Label: PHYSICAL FACIAL BLOCK SPF 30- zinc oxide, titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 10, 2014

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  • WARNINGS For external use only

    When using this product:Keep out of eyes. Rinse with water to remove.
    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.

  • Active Ingredients

    10% Titanium Dioxide  
    8% Zinc Oxide

    Purpose

    Sunscreen

    Sunscreen

  • Uses

    Helps prevent sunburn. ■ Provides broadspectrum
    UVA/UVB protection. ■ Ideal for daily
    use; can be applied under makeup. ■ Optimal
    for post-care or on sensitive skin.

    Directions

    Apply daily to face, neck and chest. ■ Apply
    liberally 15-30 minutes before sun exposure and
    as needed. ■ Reapply after towel drying,
    swimming or sweating. ■ For children under
    six months of age, consult a physician.

  • Inactive Ingredients

    Alumina, Ammonium Acryloyldimethyltaurate,
    Bis-PEG/PPG-16/16 PEG/PPG16/16
    Dimethicone, Butylparaben, Camellia Sinensis
    (Green Tea) Extract, Caprylic/Capric Triglyceride,
    Ceteareth 20, Cetearyl Alcohol, Cetyl Dimethicone,
    Citrus Medica Limonum (Lemon
    Bioflavanoids) Peel Extract, Cyclomethicone,
    C12-15 Alkyl Benzoate, Dimethicone,
    Dipropylene Glycol Dibenzoate, Eicosene
    Copolymer, Ethylparaben, Glycerin, Glyceryl
    Stearate, Isopropyl Titanium Triisostearate
    /Triethoxycaprylyl Crosspolymer, 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, Water/Eau, Xanthan Gum.

  • Principal Display Panel

    Physical Facial Block SPF 30 US Carton 07-6046-04

    Physical Facial Block SPF 30 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    PHYSICAL FACIAL BLOCK  SPF 30
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.8 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    APPLE (UNII: B423VGH5S9)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE (UNII: 55A74AJ3KB)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2330-61 in 1 BOX
    160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/28/2006
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivier Pharma, Inc.250996550manufacture(67226-2330)
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