Label: LAPCOS LASTING WATERPROOF SUN- octinoxate, octisalate, zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL

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 May 4, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 5.0%, Zinc Oxide 4.8%, Titanium Dioxide 2.9%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water,Cyclopentasiloxane, PEG-10 Dimethicone, Dimethicone,Dipropylene Glycol,Portulaca Oleracea Extract,Magnesium Sulfate,Disteardimonium Hectorite,C30-45 Alkyl Cetearyl Dimethicone Crosspolymer,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Isoamyl p-Methoxycinnamate,Aluminum Hydroxide,Stearic Acid,Caffeine,Butylene Glycol,Triethoxycaprylylsilane,Disodium EDTA,Phenoxyethanol,Potassium Sorbate,Fragrance(Parfum),Iron Oxides (CI 77491),Iron Oxides (CI 77492)

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

  • DESCRIPTION

    Uses: - Helps prevent sunburn - Higher SPF gives more sun protection

    Directions: - Apply generously and as needed. - Children under 6 months of age : Ask a doctor. - Reapply as needed or after towel drying, swimming or sweating.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LAPCOS LASTING WATERPROOF SUN 
    octinoxate, octisalate, zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71379-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate2.50 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.40 g  in 50 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.45 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71379-020-021 in 1 CARTON04/01/2017
    1NDC:71379-020-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2017
    Labeler - LAP CO.,LTD (689041115)
    Registrant - LAP CO.,LTD (689041115)
    Establishment
    NameAddressID/FEIBusiness Operations
    LAP CO.,LTD689041115relabel(71379-020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(71379-020)
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