Label: MINERAL SUNSCREEN SPF 50- zinc oxide titanium dioxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 March 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Zinc Oxide 24%Sunscreen
    Titanium Dioxide 22.5%Sunscreen
  • Uses

    • Helps prevent sunburnIf 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.

    When using this product keep out of eyes.

    Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keeo out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply atleast every 2 hours
    • Sun Protection Measures

    Spending time in the sun increases your risk of skin can cer and early skin aging. To decrease this risk, regularly use a sunscreen with a broa spectrum SPF of 15 or higher & other sunscreen measures including:

    • Limit time in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeve shirts, pants, hats, & sunglasses
    • Children under 6 months of age: Ask a doctor.
  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Mica, Silica, Caprrylic/Capric Triglyceride, Lauroyl Lusine, Potassium Sorbate, Sodium Benzoate, Undecylenoyl Glycine, Capryloyl Glyccine. Camellia Sinensis Polyphenols, Caffeine, Resveratrol, Tocpheryl Acetatte, Carthamus Tinctorius (Safflower) Seed Oil, Cam llia Sinesis Leaf Extract, Chammomilla Recutita (Matricaria) Flower Extract, Iron Oxides (CI 77489, CI 77492)

  • PRINCIPAL DISPLAY PANEL - 4 g Tube Carton

    MINERAL POWDER
    UVA/UVB
    BROAD
    SPECTRUM
    SPF
    50

    SUN PROTECTION
    + OIL CONTROL

    Protects against visible aging
    Sets makeup and reduces shine
    Translucent color blurs imperfections

    BROAD SPECTRUM SPF 50

    Net wt. 0.14 oz. (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    MINERAL SUNSCREEN   SPF 50
    zinc oxide titanium dioxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE240 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE225 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MICA (UNII: V8A1AW0880)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    RESVERATROL (UNII: Q369O8926L)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Product Characteristics
    ColorREDScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-125-051 in 1 CARTON10/14/2020
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35210/14/2020
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-125)
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