FDA Label for Mychelle Dermaceuticals Sun Shield Tinted Spf 50 Broad Spectrum

View Indications, Usage & Precautions

Mychelle Dermaceuticals Sun Shield Tinted Spf 50 Broad Spectrum 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.

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DRUG FACTS


Active Ingredient



Zinc Oxide 21.8%


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. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. 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



  • Apply liberally and evenly 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 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.

Inactive Ingredients



Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Iron Oxides, Jojoba Esters, Lonicera Japonica (Honeysuckle) Flower Extract, Octyldodecanol, Octyldodecyl Oleate, Oryzanol, Oryza Sativa (Rice) Bran Oil, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Trihydroxystearin


Other Information



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

Principal Display Panel - 15 G Container Box



SUN
PROTECTION

Sun Shield
Stick
SPF 50
Broad Spectrum

TINTED

REEF
SAFE
WATER
RESISTANT

MyChelle®
dermaceuticals

.52 oz / 15 g


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