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Sei Bella (Melaleuca, Inc.)

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CREAM 1 JAR in 1 BOX (54473-186-02) > 50 mL in 1 JAR Label Information

Complete Sei Bella Information

  • ACTIVE INGREDIENT

    Active ingredients
    Avobenzone 1.8%, Homosalate 6%, Octisalate, 3%, Octocrylene 1.86%, Oxybenzone 1.8%


  • PURPOSE

    Purpose
    Sunscreen


  • INDICATIONS & USAGE

    Use

    • provides moderate protection against sunburn

  • WARNINGS

    Warnings
    For external use only


  • 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 or irritation develops and lasts


  • KEEP OUT OF REACH OF CHILDREN

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


  • DOSAGE & ADMINISTRATION

    Directions

    • apply smoothly on cleansed skin before sun exposure and as needed
    • children under six months of age: ask a doctor

  • CLINICAL STUDIES

    Other information
    • dermatologist and allergy tested

  • GENERAL PRECAUTIONS

    Other information

    • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
    • may stain some fabrics

  • STORAGE AND HANDLING

    Other information

    • do not store at temperatures below 32°F (0°C) or above 120°F (49°C)

  • INACTIVE INGREDIENT

    Inactive ingredients
    aqua (water/eau), polyacrylate-15, polyacrylate-17, glycerin, cetyl palmitate, C20-22 alkyl phosphate, C20-22 alcohols, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, caprylic/capric triglycerides, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, xanthan gum, triethanolamine, sodium polyacrylate, potassium sorbate, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, camellia oleifera leaf extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, ginkgo biloba leaf extract, butylene glycol, allantoin, tocopheryl acetate, linalool, hexyl cinnamal, benzyl salicylate, alpha isomethyl ionone


  • INGREDIENTS AND APPEARANCE
    SEI BELLA  DAYTIME DELIVERY
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-186
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.9 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 3 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.5 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.93 g  in 50 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.9 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Trolamine (UNII: 9O3K93S3TK)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GINKGO (UNII: 19FUJ2C58T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54473-186-02 1 in 1 BOX
    1 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 05/01/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    Name Address ID/FEI Business Operations
    Melaleuca, Inc. 139760102 manufacture