FDA Label for Mychelle Dermaceuticals Sun Shield Clear Spf 30 Protect

View Indications, Usage & Precautions

Mychelle Dermaceuticals Sun Shield Clear Spf 30 Protect Product Label

The following document was submitted to the FDA by the labeler of this product French Transit, 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 12%


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



Do not puncture or incinerate can.

  • Keep away from fire and flames.
  • For external use only.

Otc - Do Not Use



  • Do not use on damaged or broken skin.

Otc - When Using



  • When using this product keep out of eyes.
  • Rinse with water to remove.

Otc - Stop Use



  • Stop use and ask a doctor if rash and irritation develops and lasts.

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • SHAKE WELL BEFORE USE.
  • Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • At least every 2 hours.
    • 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 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-sleeve shirts, pants, hats and sunglasses.
      •  Children under 6 months: ask a doctor.

Inactive Ingredients



Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water


Other Information



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

Principal Display Panel - 177 Ml Bottle Label



MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Clear Spray SPF 30
Water Resistant

Broad-spectrum Protection
Mineral-Rich Bentonite Clay
& Jojoba, Condition & Balance

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL


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