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
  • 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 March 20, 2023

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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 not finalpart35205/07/2022
    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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