Label: FATAZEN SUNSCREEN LIP BALM STICK lipstick

  • NDC Code(s): 83885-005-01
  • Packager: Guangzhou Guocui Biological Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 17, 2024

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  • Active Ingredient(s)

    EthylhexyI salicylate
    Octocrylene

  • Purpose

    sunscreen

  • Use

    Moisturizes and prevents sunburn

  • Warnings

    For external use only.

  • Do not use

    in children less than 2 months of age

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In
    case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if iritation or rash occurs. These may
    be signs of a serious condition.
    Keep out of reach of children. If swallowved, get medical help or
    contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if iritation or rash occurs. These may
    be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Directions

    Before going out, apply a sufficient amount of sunscreen lip
    balm on your lips to moisturize your lips and effectively prevent
    UV damage to your lips. Supervise children under 6 years of
    age when using this product to avoid swallowing.Store between
    15- 30C (59-86F)

  • Other information

    No data

  • Inactive ingredients

    EthyhexyI palmitate, tridecyl trelliate,t disostetary malate,
    squalane, polyetylene, beeswax. phytosterals, tocopheryl
    acelate, (daily) fragrance

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FATAZEN SUNSCREEN LIP BALM STICK 
    fatazen sunscreen lip balm stick lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83885-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE7 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SQUALANE (UNII: GW89575KF9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    SITOSTEROLS (UNII: G7V636VTDY)  
    HEXADIMETHRINE BROMIDE (UNII: 4C905MSK4W)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83885-005-015 g in 1 CANISTER; Type 0: Not a Combination Product04/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/17/2024
    Labeler - Guangzhou Guocui Biological Technology Co., Ltd. (419547269)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Guocui Biological Technology Co., Ltd.419547269manufacture(83885-005)
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