FDA.reportPublic FDA data

MyChelle Dermaceuticals Sun Shield SPF 28 Coconut

Manufacturer
French Transit, Ltd.
Effective date
2022-01-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:26

Label at a glance#

ProductMyChelle Dermaceuticals Sun Shield SPF 28 Coconut Protect
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

SHAKE WELL BEFORE USE. For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup. 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...

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 Oxide11.6%
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

  • SHAKE WELL BEFORE USE.
  • For daily use, apply to clean, dry skin and allow to absorb completely before applying makeup.
  • 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, Fragrance/Parfum, 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

MyCHELLE®
DERMACEUTICALS

PROTECT

Sun Shield SPF 28
Coconut

Broad-spectrum
Protection, Antioxidant-
Rich, Vitamin E & Aloe
Soothe & Nourish

REEF
SAFE

clean
label
PROJECT®
CERTIFIED

2.3 fl oz/68 mL

SAME FORMULA
NEW
LOOK

Principal Display Panel - 68 mL Tube Box
Principal Display Panel - 68 mL Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-051-682024-01-30C16284748780-11030e365-4850-111a-e063-dadaa90a10e2MyChelle ® Dermaceuticals Sun Shield SPF 28 Coconut Protect

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-051-68MyChelle Dermaceuticals Sun Shield SPF 28 Coconut Protect68 mL in 1 TUBELOTION683
72805-051-68MyChelle Dermaceuticals Sun Shield SPF 28 Coconut Protect1 in 1 BOXLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-051MYCHELLE DERMACEUTICALS SUN SHIELD SPF 28 COCONUT PROTECT (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [FRENCH TRANSIT, LTD.]3Legacy NDC, 2 package rows20220107_585fe2c7-3ad5-46e3-85ec-22c9168bbc66.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72805-05172805-051-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Titanium Dioxide15FIX9V2JPACTIB
WATER059QF0KO0RIACT
1,2-HexanediolTR046Y3K1GIACT
Allantoin344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALUMINUM OXIDELMI26O6933IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
Caprylyl Glycol00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
Cetearyl Glucoside09FUA47KNAIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
Dicaprylyl Ether77JZM5516ZIACT
Dimethicone92RU3N3Y1OIACT
GluconolactoneWQ29KQ9POTIACT
GlycerinPDC6A3C0OXIACT
Glyceryl IsostearateHYE7O27HAOIACT
SOYBEAN OIL241ATL177AIACT
Isononyl IsononanoateS4V5BS6GCXIACT
Leuconostoc/Radish Root Ferment FiltrateD2QHA03458IACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
Magnesium Aluminum Silicate6M3P64V0NCIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
Polysorbate 60CAL22UVI4MIACT
POPULUS TREMULOIDES BARK5543O0CEIDIACT
Potassium Sorbate1VPU26JZZ4IACT
Silicon DioxideETJ7Z6XBU4IACT
SqualaneGW89575KF9IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
Tropolone7L6DL16P1TIACT
Xanthan GumTTV12P4NEEIACT

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
74414284-b065-4809-bcef-03c041db4351585fe2c7-3ad5-46e3-85ec-22c9168bbc662022-01-06WarningsExact identifier
spl id: 74414284-b065-4809-bcef-03c041db4351
spl set id: 585fe2c7-3ad5-46e3-85ec-22c9168bbc66

Reported adverse events (FAERS/openFDA)#

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