Label: SUNSCREEN POWDER powder

  • NDC Code(s): 83447-001-01
  • Packager: Guangzhou Fantesy Biotechnology Co.,Ltd
  • 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 May 4, 2023

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  • Active ingredients

    Zinc Oxide 25%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn

  • 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 reach of children.
    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Do not use

    Do not use on damaged or broken skin.

  • When using this product

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

  • Stop use

    Stop use and ask a doctor if rash occurs.

  • Keep out of

    Keep out of reach of children.

  • Directions

    Apply liberally to face at least 15 minutes before sun exposure.
    Use a water resistant sunscreen if swimming or sweating.
    Reapply at least every 2 hours.
    Children under 6 months of age: Ask a doctor

  • Other information

    Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    Sericite, Mica, and Silica.

  • PRINCIPAL DISPLAY PANEL

    83447-001-01

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN POWDER 
    sunscreen powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83447-001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    PYROPHYLLITE (UNII: 1U9X05245H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83447-001-013.5 g in 1 BOX; Type 0: Not a Combination Product05/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/05/2023
    Labeler - Guangzhou Fantesy Biotechnology Co.,Ltd (619047084)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Fantesy Biotechnology Co.,Ltd619047084manufacture(83447-001)
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