Label: SOLAR PROTECTION FORMULA SPF 58  SUNSCREEN - titanium dioxide and zinc oxide cream 

  • Label RSS
  • NDC Code(s): 58892-911-88
  • Packager: Fallien Cosmeceuticals, LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

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  • Active Ingredients:

    Titanium Dioxide 10%

    Zinc Oxide 3%

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  • Purpose

    Sunscreen

    Sunscreen

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  • 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.

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  • 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.

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  • 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.
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  • Other Information:

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    SOLAR PROTECTION FORMULA SPF 58   SUNSCREEN
    titanium dioxide, zinc oxide cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58892-911
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 100 mg  in 1 g
    Zinc Oxide (Zinc Oxide) Zinc Oxide 30 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Butylene Glycol  
    Butylparaben  
    Medium-Chain Triglycerides  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)  
    Cetostearyl Alcohol  
    Cyclomethicone  
    Dimethicone  
    Edetate Disodium  
    Glyceryl Monostearate  
    Ferric Oxide Yellow  
    FERROSOFERRIC OXIDE  
    Isobutylparaben  
    Isopropylparaben  
    Lemon Balm Oil  
    OCTYLDODECYL NEOPENTANOATE  
    Polyoxyl 100 Stearate  
    Phenoxyethanol  
    Vitamin A Palmitate  
    Sorbitan Monolaurate  
    Talc  
    Alpha-Tocopherol  
    .Alpha.-Tocopherol Acetate  
    Water  
    Xanthan Gum  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58892-911-88 1 in 1 CARTON
    1 70 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 01/02/2004
    Labeler - Fallien Cosmeceuticals, LTD. (958388357)
    Establishment
    Name Address ID/FEI Business Operations
    Custom Analytics LLC 144949372 ANALYSIS(58892-911)
    Establishment
    Name Address ID/FEI Business Operations
    Process Technologies & Packaging 809172885 MANUFACTURE(58892-911), PACK(58892-911)
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