Label: SOLAR PROTECTION FORMULA SPF 58 SUNSCREEN- titanium dioxide, zinc oxide 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 December 7, 2012

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • Active Ingredients:

    Titanium Dioxide 10%

    Zinc Oxide 3%

  • Purpose

    Sunscreen

    Sunscreen

  • Uses:

    Helps prevent sunburn. 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 damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    When using this product, keep out of eyes. Rinse with water to remove.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Reapply:
      • After 40 minutes of swimming or sweating
      • Immediately after towel drying
      • At least every 2 hours
    • Children under 6 months: Ask a doctor
    • 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 10:00 a.m.-2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other Information:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
  • Inactive Ingredients:

    Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Carton Label

    NDC 58892-911-88

    SOLAR
    PROTECTION
    FORMULA®

    Gentle Mineral
    Sunscreen

    SPF 58
    Broad Spectrum
    Water Resistent
    (40 minutes)

    Net Wt. 2.5 Oz./ 70g

    Principal Display Panel – Carton Label
  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA SPF 58   SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-911
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide100 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Butylparaben (UNII: 3QPI1U3FV8)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cyclomethicone (UNII: NMQ347994Z)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Isobutylparaben (UNII: 0QQJ25X58G)  
    Isopropylparaben (UNII: A6EOX47QK0)  
    Lemon Balm Oil (UNII: MJ76269K9S)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    Polyoxyl 100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
    Talc (UNII: 7SEV7J4R1U)  
    Alpha-Tocopherol (UNII: H4N855PNZ1)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58892-911-881 in 1 CARTON
    170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/02/2004
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(58892-911)
    Establishment
    NameAddressID/FEIBusiness Operations
    Process Technologies & Packaging809172885MANUFACTURE(58892-911) , PACK(58892-911)
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