Label: ANHYDROUS SPF 30- titanium dioxide, zinc oxide cream

  • NDC Code(s): 59958-200-03
  • Packager: Owen Biosciences, Inc.
  • 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 22, 2022

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  • Drug Facts

    Active ingredients                  Purpose

    Titanium Dioxide 10.20%        Sunscreen

    Zinc Oxide 3.70%                  Sunscreen

  • PURPOSE

    USES

    Helps Prevent sunburn.

    Higher SPF gives more sunburn protection

    Provides moderate protection against sunburn.

  • WARNINGS

    Warnings

    For external use only. When using this product

    keep out of eyes.  Rinse with water to remove.

    Stop use and ask doctor if rash and irritation

    develops and lasts.  Keep out of reach of

    children. If swallowed, get medical help or

    contact poison control center right away.

  • INDICATIONS & USAGE

    Directions

    Apply evenly before sun exposure and as

    needed.  For children under 6 months of age: ask

    a doctor.  Reapply as needed or after towel

    drying, swimming or perspiring.

  • INFORMATION FOR PATIENTS

    Other Information

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other

    harmful effects of the sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer,

    Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol,

    Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.

  • PRINCIPAL DISPLAY PANEL

    main label

  • INGREDIENTS AND APPEARANCE
    ANHYDROUS SPF 30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE10.2 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z) 17.5 g  in 100 g
    TRIBEHENIN (UNII: 8OC9U7TQZ0) 1 g  in 100 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) 0.09 g  in 100 g
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.25 g  in 100 g
    FERROSOFERRIC OXIDE (UNII: XM0M87F357) 0.01 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-200-0330 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2011
    Labeler - Owen Biosciences, Inc. (790003045)
    Registrant - Owen Biosciences, Inc. (790003045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Owen Biosciences, Inc.790003045manufacture(59958-200)
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