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  5. Label Information: Cotz Baby

FDA Label for Cotz Baby

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS:
    3. PURPOSE:
    4. USES:
    5. WARNINGS:
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. OTC - WHEN USING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS:
    11. INACTIVE INGREDIENTS:
    12. OTHER INFORMATION:
    13. PRINCIPAL DISPLAY PANEL – COTZ BABY TUBE LABEL
    14. PRINCIPAL DISPLAY PANEL – COTZ BABY CARTON LABEL

Cotz Baby 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.

Other



DRUG FACTS


Active Ingredients:



Zinc Oxide 20%


Purpose:



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 40 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:



C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water


Other Information:



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

    • Manufactured Exclusively For:

    CoTZ® Skincare
    Norristown, PA 19403

    www.cotzskincare.com


Principal Display Panel – Cotz Baby Tube Label



CoTZ®

the HEALTHIER
SUNSCREEN®

Baby

Non-Tinted

SPF
40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g


Principal Display Panel – Cotz Baby Carton Label



CoTZ®

the HEALTHIER
SUNSCREEN®

Baby

Non-Tinted

SPF
40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g


* Please review the disclaimer below.