Mychelle Dermaceuticals Sun Shield Tinted
FDA Label NDC 72805-110

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by French Transit, Ltd. for the product Mychelle Dermaceuticals Sun Shield Tinted (NDC 72805-110). 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 other, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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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

Principal Display Panel (15 g Container Box)

Principal Display Panel (15 g Container Box)

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