Label: LEG BODY MAKEUP- octisalate, octocrylene cream

  • NDC Code(s): 68577-111-01
  • Packager: COSMAX USA, CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Octisalate 3.2%

    Octocrylene 6.2%

  • 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

    For sunscreen use:

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a 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
  • OTHER INFORMATION

    Other information

    • protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENT

    Inactive ingredientsWater,Cyclopentasiloxane,Isododecane,Isononyl Isononanoate,Glycerin,Cetyl PEF/PPG-10/1 Dimethicone, Dimethicone, Magnesium Sulfate,Polyglyceryl-4 Isostearate, Dimethicone/PEG-10/15 Crosspolymer,Disodium Stearoyl Glutamate,Disteardimonium Hectorite, Phenoxyethanol, Polybutene, Methylparaben, Alcohol Denat, Chlorphenesin, Acrylonitrile/methyl methacrylate/vinylidene chloride, Copolymer, Butylparaben, Aluminum Hydroxide, Sodium Hyaluronate, Isobutane,Dipropylene Glycol, Sodium Citrate, Tocopherol, Pentaerythrityl tetra-di-butyl hydroxyhydrocinnamate; may contain, Titanium Dioxide,Iron Oxides.

  • QUESTIONS or COMMENTS

    Questions or comments?

    1-8771-877-900-6700 Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    Primary Package(Inner) Primary Package

  • PRINCIPAL DISPLAY PANEL

    Outer PackageOuter Package (Secondary)

  • PRINCIPAL DISPLAY PANEL

    shade Label

    Shade

  • INGREDIENTS AND APPEARANCE
    LEG BODY MAKEUP 
    octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68577-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.2 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ISOBUTANE (UNII: BXR49TP611)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ISODODECANE (UNII: A8289P68Y2)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68577-111-011 in 1 CARTON06/01/2023
    1100 mg in 1 TUBE; 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(68577-111)
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