Label: SHUNLY ZN20 TINTED LIGHT MOISTURIZER- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 17, 2024

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  • ACTIVE INGREDIENTS:

    Zinc Oxide 20%

  • PURPOSE:

    Sunscreen

  • USES:

    Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.

  • WARNINGS:

    For external use only. Do not use on damaged or broken 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 swallowed, get medical help or contact a poison control center right away.

  • DIRECTIONS:

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
      • After 40 minutes of swimming or sweating
      • Immediately after towel drying
      • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10 am- 2 pm
      • Wear long sleeve shirts and hats and sunglasses
  • INACTIVE INGREDIENTS:

    Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl- PEG/PPG 10/1 Dimethicone, Cyclohexasiloxa ne. Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone /Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Iron Oxides, Hydrogren Dimethicone, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

  • OTHER INFORMATION:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics.

    FREE FROM: Chemical Sunscreens, Oils, PABA, Parabens, Fragrances

    Manufactured for: Shunly Skin Care LLC

    Meridian, ID 83646

    www.shunlyskincare.com

  • Principal Display Panel – 60 g Bottle Label

    shunly®

    A BOTTLE
    FULL OF SKINCARE

    Zn20+ Tinted

    SPF40 Light
    Moisturizer

    Broad Spectrum UV Defense

    FUSION FORMULA® with
    Zinc Oxide 20% / C / E

    Water Resistant (40 mins)

    NET.WT. 2.1 oz |60 g

    Principal Display Panel – 60 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SHUNLY ZN20 TINTED LIGHT MOISTURIZER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81381-204
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81381-204-6060 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/01/2022
    Labeler - Shunly Skin Care LLC (040374013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(81381-204)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81381-204) , PACK(81381-204)
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