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  5. Label Information: Cotz Plus Spf 58 Sunscreen

FDA Label for Cotz Plus Spf 58 Sunscreen

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 – 2.5 OZ CARTON LABEL

Cotz Plus Spf 58 Sunscreen 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:



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.


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

Inactive Ingredients:



Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum


Other Information:



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

Principal Display Panel – 2.5 Oz Carton Label



DERMATOLOGIST RECOMMENDED

CoTZ®

PLUS

The Healthier SunscreenTM

Balanced Mineral Complex™

#1 Rated UV Protection*

Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Oils

SPF 58 Broad

Spectrum

UVA-UVB

Blends
Translucent

Water
Resistant
(40 minutes)

Net Wt. 2.5 oz/70.0 g

Principal Display Panel – 2.5 oz Carton Label - cot07 0000 01

Principal Display Panel – 2.5 oz Carton Label - cot07 0000 01


* Please review the disclaimer below.