Label: GZE TINTED SUNSCREEN- zinc oxide 3% cream

  • NDC Code(s): 83566-100-01
  • Packager: Guangzhou Yilong Cosmetics Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 3, 2024

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  • SPL UNCLASSIFIED SECTION

    GZE Tinted Sunscreen

  • ACTIVE INGREDIENT

    Zinc Oxide 3%

  • PURPOSE

    HELPS PREVENT UV DAMAGE 8 SIGNS OF AGING

  • INDICATIONS & USAGE

    SILKY LOTION MATTIFIES WITH A SHEER, NATURAL TINT FOR ALL SKIN TONES

    IHELPS PREVENTUV DAMAGE& SIGNS OF AGING

  • WARNINGS

    For exteral use only, if it gets into eves accidentally, rinse with plenty of water, seek medical attention immediately if you feel unwell.Keep out of reach of children.

  • DO NOT USE

  • WHEN USING

    Super-Light Daily Wrinkle Defense

    INSTANTLY OBTAlN seemingly flawless, glowingskin. Perfect for that no-make up lOOK.FORMULATED AS AN ALLIN ONESUNSCREEN ANDFOUNDATiON that provides sheer color coverage minimizes the appearance of fine lines andwrinkles, and blendsnaturaly to match every sKintone.LIGHTWEIGHT AND NON-GREASY FORMULA thatimproves your skin's hydration and texture overtime.

  • STOP USE

    For external use only, ifit gets into eyes accidentally, rinse with plenty of water, seek medical attention immediately if you feel unwell.Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Squeeze out an appropriate amount of sunscreen and spread evenly on skin

  • STORAGE AND HANDLING

    Store in a cool dry place

  • INACTIVE INGREDIENT

    Water

    Polydimethylsiloxane

    Peg Ppg-1818polydimethylsiloxane

    DIMETHICONE

    PEG-12 DIMETHICONE

    Resveratrol

    SOY ISOFLAVONES

    Epicatechin

    Tocopherol Acetate

    ASCORBYL TETRAISOPALMITATE

    Adenosine

    LAUROYL LYSINE

    Red Myrrh Alcohol

    TRIHYDROXYSTEARIN

    Barkextract Of Salixalba

    Pomegranate Extract

    Haematococcus Pluvialis Extract

    Hydrolyzedcorn Starch

    Polysorbate-80

    Silica Triethoxy Octylsilane

    C12-15 Alcohol Benzoate

    Triisostearic Acidisopropyl Titanium Salt

    Octanol

    Hexanediol

    Sodium Argon

    Ethyl Hexyl Glycerol

    2-Phenoxyethanol

    lron Oxide

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GZE TINTED SUNSCREEN 
    zinc oxide 3% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAUROYL LYSINE (UNII: 113171Q70B)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    EPICATECHIN (UNII: 34PHS7TU43)  
    HEXANEDIOL (UNII: ZIA319275I)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    RESVERATROL (UNII: Q369O8926L)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    MALTOTETRAOSE (UNII: BO88JLT87R)  
    WATER (UNII: 059QF0KO0R)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    ADENOSINE (UNII: K72T3FS567)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-100-0140 mL in 1 TUBE; Type 0: Not a Combination Product07/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/07/2023
    Labeler - Guangzhou Yilong Cosmetics Co.,Ltd. (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yilong Cosmetics Co.,Ltd.712647107manufacture(83566-100)
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