Indications and uses
Helps prevents 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.
COVERED
- Manufacturer
- Potency No. 710 LLC | Custom Analytics LLC | Fragrance Manufacturing Inc. | Fallien Cosmeceuticals Ltd.
- Effective date
- 2025-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:21:34
Label at a glance#
ProductCOVERED
Active ingredientZINC OXIDE
Label structure9 sections
Dosage and administration
• Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 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...
Label contents#
Full prescribing information#
Active Ingredients:
Zinc Oxide 20%
Purpose:
Sunscreen
Uses:
Helps prevents 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. 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.
Warnings:
Keep out of reach of children
Directions:
• Apply liberally 15 minutes before sun exposure. • Reapply: • After 80 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 Ingredients:
C12-15 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, Hydrogen 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 Information:
- Protect this product from excessive heat and direct sun.
- May stain some fabrics.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0385319205040 | GTIN-13: 0385319205040 EAN-13: 0385319205040 GTIN-12: 385319205040 UPC-A: 385319205040 GTIN storage (14 digits): 00385319205040 | Potency 710 COVERED 205.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85319-205-04 | COVERED | 113 g in 1 BOTTLE, PUMP | CREAM | 113 | 2 |
Products#
Every source-derived product name is available through these pages.
- COVERED
- Zinc Oxide
- CAPRYLYL GLYCOL
- TRIETHOXYCAPRYLYLSILANE
- CYCLOHEXASILOXANE
- DIMETHICONE
- HYDROGEN DIMETHICONE (20 CST)
- TETRAHEXYLDECYL ASCORBATE
- PEG-10 DIMETHICONE (600 CST)
- POLYSORBATE 20
- SODIUM CHLORIDE
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- POLYHYDROXYSTEARIC ACID (2300 MW)
- WATER
- MICROCRYSTALLINE WAX
- TRIETHANOLAMINE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- POLYGLYCERYL-4 ISOSTEARATE
- ALPHA-TOCOPHEROL ACETATE
- CAPRYLHYDROXAMIC ACID
- CYCLOPENTASILOXANE
- C12-15 ALKYL BENZOATE
- GLYCERIN
- DIMETHICONOL (2000 CST)
- PEG-30 DIPOLYHYDROXYSTEARATE
- DIMETHICONE CROSSPOLYMER
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- EDETATE DISODIUM ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85319-205 | 85319-205-04 |
| 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 |
|---|---|---|---|---|---|---|
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3118c3ed-f0f0-f997-e063-6294a90a53a9 | 2025-12-10 | Warnings | 85319-205 |
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3117faeb-1792-1b2e-e063-6294a90a92df | 2025-12-10 | Warnings | 85319-205-04 85319-205 85319020504 459bf744-e43a-54c3-e063-6294a90a1afd 3117faeb-1792-1b2e-e063-6294a90a92df |
| 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.