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

  • 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 February 19, 2021

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  • Product Facts

  • Medicinal ingredients

    10% Titanium Dioxide

    8% Zinc Oxide

    Purpose

    Sunscreen

  • Uses

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

  • Warnings

    For external use only.

    Do not use

    on damaged or 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.

    Other warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center 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 increase 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: - limits 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).

  • Non-medicinal ingredients

    Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone, Butylparaben, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Cetyl Dimethicone, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dipropylene Glycol Dibenzoate, DL-alpha Tocopheryl Acetate, Ethylparaben, Glycerin, Glyceryl Stearate, Green Tea Extract, Iron Oxides CI 77491, Iron Oxides CI 77492, Iron Oxides CI 77499, Isopropyl Titanium Triisostearate, Methylparaben, Phenoxyethanol, Phytic Acid, Polyhydroxystearic Acid, Polysorbate 20, PPG-15 Stearyl Ether Benzoate, Propylene Glycol, Propylparaben, Pyrus Malus (Apple) Fruit Extract, Saccharum Officinarum (Sugar Cane) Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, t-Butyl Alcohol, Triethoxycaprylylsilane, VP/Eicosene Copolymer, Water/Eau, Xanthan Gum.

  • Questions?

    Call 1 877 484 8437

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    SHEET SPF 30 MINERAL 
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2232
    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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    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)  
    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)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    APPLE (UNII: B423VGH5S9)  
    SUGARCANE (UNII: 81H2R5AOH3)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2232-61 in 1 BOX01/04/2021
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/04/2021
    Labeler - Vivier Pharma Inc. (250996550)
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