Label: SHUNLY NATURAL COVER SPF50- titanium dioxide, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

    Titanium Dioxide 10%

    Zinc Oxide 3%

  • PURPOSE:

    Sunscreen

    Sunscreen

  • USES:

    Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin 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 the 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
      • 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-sleeved shirts, pants, hats, and sunglasses
  • INACTIVE INGREDIENTS:

    Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate, PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, 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 83642

    www.shunlyskincare.com

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

  • Principal Display Panel – 53 g Bottle Label

    shunly®

    A BOTTLE
    FULL OF SKINCARE

    Natural Cover

    SPF50

    Broad Spectrum UV Defense

    Satin Finish With Hydrate & Antioxidants

    FUSION FORMULA®with
    Physical Filters / C / E

    Water Resistant (40 minutes)

    NET. WT. 1.8 oz | 53 g

    Principal Display Panel – 53 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    SHUNLY NATURAL COVER SPF50 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81381-258
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE100 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISODODECANE (UNII: A8289P68Y2)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81381-258-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/14/2023
    Labeler - Shunly Skin Care (040374013)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372analysis(81381-258)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000manufacture(81381-258) , pack(81381-258)