Spf 50 Mineral Based Facial Sunscreen Cream
FDA Label NDC 81679-258

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hutton, Kathleen Md for the product Spf 50 Mineral Based Facial Sunscreen (NDC 81679-258). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients:, purpose:, uses:, warnings:, otc - stop use, otc - when using, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

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