Otc - Active Ingredient
Zinc Oxide 20.0%
Mychelle Sun Shield Liquid Spf 50 Light/medium
FDA Label NDC 76150-331
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bell International Laboratories, Inc for the product Mychelle Sun Shield Liquid Spf 50 Light/medium (NDC 76150-331). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, uses, warnings, directions, inactive ingredients, other information, bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
SHAKE WELL BEFORE USE.
For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
Apply liberally and evenly 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply 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
Agave Tequilana Leaf Extract, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate,Ethyl Ferulate, Glycerin, Hydrolyzed Wheat Protein / PVP Crosspolymer,Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, Water
Other Information
Protect this product from excessive heat and direct sun.
May stain some fabrics.
* Please review the disclaimer below.
