Mychelle Dermaceuticals Replenishing Solar Defense
FDA Label NDC 72805-030

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 Replenishing Solar Defense (NDC 72805-030). 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.

Label Section Quick Index

Other

DRUG FACTS

Active Ingredient

Zinc Oxide (ZinClear™) 13.5%

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

  • For daily use, allow product to absorb completely before applying make-up.
  • Apply liberally 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

Alcohol, Aleurites Moluccana Seed Oil, Aqua (Water), Behenyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

Other Information

Protect this product from excessive heat and direct sun.

Principal Display Panel - 68 Ml Tube Box

SUN
PROTECTION

Replenishing
Solar Defense
SPF 30
Broad Spectrum

Age Defense

REEF
SAFE

MyChelle®
dermaceuticals

2.3 fl oz / 68 mL

Principal Display Panel (68 mL Tube Box)

Principal Display Panel (68 mL Tube Box)

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