Label: VIVIER SHEER SPF 30 MINERAL- titanium dioxide, zinc oxide lotion

  • 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)

    Octinoxate 7.5% Avobenzone 2.5%

    Ensulizole 2%

    Purpose

    Sun Protectant

  • Uses

    • Helps prevent sunburn • Sun Protection Factor 30 • 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 • 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

    Butylated Hydroxytoluene, Butylparaben, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, D-Panthenol, Ethylparaben, Hydrogenated Palm Glycerides, Methylparaben, Octyldodecanol, Octyldodecyl Neopentanoate, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water.

  • Questions?

    1 877 484 8437

  • Package Labeling:

    IP

    OPVSM

  • INGREDIENTS AND APPEARANCE
    VIVIER SHEER SPF 30 MINERAL 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYL BENZOATE (UNII: J115BRJ15H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    APPLE (UNII: B423VGH5S9)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    LEMON PEEL (UNII: 72O054U628)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2850-01 in 1 CARTON01/05/2023
    160 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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