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.
MyChelle Dermaceuticals Sun Shield SPF 28 Unscented
- Manufacturer
- French Transit, Ltd.
- Effective date
- 2022-01-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:18:54
Label at a glance#
ProductMyChelle Dermaceuticals Sun Shield SPF 28 Unscented Protect
Active ingredientZinc Oxide, Titanium Dioxide
Label structure8 sections
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 - PURPOSE SECTION
| Zinc Oxide | 11.6% |
| Purpose | Sunscreen |
| Titanium Dioxide | 0.67% |
| Purpose | Sunscreen |
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.
Warnings
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
- 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
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, 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
Protect this product from excessive heat and direct sun.
PRINCIPAL DISPLAY PANEL - 68 mL Tube Box
MyCHELLE®
DERMACEUTICALS
PROTECT
Sun Shield SPF 28
Unscented
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72805-061-68 | 2024-01-30 | C162847 | 48780-1 | 1030e365-00c4-111a-e063-dadaa90a10e2 | MyChelle ® Dermaceuticals Sun Shield SPF 28 Unscented Protect |
Products#
Every source-derived product name is available through these pages.
- MyChelle Dermaceuticals Sun Shield SPF 28 Unscented Protect
- Zinc Oxide and Titanium Dioxide
- Zinc Oxide
- Titanium Dioxide
- WATER
- 1,2-Hexanediol
- Allantoin
- ALOE VERA LEAF
- ALUMINUM OXIDE
- MEDIUM-CHAIN TRIGLYCERIDES
- Caprylyl Glycol
- CETOSTEARYL ALCOHOL
- Cetearyl Glucoside
- ANHYDROUS CITRIC ACID
- COCOYL CAPRYLOCAPRATE
- Dicaprylyl Ether
- Dimethicone
- Gluconolactone
- Glycerin
- Glyceryl Isostearate
- SOYBEAN OIL
- Isononyl Isononanoate
- Leuconostoc/Radish Root Ferment Filtrate
- LONICERA CAPRIFOLIUM FLOWER
- LONICERA JAPONICA FLOWER
- Magnesium Aluminum Silicate
- POLYHYDROXYSTEARIC ACID (2300 MW)
- Polysorbate 60
- POPULUS TREMULOIDES BARK
- Potassium Sorbate
- Silicon Dioxide
- Squalane
- .ALPHA.-TOCOPHEROL ACETATE, D-
- Trisodium Ethylenediamine Disuccinate
- Tropolone
- Xanthan Gum
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72805-061 | 72805-061-68 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 5cd5c247-10b5-411b-85f0-6f36c5b31795 | 78c14183-deed-46eb-934a-27404686c8da | 2022-01-06 | Warnings | 5cd5c247-10b5-411b-85f0-6f36c5b31795 78c14183-deed-46eb-934a-27404686c8da |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.