VISAGE ENVY FACIAL MOISTURIZING SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EMILIA COSMETICS LTD]

VISAGE ENVY FACIAL MOISTURIZING SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [EMILIA COSMETICS LTD]
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NDC 43219-018-30
Set ID eb525b0b-522c-45ad-a062-c213b38555ee
Category HUMAN OTC DRUG LABEL
Packager Emilia Cosmetics Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone, 2.1%

    Homosalate, 4.0%

    Octisalate, 4.0%

    Octocrylene, 2.0%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    Uses  •helps prevent sunburn  •if used as directed

    with other sun protection measures (see Directions),

    decreases the risk of skin cancer and other skin    aging

    caused by the sun.

  • WARNINGS

    Warnings

    For external use only.

    Do not use on  •damaged or broken skin

    When using this product  •keep out of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor  •if rash occurs

  • 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 liberally 15 minutes before sun exposure •reapply at least every

    2 hours •use water resistant sunscreen if swimming or sweating •children

    under 6 months of age: ask a doctor.

    Sun Protection Measures: Spending time in the sun increases your

    risk of skin cancer and early skin aging. To decrease this risk, regularly

    use a sunscreen with a Broad Spectrum SPF value of 15 or higher and

    other sun prtection measures including:

    •limit time in the sun, especially from 10 am. - 2 p.m.

    •wear long-sleeved shirts, pants, hats and sunglasses

  • STORAGE AND HANDLING

    Other information •protect the product in this container

    from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredients Water, Dimethicone, Trisiloxanane, Isononyl Isononanoate, Cetyl Alcohol,

    Glycerin, Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

    PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Dimethicone Crosspolymer, Xanthan Gum,

    Tocopheryl Acetate (Vitamin E), Polysorbate 20,

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Disodium EDTA, Sodium Hydroxide, BHT, Hyaluronic Acid

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VISAGE ENVY FACIAL MOISTURIZING SPF30 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.86 g  in 236.59 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.55 g  in 236.59 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.55 g  in 236.59 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.77 g  in 236.59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-21 (UNII: 53J3F32P58)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-018-301 in 1 BOX05/05/2018
    188 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/05/2018
    Labeler - Emilia Cosmetics Ltd (600076624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Emilia Cosmetics Ltd600076624manufacture(43219-018)

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