MyChelle Dermaceuticals Sun Shield Unscented

Manufacturer
French Transit, Ltd.
Effective date
2019-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:37

Label at a glance#

ProductMyChelle Dermaceuticals Sun Shield Unscented SPF 28 Broad Spectrum
Active ingredientZinc Oxide, Titanium Dioxide
Label structure8 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

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 ot...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Zinc Oxide (ZinClear™)11.6%
PurposeSunscreen
Titanium Dioxide0.67%
PurposeSunscreen

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

  • 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

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Allantoin, Aloe Barbadensis Leaf Juice Powder, Alumina, Aqua (Water), Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Coco-Caprylate/Caprate, Dicaprylyl Ether, Fructooligosaccharides (D-beta), Gluconolactone, Glycerin, Glyceryl Isostearate, Glycine Soja (Soybean) Oil, Isononyl Isononanoate, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Magnesium Aluminum Silicate, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Polysorbate 60, Populus Tremuloides Bark Extract, Potassium Sorbate, Simethicone, Squalane, Tocopheryl Acetate (D-alpha), Trisodium Ethylenediamine Disuccinate, Tropolone, Xanthan Gum

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUN
PROTECTION

Sun Shield
Unscented
SPF 28
Broad Spectrum

REEF
SAFE

MyChelle®
dermaceuticals

2.3 fl oz / 68 mL

PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
PRINCIPAL DISPLAY PANEL - 68 mL Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-060-682021-01-29C16284748780-1ba0f9c33-2ea4-a910-e053-dadaa90a0b85MyChelle ® Dermaceuticals Sun Shield Unscented SPF 28 Broad Spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-060-68MyChelle Dermaceuticals Sun Shield Unscented SPF 28 Broad Spectrum1 in 1 BOXLOTION11
72805-060-68MyChelle Dermaceuticals Sun Shield Unscented SPF 28 Broad Spectrum68 mL in 1 TUBELOTION681

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-060MYCHELLE DERMACEUTICALS SUN SHIELD UNSCENTED SPF 28 BROAD SPECTRUM (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [FRENCH TRANSIT, LTD.]1Legacy NDC, 2 package rows20190226_23a9ee35-aad8-4b18-89bf-1ce42e87ab32.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-06072805-060-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
4856d7aa-4c94-4521-ba9e-a098855eaa0923a9ee35-aad8-4b18-89bf-1ce42e87ab322019-02-25WarningsExact identifier
spl id: 4856d7aa-4c94-4521-ba9e-a098855eaa09
spl set id: 23a9ee35-aad8-4b18-89bf-1ce42e87ab32

Reported adverse events (FAERS/openFDA)#

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