Label: VIVIER SHEER SPF 45- zinc oxide, octocrylene, octinoxate, octisalate lotion

  • NDC Code(s): 67226-2852-0, 67226-2852-1
  • Packager: Vivier Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

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  • Drug Facts

  • Active ingredients (w/w)

    Zinc Oxide 9.9% Octocrylene 8% Octinoxate 7.5% Octisalate 5%


    Purpose

    Sun Protectant

  • Uses

    • Helps prevent sunburn • Sun Protection Factor 45 • 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

  • Warnings

    For external use only.

    Do not use

    on broken skin.

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    rash occurs.

    Keep out of reach of children.

    If swallowed, call a poison control centre or get medical help right away.

  • Directions

    Adults and children over 6 months of age: • Apply liberally and evenly 15 minutes before sun exposure • Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating. • 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 protection measures including: • limit time in the sun, especially from 10 a.m.– 2 p.m.; and • wear long-sleeved shirts, pants, hats, and sunglasses.

  • Other information

    Store at room temperature (15-30°C / 59-86°F).

  • Inactive ingredients

    Behenyl Alcohol, Butylparaben, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Ceteareth-20, Cetearyl Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylparaben, Methylparaben, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, Silica, Tetrasodium EDTA, Tocopherol,  Triethoxycaprylylsilane, Water.

  • Questions?

    1 877 484 8437

  • Package Labeling:90ml

    Outer Package3Inner Package3

  • Package Labeling:250ml

    Outer Package4Inner Package4

  • INGREDIENTS AND APPEARANCE
    VIVIER SHEER SPF 45 
    zinc oxide, octocrylene, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2852
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION99 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2852-01 in 1 CARTON01/05/2023
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:67226-2852-11 in 1 CARTON01/05/2023
    2250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/05/2023
    Labeler - Vivier Pharma, Inc. (250996550)
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