Label: 3LAB WW DAY SPF40 BROAD SPECTRUM- homosalate, octisalate, avobenzone, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Homosalate 10%

    Octisalate 5%

    Avobenzone 3.0%

    Octocrylene 2.6%

  • 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 caused by the sun
  • WARNINGS

    Warnings

    For external 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 doctorif rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    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
  • Bottle Packaging Label

    Bottle Packaging Label

  • OTHER INFORMATION

    Other information

    Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

  • Outer Packaging Label

    Outer Packaging Label

  • INGREDIENTS AND APPEARANCE
    3LAB WW DAY SPF40 BROAD SPECTRUM 
    homosalate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76159-205
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mg
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.6 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SQUALANE (UNII: GW89575KF9)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER (UNII: 965K72OQXO)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CERAMIDE 3 (UNII: 4370DF050B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ERYTHROPOIETIN (UNII: 64FS3BFH5W)  
    GOLD (UNII: 79Y1949PYO)  
    WINE GRAPE (UNII: 3GOV20705G)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
    DIACETYL BOLDINE (UNII: 37727Z7M0I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SESAME OIL (UNII: QX10HYY4QV)  
    ISODODECANE (UNII: A8289P68Y2)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    AZADIRACHTA INDICA BARK (UNII: G580B439YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    ISOMALT (UNII: S870P55O2W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76159-205-001 in 1 CARTON05/27/2016
    150 mg in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/27/2016
    Labeler - 3LAB, INC (162333277)
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