MyChelle Dermaceuticals Sun Shield Non-Tinted

Manufacturer
French Transit, Ltd.
Effective date
2019-09-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:00:14

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

SHAKE WELL BEFORE USE . For daily use, apply to clean, dry skin and allow to absorb completely before applying make-up. Apply liberally 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 agin...

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 make-up.
  • Apply liberally 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

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

SUN
PROTECTION

Sun Shield
Liquid
SPF 50
Broad Spectrum

NON-TINTED

MyChelle®
dermaceuticals

REEF
SAFE

1 fl oz / 30 mL

Principal Display Panel - 30 mL Bottle Box
Principal Display Panel - 30 mL Bottle Box

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-080-30MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum30 mL in 1 BOTTLE, PUMPLIQUID303
72805-080-30MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum1 in 1 BOXLIQUID13
72805-080-31MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum1 in 1 BOXLIQUID13
72805-080-31MyChelle Dermaceuticals Sun Shield Non-Tinted SPF 50 Broad Spectrum30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-080MYCHELLE DERMACEUTICALS SUN SHIELD NON-TINTED SPF 50 BROAD SPECTRUM (ZINC OXIDE) LIQUID [FRENCH TRANSIT, LTD.]3Legacy NDC, 4 package rows20190910_d52ecb43-01f2-437e-be10-b7681ea81687.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
72805-08072805-080-30, 72805-080-31

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 · Source PDF

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
2389b220-ff07-487c-88f3-84a4ea1e024cd52ecb43-01f2-437e-be10-b7681ea816872019-09-09WarningsExact identifier
spl id: 2389b220-ff07-487c-88f3-84a4ea1e024c
spl set id: d52ecb43-01f2-437e-be10-b7681ea81687

Reported adverse events (FAERS/openFDA)#

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