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  5. Label Information: Mineral Lip Sunscreen

FDA Label for Mineral Lip Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS:
    2. PURPOSE:
    3. USES:
    4. WARNINGS:
    5. DIRECTIONS:
    6. INACTIVE INGREDIENTS:
    7. OTHER INFORMATION:
    8. PRINCIPAL DISPLAY PANEL – 4.5 G TUBE LABEL

Mineral Lip 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 4.0%

Zinc Oxide 5.5%


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.


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 10:00 a.m.-2:00 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:



Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil


Other Information:



  • Protect this product from excessive heat and direct sun
  • May stain some fabrics

    • Not tested on animals


Principal Display Panel – 4.5 G Tube Label



HUTTON KLEIN

HK
DERMATOLOGISTS

Mineral Lip
Sunscreen

SPF 45

broad spectrum

water resistant

(80 mins)

Tinted

Net. Wt. .14 oz./ 4.5 g

Principal Display Panel – 4.5 g Tube Label - hut01 0000 01

Principal Display Panel – 4.5 g Tube Label - hut01 0000 01


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