MyChelle Dermaceuticals Sun Shield SPF 50 Non-Tinted

Manufacturer
French Transit, Ltd.
Effective date
2022-01-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:29

Label at a glance#

ProductMyChelle Dermaceuticals Sun Shield SPF 50 Non-Tinted Protect
Active ingredientZinc Oxide
Label structure9 sections

Indications and 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.

Dosage and administration

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 sunsc...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 20.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Citric Acid, Diheptyl Succinate, Galactoarabinan, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Jojoba Esters, Polyhydroxystearic Acid, Rubus Idaeus (Raspberry) Seed Oil, Sodium Stearoyl Glutamate, Tocopherol, Water

Other Information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Liquid SPF 50
Non-Tinted

Broad-spectrum
Protection, Bentonite
Clay & Safflower
Smooth & Balance

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

1.0 fl oz/30 mL

SAME FORMULA
NEW
LOOK

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-081-312024-01-30C16284748780-11030e365-0ecd-111a-e063-dadaa90a10e2MyChelle ® Dermaceuticals Sun Shield Liquid SPF 50 Non-Tinted Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-081-31MyChelle Dermaceuticals Sun Shield SPF 50 Non-Tinted Protect30 mL in 1 BOTTLE, DROPPERLIQUID302
72805-081-31MyChelle Dermaceuticals Sun Shield SPF 50 Non-Tinted Protect1 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-081MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 NON-TINTED PROTECT (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]2Legacy NDC, 2 package rows20220108_4f7a1550-73e1-435c-b481-14cb20cabc51.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-08172805-081-31

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
30640f8f-4284-4daa-b0a9-427ecd3ffbe54f7a1550-73e1-435c-b481-14cb20cabc512022-01-07WarningsExact identifier
spl id: 30640f8f-4284-4daa-b0a9-427ecd3ffbe5
spl set id: 4f7a1550-73e1-435c-b481-14cb20cabc51

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.