TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [VIVIER PHARMA INC]

TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [VIVIER PHARMA INC]
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NDC 67226-2231-6
Set ID 1c2425da-b35a-460e-8fef-675e367ce615
Category HUMAN OTC DRUG LABEL
Packager Vivier Pharma Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • DRUG FACTS

  • ACTIVE INGREDIENTS

    Titanium Dioxide 10.0%
    Zinc Oxide 8.0%

    PURPOSE

    Sunscreen

  • USES

    • Helps prevent sunburn and provides a sun protection factor of 30.
    • Ideal for daily use; can be applied under makeup.
  • WARNINGS

    For external use only

    • The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and
      regular use of sunscreens over the years may reduce the chance of these harmful effects.​

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
    • Do not use on damaged or broken skin.

    Stop use and ask a doctor if

    • Rash or irritation develops and lasts.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply daily to face, neck and chest.
    • Apply liberally and evenly 15 minutes before sun exposure.
    • Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
    • For use on children less than 6 months of age, consult a healthcare practitioner.
    • Use a water resistant sunscreen if swimming or sweating.
  • INACTIVE INGREDIENTS:

    ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS PEG/PPG-16-16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, C12-15 ALKYL
    BENZOATE, CAMELIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/- CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL
    DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE, METHYLPARABEN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYSORBATE 20, PPG-15 STEARYL ETHER BENZOATE, PROPYLPARABEN, PYRUS MALUS (APPLE) FRUIT EXTRACT, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU, XANTHAN GUM.

  • Questions?

    450 455 9779 1 877 484 8437

  • Package Labeling:

    outerupdated 60mL inner packaging

  • INGREDIENTS AND APPEARANCE
    TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LEMON PEEL (UNII: 72O054U628)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    APPLE (UNII: B423VGH5S9)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2231-61 in 1 CARTON11/11/2017
    160 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/11/2017
    Labeler - Vivier Pharma Inc (250996550)

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