carton

  • INGREDIENTS AND APPEARANCE
    KOPARI ANTIOXIDANT FACE SHIELD MINERAL SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CORN OIL (UNII: 8470G57WFM)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ETHOHEXADIOL (UNII: M9JGK7U88V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-154-011 in 1 CARTON06/01/2023
    145 mg in 1 BOTTLE, PUMP; 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(68577-154)