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  5. Label Information: Hutton Klein Hk Dermatologists Spf 40 Mineral Based Facial Sunscreen Tinted

FDA Label for Hutton Klein Hk Dermatologists Spf 40 Mineral Based Facial Sunscreen Tinted

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES:
    4. WARNINGS:
    5. OTC - DO NOT USE
    6. OTC - STOP USE
    7. OTC - WHEN USING
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS:
    10. SUN PROTECTION MEASURES:
    11. INACTIVE INGREDIENTS:
    12. OTHER INFORMATION:
    13. PRINCIPAL DISPLAY PANEL – 53 G BOTTLE LABEL

Hutton Klein Hk Dermatologists Spf 40 Mineral Based Facial Sunscreen Tinted Product Label

The following document was submitted to the FDA by the labeler of this product Hutton, Kathleen Md. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


Otc - Do Not Use



Do not use on damaged or broken skin.


Otc - Stop Use



Stop use and ask a doctor if rash occurs.


Otc - When Using



When using this product, keep out of eyes. Rinse with water to remove.


Otc - Keep Out Of Reach Of Children



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

* Please review the disclaimer below.