Label: SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Zinc Oxide 19.95%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • For external use only.
    • Do not use on damaged or broken skin.
    • When using this product keep out of eyes. Rinse with water to remove.
    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children. If product is 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 two hours
    • Children under 6 months of age:
      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 10am - 2pm
    • Wear long-sleeved shirts, pants, hats and sunglasses
  • Inactive Ingredients

    Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate

  • Other Information

    • Protect the product in this container from excessive heat and direct sun. Store at room temperature 15º - 30ºC (59º - 86ºF).
  • SPL UNCLASSIFIED SECTION

    Distributed by Alastin Skincare®, Inc.
    Carlsbad, CA 92010.

  • PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton

    NDC 70604-030-02

    SilkSHIELD®
    ALL MINERAL
    SUNSCREEN
    with TriHex Technology®

    ALASTIN®
    SKINCARE

    Broad Spectrum SPF 30 Sunscreen
    Water Resistant (40 minutes)

    1.9 Oz. 53.8g

    PRINCIPAL DISPLAY PANEL - 53.8 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70604-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1995 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    ECTOINE (UNII: 7GXZ3858RY)  
    1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70604-030-021 in 1 CARTON09/17/2021
    153.8 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70604-030-04113 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    3NDC:70604-030-9912 g in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    4NDC:70604-030-0012 in 1 CARTON10/01/2021
    45 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/17/2021
    Labeler - Alastin Skincare, Inc. (085997348)
    Registrant - Wasatch Product Development, LLC (962452533)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wasatch Product Development, LLC962452533MANUFACTURE(70604-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Labs068351753MANUFACTURE(70604-030)
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