FDA.reportPublic FDA data

MyChelle ® Dermaceuticals Replenishing Solar Defense SPF 30 Broad Spectrum

Manufacturer
French Transit, Ltd.
Effective date
2019-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:06

Label at a glance#

ProductMyChelle Dermaceuticals Replenishing Solar Defense SPF 30 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

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 oth...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (ZinClear™) 13.5%

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

  • 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

Alcohol, Aleurites Moluccana Seed Oil, Aqua (Water), Behenyl Alcohol, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Citric Acid, Ergothioneine (L), Ethyl Macadamiate, Glycerin, Glyceryl Isostearate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hordeum Distichon (Barley) Extract, Hydrogenated Palm Glycerides, Hydroxypropyl Methylcellulose, Hydroxypropyl Starch Phosphate, Isodecyl Neopentanoate, Lecithin, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Macadamia Ternifolia Seed Oil, Malic Acid (L), Phellodendron Amurense Bark Extract, Phytic Acid, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Porphyra Umbilicalis (Red Algae) Extract, Potassium Cetyl Phosphate, Santalum Album (Sandalwood) Extract, Sodium Hydroxide, Sodium Lactate, Sodium Stearoyl Lactylate, Tocopherol (D-alpha), Tocopheryl Acetate (D-alpha)

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

Replenishing
Solar Defense
SPF 30
Broad Spectrum

Age Defense

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72805-030-772021-01-29C16284748780-1ba0f9c33-2e6e-a910-e053-dadaa90a0b85MyChelle ® Dermaceuticals Replenishing Solar Defense SPF 30 Broad Spectrum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72805-030-77MyChelle Dermaceuticals Replenishing Solar Defense SPF 30 Broad Spectrum68 mL in 1 TUBELOTION681
72805-030-77MyChelle Dermaceuticals Replenishing Solar Defense SPF 30 Broad Spectrum1 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72805-030MYCHELLE DERMACEUTICALS REPLENISHING SOLAR DEFENSE SPF 30 BROAD SPECTRUM (ZINC OXIDE) LOTION [FRENCH TRANSIT, LTD.]1Legacy NDC, 2 package rows20190223_0b53c2a2-04e5-4e23-8cc6-34673a0d3216.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
72805-03072805-030-77

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GlycerinPDC6A3C0OXIACT
Isodecyl NeopentanoateW60VYE24XCIACT
Ethyl MacadamiateANA2NCS6V1IACT
KUKUI NUT OILTP11QR7B8RIACT
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN9F8ET54T05IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ERGOTHIONEINEBDZ3DQM98WIACT
BARLEY5PWM7YLI7RIACT
MACADAMIA OIL515610SU8CIACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
SANDALWOOD3641YW25N2IACT
PHELLODENDRON AMURENSE BARKPBG27B754GIACT
Glyceryl IsostearateHYE7O27HAOIACT
Sodium Stearoyl LactylateIN99IT31LNIACT
Polyglyceryl-10 PentastearatePMX5872701IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
.ALPHA.-TOCOPHEROL, D-N9PR3490H9IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MALIC ACID, L-J3TZF807X5IACT
LONICERA CAPRIFOLIUM FLOWER5N1WD9784UIACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Hydrogenated Palm GlyceridesYCZ8EM144QIACT
Alcohol3K9958V90MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DOCOSANOL9G1OE216XYIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
Sodium LactateTU7HW0W0QTIACT
FYTIC ACID7IGF0S7R8IIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
Sodium Hydroxide55X04QC32IIACT

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
fc093be6-d401-411b-a337-4108975099910b53c2a2-04e5-4e23-8cc6-34673a0d32162019-02-22WarningsExact identifier
spl id: fc093be6-d401-411b-a337-410897509991
spl set id: 0b53c2a2-04e5-4e23-8cc6-34673a0d3216

Reported adverse events (FAERS/openFDA)#

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