MyChelle Dermaceuticals Sun Shield SPF 50 Medium/Dark

Manufacturer
French Transit, Ltd.
Effective date
2021-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:21

Label at a glance#

ProductMyChelle Dermaceuticals Sun Shield SPF 50 Medium/Dark 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 20.0%

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.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

Agave Tequilana Leaf Extract, Bentonite, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Coco-Glucoside, Diheptyl Succinate, Ethyl Ferulate, Glycerin, Hydrolyzed Wheat Protein / PVPCrosspolymer,Iron Oxides, Jojoba Esters, Maltose, Octyldodecanol, Sodium Gluconate, Tocopherol, Trihydroxystearin, 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
Medium/Dark

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

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

SAME FORMULA
NEW
NAME

1.0 fl oz/30 mL

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-200-302023-01-30C16284748780-1f386c64a-2be2-0266-e053-dadaa90a7c1aMyChelle ® Dermaceuticals Sun Shield SPF 50 Medium/Dark Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-200-30MyChelle Dermaceuticals Sun Shield SPF 50 Medium/Dark Protect1 in 1 BOXLIQUID11
72805-200-30MyChelle Dermaceuticals Sun Shield SPF 50 Medium/Dark Protect30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-200MYCHELLE DERMACEUTICALS SUN SHIELD SPF 50 MEDIUM/DARK PROTECT (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]1Legacy NDC, 2 package rows20210401_964af507-34fd-4967-aab0-3c0e54949fbe.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-20072805-200-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
95c39a3b-767e-4835-a449-68af25e566bc964af507-34fd-4967-aab0-3c0e54949fbe2021-03-25WarningsExact identifier
spl id: 95c39a3b-767e-4835-a449-68af25e566bc
spl set id: 964af507-34fd-4967-aab0-3c0e54949fbe

Reported adverse events (FAERS/openFDA)#

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