3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]

3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]
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NDC 76159-345-01, 76159-345-02
Set ID 2bee6b87-c889-4ea1-87ad-e28949bcb67a
Category HUMAN OTC DRUG LABEL
Packager 3LAB, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Homosalate 10.0% Octisalate 5.0% Avobenzone 3.0% Octocrylene 2.6%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

    If used ad directed with other sun protection measures (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply liberally 15 minutes before sun exposure

    Use a water resistant sunscreen if swimming or sweating

    Reapply at least every 2 hours

    Children under 6 months: Ask a doctor

    Apply to all skin exposed to the sun

  • Other Information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Water (Aqua/Eau), Dipropylene Glycol, Caprylyl Methicone, Dicaprylyl Carbonate, PEG/ PPG-17/6 Copolymer, Potassium Cetyl Phosphate, Methyl Glucose Sesquistearate, Hydrogenated Palm Glycerides, Polyacrylate-15, Polyacrylate-17, Alcohol, Butylene Glycol, Adenosine, Euterpa Oleracea (Acai) Fruit Extract, Portulaca Oleracea Extract, Morus Alba (Mulberry) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Dipotassium Glycyrrhizate, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 80, Panthenol, Cetyl Alcohol, Caprylyl Glycol, Tocopheryl Acetate, PEG-10 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Potassium Hydroxide, Disodium EDTA

  • DESCRIPTION

    This ultimate sun protection cream was created for those who desire a maximum defense against UVA and UVB rays while fighting free radical damage. Using a unique, lightweight formula with special polymer technology, this sunblock helps to prevent sun damage without feeling heavy on the skin. The powerful antioxidants, green tea and acai berry, work to combat the signs of premature aging, such as sun spots and wrinkles, while Vitamin E soothes and hydrates sun exposed skin. 

  • PRINCIPAL DISPLAY PANEL


    InnerLabel

    OuterLabel

  • INGREDIENTS AND APPEARANCE
    3LAB PERFECT SUNSCREEN SPF 50 PLUS BROAD SPECTRUM 
    homosalate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-345
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ADENOSINE (UNII: K72T3FS567)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76159-345-0160 mL in 1 TUBE; Type 0: Not a Combination Product12/19/2017
    2NDC:76159-345-0210 mL in 1 TUBE; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/21/2011
    Labeler - 3LAB, Inc (162333277)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(76159-345)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(76159-345)

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