FDA Label for Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50 Broad Spectrum
View Indications, Usage & Precautions
Mychelle Dermaceuticals Replenishing Solar Defense Body 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 Ingredients
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. 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
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
SUN
PROTECTION
Replenishing
Solar Defense
Body Lotion
SPF 50
Broad Spectrum
ANTI-AGING
MyChelle®
dermaceuticals
REEF
SAFE
WATER
RESISTANT
6 fl oz / 177 mL
* Please review the disclaimer below.
