Label: GZE TINTED SUNSCREEN- zinc oxide 3% cream

  • NDC Code(s): 83566-101-01
  • Packager: Guangdong Aimu Biological Technology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 20, 2023

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  • SPL UNCLASSIFIED SECTION

    GZE Tinted Sunscreen

  • ACTIVE INGREDIENT

    Zinc Oxide 3%

  • PURPOSE

    HELPS PREVENT UV DAMAGE & SIGNS OF AGING

  • INDICATIONS & USAGE

    SILKY LOTION MATTIFIES WITH A SHEER, NATURAL TINT FOR ALL SKIN TONES
    ​|HELPS PREVENTUV DAMAGE& SIGNS OF AGING

  • WARNINGS

  • WARNINGS

    For external use only, if it gets into eyes 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 OBTAIN seemingly flawless, glowingskin. Perfect for that no-make up look.FORMULATED AS AN ALLIN ONE SUNSCREEN ANDFOUNDATION that provides sheer color coverage,minimizes the appearance of fine lines andwrinkles, and blends naturally to match every skintone.LIGHTWEIGHT AND NON-GREASY FORMULA thatimproves your skin's hydration and texture over
    time.

  • STOP USE

    For external use only, if it 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
    Iron Oxide

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GZE TINTED SUNSCREEN 
    zinc oxide 3% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83566-101
    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
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    RESVERATROL (UNII: Q369O8926L)  
    SOY ISOFLAVONES (UNII: 71B37NR06D)  
    EPICATECHIN (UNII: 34PHS7TU43)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ADENOSINE (UNII: K72T3FS567)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CAPRYLIC ALCOHOL (UNII: NV1779205D)  
    HEXANEDIOL (UNII: ZIA319275I)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MALTOTETRAOSE (UNII: BO88JLT87R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83566-101-0140 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 - Guangdong Aimu Biological Technology Co., Ltd (712647107)
    Registrant - Guangdong Aimu Biological Technology Co., Ltd (712647107)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Aimu Biological Technology Co., Ltd712647107manufacture(83566-101)
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