FDA.reportPublic FDA data

MyChelle ® Dermaceuticals Sun Shield Clear Spray SPF 30 Protect

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 Clear SPF 30 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. Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray. Reapply: After 80 minutes of swimming or sweating. Immediately after towel drying At least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk o...

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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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

Do not puncture or incinerate can.

  • Keep away from fire and flames.
  • 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.

OTC - STOP USE SECTION

  • 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.
  • Spray liberally and evenly 15 minutes before sun exposure. Hold container 4 to 6 inches from skin to apply. Do not spray directly on face. Spray on hands and apply to face. Avoid inhaling or exposing others to spray.
  • Reapply:
    • After 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • 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, Butyloctyl Salicylate, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Coco-Glucoside, Glycerin, Heptyl Undecylenate, Jojoba Esters, Methyl Dihydroabietate, Vanillin, Water

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield
Clear Spray SPF 30
Water Resistant

Broad-spectrum Protection
Mineral-Rich Bentonite Clay
& Jojoba, Condition & Balance

REEF
SAFE

SAME FORMULA
NEW LOOK

clean
label
PROJECT®
CERTIFIED

6.0 fl oz/177 mL

Principal Display Panel - 177 mL Bottle Label
Principal Display Panel - 177 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-041-772024-01-30C16284748780-11030e365-3721-111a-e063-dadaa90a10e2MyChelle ® Dermaceuticals Sun Shield Clear Spray SPF 30 Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-041-77MyChelle Dermaceuticals Sun Shield Clear SPF 30 Protect177 mL in 1 BOTTLE, SPRAYSPRAY1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-041MYCHELLE DERMACEUTICALS SUN SHIELD CLEAR SPF 30 PROTECT (ZINC OXIDE) SPRAY [FRENCH TRANSIT, LTD.]2Legacy NDC, 1 package rows20220108_6d2b0af6-e570-4085-8456-2509ebaea37c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-04172805-041-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
BentoniteA3N5ZCN45CIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Caprylhydroxamic AcidUPY805K99WIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Caprylyl Glycol00YIU5438UIACT
Safflower Oil65UEH262ISIACT
Cetostearyl Alcohol2DMT128M1SIACT
Coco GlucosideICS790225BIACT
GlycerinPDC6A3C0OXIACT
Heptyl UndecylenateW77QUB6GXOIACT
HYDROGENATED JOJOBA OIL, RANDOMIZEDQ47ST02F58IACT
Methyl Dihydroabietate7666FJ0J9FIACT
VanillinCHI530446XIACT

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
48e71612-e5d6-43a1-88fb-793d0673aeda6d2b0af6-e570-4085-8456-2509ebaea37c2022-01-07WarningsExact identifier
spl id: 48e71612-e5d6-43a1-88fb-793d0673aeda
spl set id: 6d2b0af6-e570-4085-8456-2509ebaea37c

Reported adverse events (FAERS/openFDA)#

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