Mychelle Dermaceuticals Sun Shield Clear Spf 30
FDA Label NDC 72805-041

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 Clear Spf 30 (NDC 72805-041). 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 ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Active Ingredients

Zinc Oxide 12%

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

Do not puncture or incinerate can.

  • Keep away from fire and flames.
  • For external use only.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - When Using

  • When using this product keep out of eyes.
  • Rinse with water to remove.

Otc - Stop Use

  • 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.
  • Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray.
  • 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

Bentonite, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

Other Information

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

Principal Display Panel - 177 Ml Bottle Label

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Clear Spray SPF 30
Water Resistant

Broad-spectrum Protection
Mineral-Rich Bentonite Clay
& Jojoba, Condition & Balance

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL

Principal Display Panel (177 mL Bottle Label)

Principal Display Panel (177 mL Bottle Label)

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