OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:Zinc Oxide 20%
Zinc Oxide
- Manufacturer
- Skin Apeel, Inc. | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI) | Fallien Cosmeceuticals Ltd.
- Effective date
- 2025-12-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:47
Label at a glance#
ProductSkin Apeel Pure Protect SPF 40 Broad Spectrum
Active ingredientZINC OXIDE
Label structure10 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
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.
INDICATIONS & USAGE SECTION
DIRECTIONS:
• Apply liberally 15 minutes before sun exposure.
• Reapply:
• After 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours
• Children under 6 months: Ask a doctor
• 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 am-2 pm
• Wear long-sleeved shirts, pants, hats, and sunglasses
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: C- Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogren Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
OTHER SAFETY INFORMATION
OTHER INFORMATION: • Protect this product from excessive heat and direct sun
WARNINGS SECTION
WARNINGS:For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
REFERENCES SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
DOSAGE & ADMINISTRATION 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 cuased by the sun.
Apply liberally 15 minutes befor sun exposure.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
skin apeel
organic results • cruelty free
Pure Protect
SPF 40
Broad Spectrum
Water Resistant
(40 Mins)
Non-tinted . zinc oxide
antioxidants c + e
Net Wt. 4 oz/ 113 g
Graphic-Untitled
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0383628205409 | GTIN-13: 0383628205409 EAN-13: 0383628205409 GTIN-12: 383628205409 UPC-A: 383628205409 GTIN storage (14 digits): 00383628205409 | Reference Value.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83628-205-40 | Skin Apeel Pure Protect SPF 40 Broad Spectrum | 113 g in 1 BOTTLE, PUMP | CREAM | 113 | 4 |
Products#
Every source-derived product name is available through these pages.
- Skin Apeel Pure Protect SPF 40 Broad Spectrum
- Zinc Oxide
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- CAPRYLHYDROXAMIC ACID
- CYCLOMETHICONE 6
- GLYCERIN
- PEG-10 DIMETHICONE (600 CST)
- TETRAHEXYLDECYL ASCORBATE
- TROLAMINE
- CAPRYLYL GLYCOL
- POLYSORBATE 20
- ALKYL (C12-15) BENZOATE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- EDETATE DISODIUM
- DIMETHICONOL (2000 CST)
- MICROCRYSTALLINE WAX
- POLYGLYCERYL-4 ISOSTEARATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- .ALPHA.-TOCOPHEROL ACETATE
- WATER
- DIMETHICONE 100
- PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)
- HYDROGEN DIMETHICONE (20 CST)
- CYCLOMETHICONE 5
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- SODIUM CHLORIDE
- TRIETHOXYCAPRYLYLSILANE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83628-205 | 83628-205-40 |
| 58892-205 |
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 |
|---|---|---|---|---|---|---|
| Skin Apeel Pure Protect SPF 40 Broad Spectrum | ZINC OXIDE | Skin Apeel, Inc. | 18e78c7f-1523-a4f4-e063-6394a90aed97 | 2025-12-08 | Warnings | 83628-205-40 83628-205 83628020540 457649ce-9417-d1f4-e063-6394a90a1e83 18e78c7f-1523-a4f4-e063-6394a90aed97 |
| Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide | ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 1bbd14ec-4240-f0c2-e063-6394a90a2c07 | 2024-06-25 | Warnings | 58892-205 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.