Label: SEI BELLA DAYTIME DELIVERY- avobenzone, homosalate, octisalate, ocrylene and oxybenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated February 3, 2011

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  • 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
    Foe 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 or age: ask a doctor
  • 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
  • CLINICAL STUDIES

    Other information

    • dermatologist and allergy tested
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients
    aqua (water/eau), polyacrylate-15, polyacrylate-17, C20-22 phosphate, C20-22 alcohols, trisiloxane, dimethicone, cyclopentasiloxane, dimethicone crosspolymer, cetyl palmitate, glycerin, butyrospermum parkii (shea butter), C12-15 alkyl benzoate, dicaprylyl carbonate, C14-22 alcohols, C12-20 alkyl glucoside, propylheptyl caprylate, acetyl tetrapeptide-9, phenoxyethanol, cetyl alcohol, caprylyl glycol, 1,2 hexanediol, triethanolamine, xanthan gum, trisodium ethylenediamine disuccinate, parfum, bisabolol, panax ginseng root extract, lycium barbarum fruit extract, aloe barbadensis leaf juice, camellia oleifera leaf extract, butylene glycol, allantoin, tocopheryl acetate, limonene, butylphenyl methylpropional

  • PRINCIPAL DISPLAY PANEL

    image of box

  • INGREDIENTS AND APPEARANCE
    SEI BELLA  DAYTIME DELIVERY
    avobenzone, homosalate, octisalate, ocrylene and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-187
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9018 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.006 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.503 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.9319 g  in 50 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.9018 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    Glycerin (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Trolamine (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-187-021 in 1 BOX
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2010
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.139760102manufacture
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