Label: LAPOTHICELL SUNSCREEN- avobenzone, bemotrizinol, ethylhexyl triazone, homosalate, octisalate, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2020

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

  • ACTIVE INGREDIENT

    Avobenzone, Bemotrizinol, Ethylhexyl Triazone, Homosalate, Octisalate, Octocrylene

  • PURPOSE

    Helps prevent sunburn.

    Higher SPF gives more sunburn protection.

  • DOSAGE & ADMINISTRATION

    For topical use only

  • 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.

    Stop use and ask a doctor if 

    *rash or irritation develops and lasts

    Keep our of reach of children.

    If product is swallowed, get medical help or contact Poison Control Center

    *Please read the "Directions", "Warnings", and "Other Information" carefully before use

  • Keep out of reach of children.

    If product is swallowed, get medical

    Help or contact a poison Control Center right away.

  • INDICATIONS & USAGE

    Apply liberally and evenly to all exposed areas before sun exposure and as needed

    Children under 6 months of age: ask a doctor

  • INACTIVE INGREDIENT

    Water, Propanediol, Alcohol, Coco-Caprylate/Caprate, Pentylene Glycol, Dimethicone, Silica, Methyl Methacrylate Crosspolymer, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Pullulan, Laureth-7, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Isohexadecane, Tromethamine, Caprylyl Glycol, Allantoin, Tocopheryl Acetate, Polysorbate 80, Ethylhexylglycerin, Disodium EDTA, Sorbitan Oleate, Xanthan Gum, Hydrolyzed Hyaluronic Acid, Butylene Glycol, Glycerin, Psidium Guajava Leaf Extract, Camellia Sinensis Leaf Extract, Punica Granatum Fruit Extract, Ficus Carica (Fig) Fruit Extract, Rosa Centifolia Flower Extract, Codonopsis Lanceolata Root Extract, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Fragrance, Limonene, Linalool, Butylphenyl Methylpropional

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    LAPOTHICELL SUNSCREEN 
    avobenzone, bemotrizinol, ethylhexyl triazone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58832-0005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
    BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL1.75 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.75 g  in 50 mL
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4) (ETHYLHEXYL TRIAZONE - UNII:XQN8R9SAK4) ETHYLHEXYL TRIAZONE1 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58832-0005-22 in 1 CARTON08/25/2020
    1NDC:58832-0005-150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/20/2020
    Labeler - EYESOME. Co.,Ltd. (557795360)
    Registrant - EYESOME. Co.,Ltd. (557795360)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(58832-0005)