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 Replenishing Solar Defense Body Lotion SPF 50
- Manufacturer
- French Transit, Ltd.
- Effective date
- 2022-01-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:46:27
Label at a glance#
ProductMyChelle Dermaceuticals Replenishing Solar Defense Body SPF 50 Protect
Active ingredientZinc Oxide
Label structure9 sections
Dosage and administration
SHAKE WELL BEFORE USE. Apply liberally and evenly 15 minutes before sun exposure. 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 measure...
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
Zinc Oxide 21%
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.
- Apply liberally and evenly 15 minutes before sun exposure.
- 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
Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea Butter), Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/ Sebacic Acid Copolymer, Caprylyl Glycol , Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Undaria Pinnatifida Extract, Vanillin, Water
Other Information
- Protect this product from excessive heat and direct sun.
- May stain some fabrics
PRINCIPAL DISPLAY PANEL - 177 mL Tube Label
MyCHELLE®
DERMACEUTICALS
PROTECT
Replenishing Solar
Defense Body Lotion
SPF 50 Water Resistant
Broad-spectrum Protection,
Coconut Oil & Shea Butter
Moisturize & Soothe
REEF
SAFE
SAME FORMULA
NEW LOOK
clean
label
PROJECT®
CERTIFIED
6.0 fl oz/177 mL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 72805-021-68 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3e74-111a-e063-dadaa90a10e2 | MyChelle ® Dermaceuticals Replenishing Solar Defense Body Lotion SPF 50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72805-021-68 | MyChelle Dermaceuticals Replenishing Solar Defense Body SPF 50 Protect | 177 mL in 1 TUBE | LOTION | 177 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- MyChelle Dermaceuticals Replenishing Solar Defense Body SPF 50 Protect
- Zinc Oxide
- WATER
- Arachidyl Alcohol
- Arachidyl Glucoside
- DOCOSANOL
- LEVOMENOL
- Butyloctyl Salicylate
- SHEA BUTTER
- Caprylhydroxamic Acid
- MEDIUM-CHAIN TRIGLYCERIDES
- CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)
- Caprylyl Glycol
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- CETOSTEARYL ALCOHOL
- Cetyl Alcohol
- ANHYDROUS CITRIC ACID
- Coco Glucoside
- COCONUT OIL
- Diheptyl Succinate
- Glycerin
- Methyl Dihydroabietate
- Microcrystalline Cellulose
- POLYHYDROXYSTEARIC ACID (2300 MW)
- KARUM SEED OIL
- Sodium Gluconate
- HYALURONATE SODIUM
- Sodium Stearoyl Glutamate
- COCOA BUTTER
- Tocopherol
- UNDARIA PINNATIFIDA
- Vanillin
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72805-021 | 72805-021-68 |
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 |
|---|---|---|---|---|---|---|
| 0521af79-26f8-4615-a170-722f4cfddff4 | a4df5ddd-1c69-431e-bd9f-45de5915dc69 | 2022-01-06 | Warnings | 0521af79-26f8-4615-a170-722f4cfddff4 a4df5ddd-1c69-431e-bd9f-45de5915dc69 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.