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  5. Label Information: Cotz Kids Pure Botanicals

FDA Label for Cotz Kids Pure Botanicals

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 – CARTON LABEL
    9. PRINCIPAL DISPLAY PANEL – TUBE LABEL

Cotz Kids Pure Botanicals Product Label

The following document was submitted to the FDA by the labeler of this product Fallien Cosmeceuticals, Ltd. 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 3.0%

Zinc Oxide 10%


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

Inactive Ingredients:



Butyrospermum Parkii (Shea) Butter (Shea Tree Extract), C12-15 Alkyl Benzoate (from Cranberries & Coconut), Camellia Sinensis (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride (From Coconut), Glyceryl Caprylate (From Coconut), Glyceryl Undecylenate (From Castor Bean & Coconut), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Pentaoleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Corn), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensis (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tetrahexyldecyl Ascorbate (From Mixed Citrus and Palm Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water


Other Information:



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

    • Manufactured Exclusively For:
    CōTZ® Skincare
    Norristown, PA 19403

    www.cotzskincare.com


Principal Display Panel – Carton Label



CoTZ®
the HEALTHIER
SUNCREEN®

Kids
Pure Botanicals

Non-Tinted

SPF
45

Plant Based
Mineral Sunscreen

For 6+ Months

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 4 oz/113 g


Principal Display Panel – Tube Label



CoTZ®
the HEALTHIER
SUNCREEN®

Kids
Pure Botanicals

Non-Tinted

SPF
45

Plant Based
Mineral Sunscreen

For 6+ Months

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 4 oz/113 g


* Please review the disclaimer below.