VISAGE ENVY INVISIBLE FACE GEL SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [EMILIA COSMETICS LTD]

VISAGE ENVY INVISIBLE FACE GEL SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) GEL [EMILIA COSMETICS LTD]
PDF | XML

NDC 43219-005-50
Set ID ba131c45-8295-44c5-b780-f6c88944d4a7
Category HUMAN OTC DRUG LABEL
Packager Emilia Cosmetics Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients

    Avobenzone, 3%

    Homosalate, 15%

    Octisalate, 5%

    Octocrylene, 10%

    Oxybenzone, 4%

  • PURPOSE

    Purpose

    sunscreen

  • INDICATIONS & USAGE

    Uses  •helps prevent sunburn •if sued as directed with other sun

    protection measures (see Directions),  decreases the risk of skin

    cancer and early 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 isohexadecane, dimethicone bis-isobutyl

    PEG-20 crosspolymer, cyclopentasiloxane, phenoxyethanol, fragrance,

    tocopheryl acetate (vitamin E), plukenetia volubis seed oil tocopherol,

    bisabolol, astaxanthin

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VISAGE ENVY INVISIBLE FACE GEL SPF50 
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.54 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.51 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.02 g  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2.01 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43219-005-501 in 1 BOX05/05/2018
    150 mL in 1 TUBE; 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(43219-005)

Related Drugs