Label: TOPIX MINERAL FINISHING SUNSCREEN SPF 30- zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Zinc Oxide 24.7%

  • Purpose

    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.

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

    Stop use and ask a doctor if rash occurs.

    Keep 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 at least every 2 hours

    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 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

    Silica, Mica, Polymethyl Methacrylate, Ascorbic Acid (Vitamin C), Ceramide EOP, Sodium Hyaluronate (Hyaluronic Acid), Tocopherol (Vitamin E), Camellia Sinensis Leaf Extract, CI 77492, CI 77491

  • PRINCIPAL DISPLAY PANEL - 5 g Bottle Box

    MINERAL POWDER

    BRUSH-ON
    SUNSCREEN
    SPF
    30

    SUN PROTECTION
    + OIL CONTROL

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

    BROAD SPECTRUM SPF 30

    Net 0.16 oz. (5 g)

    PRINCIPAL DISPLAY PANEL - 5 g Bottle Box
  • INGREDIENTS AND APPEARANCE
    TOPIX MINERAL FINISHING SUNSCREEN  SPF 30
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE241 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-206-011 in 1 BOX02/26/2024
    15 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM02002/26/2024
    Labeler - Topiderm, Inc (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aopline Health Industry Technology (Guangzhou) Co., Ltd.715076108MANUFACTURE(51326-206)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!