Label: ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30- homosalate, octisalate, avobenzone, and octocrylene lotion

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

Drug Label Information

Updated November 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • Active ingredients

    Homosalate 10% Octocrylene 10% Octisalate 5% Avobenzone 3%


  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see decreases the risk of skin cancer and early skin aging caused by the sun ), Directions
  • Warnings

    For external use only

    on damaged or broken skin Do not use

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

    if rash occurs Stop use and ask a doctor

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

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every 2 hours.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats, and sunglasses.
    • children under 6 months: Ask a doctor
  • Inactive ingredients:

    Water/Eau, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclopentasiloxane, Microcrystalline Wax, Cetyl Dimethicone, Cyclohexasiloxane, Panthenol, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Beta-Glucan, Retinyl Palmitate, Vitis Vinifera (Grape) Seed Extract, Superoxide Dismutase, Glycerin, Hydrogenated Castor Oil, Ethylhexylglycerin, Phenyl Trimethicone, Caprylyl Glycol, Polyglyceryl-4 Isostearate, Hexyl Laurate, Sodium Chloride, Silica, Disodium EDTA, Phenoxyethanol














  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    925.734.3638

  • PRINCIPAL DISPLAY PANEL CARTON

    WATER RESISTANT

    PARABEN FREE

    4 fl. oz. 118 mL

                  All Skin Types Multipatented formula provides broad-spectrum SPF 30 protection from sun’s harmful rays to help reduce the risk of skin damage. Regular use of this product may help minimize visible lines, uneven coloration, dryness, and dullness associated with sun exposure. Triple patented Vital Repair+ Complex® helps disarm free radicals, which can create prematurely older-looking skin. Quickly absorbed lotion locks in moisture without leaving a sticky finish. Ideal for sensitive skin.













    • Contains triple patented Vital Repair+ Complex® • Water resistant (80 minutes) • Designed not to clog pores • 100% fragrance and paraben free • Allergy tested • Clinically formulated • Dermatologist tested • Patented sensitive-skin formula • Not tested on animals










    Dist. by/par Shaklee Corporation 4747 Willow Road Pleasanton, CA 94588 USA Item #32565 Imp. by/par Shaklee Canada Inc. 3100 Harvester Road, Unit 7 Burlington, ON L7N 3W8





    CARTON

  • PRINCIPAL DISPLAY PANEL TUBE

    Broad-spectrum SPF 30 protection helps shield skin from sun’s harmful rays. 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.


    Directions: Apply generously 15 minutes before sun exposure.

    TUBE

  • INGREDIENTS AND APPEARANCE
    ENFUSELLE BODY SUNSCREEN BROAD SPECTRUM SPF 30 
    homosalate, octisalate, avobenzone, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59899-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    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) OCTOCRYLENE100 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59899-007-011 in 1 CARTON11/11/2013
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/11/2013
    Labeler - Shaklee Corporation (129469263)
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