Label: ROE WELLNESS SPF 50 MINERAL POWDER- spf 50 mineral powder powder

  • NDC Code(s): 82723-003-01
  • Packager: Aopline Health Industry Technology (Guangzhou) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Active Ingredients

    Titanium Dioxide 23.9%
    Zinc Oxide 24.1%

  • Purpose

    Sunscreen

  • Uses

    Uses: Helps prevent sunburn.

  • Warnings

    For external use only .
    Do not use on broken or damaged 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 product is swallowed , get medical help or contact a Poison Control Center right away .

  • Directions

    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.

  • Other Information

    Other Information : Sun alert : Limiting sun exposure , wearing protective clothing , using sunscreens may reduce the risks of skin aging , skin cancer , and other harmful effects of the sun

  • Inactive Ingredients

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

  • 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 .

  • Stop use

    Stop use and ask a doctor if rash occurs
    When using this product keep out of eyes . Rinse with water to remove .

  • WHEN USING

    When using this product keep out of eyes . Rinse with water to remove .
    Keep out of reach of children . If product is swallowed , get medical help or contact a Poison Control Center right away .

  • Do not use

    Do not use on broken or damaged skin .
    Stop use and ask a doctor if rash occurs

  • Package Label

    82723-003-01

    82723-003-01

  • INGREDIENTS AND APPEARANCE
    ROE WELLNESS SPF 50 MINERAL POWDER 
    spf 50 mineral powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82723-003
    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
    CERAMIDE NP (UNII: 4370DF050B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER DISPERSION (2:1; 600000 MW 30% AQUEOUS) (UNII: 3EW60Z566Z)  
    .ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, DL- (UNII: H5A1374A6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82723-003-016 g in 1 BOX; Type 0: Not a Combination Product05/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/07/2022
    Labeler - Aopline Health Industry Technology (Guangzhou) Co., Ltd. (715076108)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aopline Health Industry Technology (Guangzhou) Co., Ltd.715076108manufacture(82723-003)
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