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

  • NDC Code(s): 83369-001-01
  • Packager: Smalls Brand LLC DBA Roe Wellness
  • Category: HUMAN OTC DRUG LABEL

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 April 19, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients:

    Titanium DIoxide 23.9%

    Zinc Oxide 24.1 %

    Purpose: Sunscreen

  • PURPOSE

    Uses:

    • Helps prevent sunburn
  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • WARNINGS

    Warning:

    • For external use only. Do not use on broken or damaged skin
    • When using this product keep out of eyes. Rinse with water to remove.
  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply liberally 15 minutes before sun or water exposure. Works best on moisturized skin. Reapply:
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients: Silca, 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

    roe wellness

    spf 50 mineral powder

    borad spectrum

    0.21 oz 6g

    spf powder carton

  • INGREDIENTS AND APPEARANCE
    SPF 50 MINERAL POWDER SUNSCREEN 
    titanium dioxide, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83369-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23.9 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83369-001-016 g in 1 CARTON; Type 0: Not a Combination Product04/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02004/13/2023
    Labeler - Smalls Brand LLC DBA Roe Wellness (058449263)
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