FDA.reportPublic FDA data

MyChelle Dermaceuticals Sun Shield Non-Tinted

Manufacturer
French Transit, Ltd.
Effective date
2019-02-26
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 Non-Tinted SPF 50 Broad Spectrum
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

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. Children under 6 months: ask a doctor. 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 ...

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 17%

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

  • 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.
    • Children under 6 months: ask a doctor.
  • 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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Bisabolol, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca Seed Oil, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Octyldodecyl Olivate, Oryza Sativa (Rice) Bran Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Other Information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 15 g Container Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUN
PROTECTION

Sun Shield
Stick
SPF 50
Broad Spectrum

NON-TINTED

REEF
SAFE
WATER
RESISTANT

MyChelle®
dermaceuticals

.52 oz / 15 g

Principal Display Panel - 15 g Container Box
Principal Display Panel - 15 g Container Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-100-152021-01-29C16284748780-1ba0f9c33-4d57-a910-e053-dadaa90a0b85MyChelle ® Dermaceuticals Sun Shield Non-Tinted Stick SPF 50 Broad Spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-100-15MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum1 in 1 BOXSTICK11
72805-100-15MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum15 g in 1 CONTAINERSTICK151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-100MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED SPF 50 BROAD SPECTRUM (ZINC OXIDE) STICK [FRENCH TRANSIT, LTD.]1Legacy NDC, 2 package rows20190227_22c2839b-601b-4378-b36d-c41b2d1ea039.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-10072805-100-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
Cannabis Sativa Seed Oil69VJ1LPN1SIACT
CANDELILLA WAXWL0328HX19IACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
Octyldodecyl OleateMCA43PK7MHIACT
GAMMA ORYZANOLSST9XCL51MIACT
AVOCADO OIL6VNO72PFC1IACT
JOJOBA OIL724GKU717MIACT
TocopherolR0ZB2556P8IACT

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
17a8c818-cc56-44b7-903d-da7ee189317022c2839b-601b-4378-b36d-c41b2d1ea0392019-02-26WarningsExact identifier
spl id: 17a8c818-cc56-44b7-903d-da7ee1893170
spl set id: 22c2839b-601b-4378-b36d-c41b2d1ea039

Reported adverse events (FAERS/openFDA)#

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