FDA Label for Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Protect

View Indications, Usage & Precautions

Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 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.

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DRUG FACTS


Active Ingredient



Zinc Oxide 21%


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



  • SHAKE WELL BEFORE USE.
  • 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
  • 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



Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water


Other Information



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

Principal Display Panel - 177 Ml Tube Label



MyCHELLE®
DERMACEUTICALS

PROTECT

Replenishing Solar
Defense Body Lotion
SPF 50 Water Resistant

Broad-spectrum Protection,
Coconut Oil & Shea Butter
Moisturize & Soothe

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL


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