Mychelle Dermaceuticals Replenishing Solar Defense Body Spf 50
FDA Label NDC 72805-021

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 Body Spf 50 (NDC 72805-021). 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 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 BEFORE USE.
  • 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
  • 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

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

MyCHELLE®
DERMACEUTICALS

PROTECT

Replenishing Solar
Defense Body Lotion
SPF 50 Water Resistant

Broad-spectrum Protection,
Coconut Oil & Shea Butter
Moisturize & Soothe

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL

Principal Display Panel (177 mL Tube Label)

Principal Display Panel (177 mL Tube Label)

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