1. Home
  2. Labeler Index
  3. Hutton, Kathleen Md
  4. 81679-258
  5. Label Information: Spf 50 Mineral Based Facial Sunscreen

FDA Label for Spf 50 Mineral Based Facial Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES:
    4. WARNINGS:
    5. OTC - STOP USE
    6. OTC - WHEN USING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS:
    9. INACTIVE INGREDIENTS:
    10. OTHER INFORMATION:
    11. PRINCIPAL DISPLAY PANEL – 53 G BOTTLE LABEL

Spf 50 Mineral Based Facial Sunscreen 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 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.


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 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

    • 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 50

Mineral Based
Facial Sunscreen

  • Free of Chemical Sunscreens
  • Water-Resistant (40 Minutes)
  • Broad Spectrum
  • Oil and PABA Free

    • Net. Wt. 1.8 oz./ 53 g

    Figure - hkx01 0000 01

    Figure - hkx01 0000 01


* Please review the disclaimer below.