Label: HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED- titanium dioxide, zinc oxide cream

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

Drug Label Information

Updated December 1, 2023

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  • ACTIVE INGREDIENTS:

    Titanium Dioxide 8%

    Zinc Oxide 3.8%

  • 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 80 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:

    Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18-Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

  • OTHER INFORMATION:

    • Protect this product from excessive heat and direct sun
    • May stain some fabrics
    • Cleanse thoroughly at nighttime
    • PA+++

    MANUFACTURED FOR:
    Kathleeen Hutton MD
    Newport Beach, CA 92660

    WWW.HUTTONKLEIN.COM
    800-909-0060

  • Principal Display Panel – 53 g Bottle Label

    HUTTON KLEIN

    HK
    DERMATOLOGISTS

    SPF 40

    Mineral Based
    Facial Sunscreen

    • Free of Chemical Sunscreens
    • Water-Resistant (80 Minutes)
    • Broad Spectrum
    • Unscented
    • Oil and PABA Free

    Tinted

    Net. Wt. 1.8 oz./ 53 g

    Principal Display Panel – 53 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    HUTTON KLEIN HK DERMATOLOGISTS SPF 40 MINERAL BASED FACIAL SUNSCREEN TINTED 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81679-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Cyclomethicone 6 (UNII: XHK3U310BA)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dimethicone 20 (UNII: H8YMB5QY0D)  
    Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
    Brown Iron Oxide (UNII: 1N032N7MFO)  
    Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
    Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
    PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
    Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81679-203-5053 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/17/2017
    Labeler - Hutton, Kathleen MD (792310955)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Analytics LLC144949372ANALYSIS(81679-203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(81679-203) , PACK(81679-203)
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