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.
Zealios Sun Barrier SPF 45
- Manufacturer
- Personal Best Products Inc. dba Zealios | Swiss American CDMO
- Effective date
- 2023-12-27
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:05:53
Label at a glance#
ProductZealios Sun Barrier SPF 45
Active ingredientZINC OXIDE, OCTINOXATE, OCTISALATE
Label structure8 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 sun...
Storage and handling
Protect this product from excessive heat and direct sun.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredients: | Purpose |
|---|---|
| Zinc Oxide 8.00% | Sunscreen |
| Octinoxate 7.50% | Sunscreen |
| Octisalate 3.00% | 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.
- Stop use and ask a doctor if rash occurs.
- When using this product keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
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
Ascorbyl Palmitate, Butylene Glycol, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Hexyl Isononanoate, Iodopropynyl Butylcarbarnate, Lauryl PEG-9 Polymethylsiloxyethyl Dimethicone, Phenoxyethanol, Purified Water, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylysilane
Other Info
Protect this product from excessive heat and direct sun.
PRINCIPAL DISPLAY PANEL - 88 ml Tube Label
SPORT PERFORMANCE
SUN BARRIER
SPF 45
BROAD SPECTRUM
8% Micronized Zinc Oxide
DRIES
CLEAR
Water Restant (80 min.)
Oil & Fragrance Free
Non-Greasy Sunscreen
3 fl oz (88 ml)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83326-001-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b647-d83d-e063-dadaa90ab31f | Zealios Sun Barrier SPF 45 |
| 83326-001-02 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b647-d83d-e063-dadaa90ab31f | Zealios Sun Barrier SPF 45 |
| 83326-001-03 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-b647-d83d-e063-dadaa90ab31f | Zealios Sun Barrier SPF 45 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83326-001-01 | Zealios Sun Barrier SPF 45 | 946 mL in 1 BOTTLE | CREAM | 946 | 2 | |
| 83326-001-02 | Zealios Sun Barrier SPF 45 | 88 mL in 1 TUBE | CREAM | 88 | 2 | |
| 83326-001-03 | Zealios Sun Barrier SPF 45 | 10 mL in 1 PACKET | CREAM | 10 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Zealios Sun Barrier SPF 45
- ZINC OXIDE, OCTINOXATE, and OCTISALATE
- ZINC OXIDE
- OCTINOXATE
- OCTISALATE
- ASCORBYL PALMITATE
- BUTYLENE GLYCOL
- CYCLOMETHICONE 5
- DIMETHICONE
- DIMETHICONE/PEG-10/15 CROSSPOLYMER
- IODOPROPYNYL BUTYLCARBAMATE
- LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
- PHENOXYETHANOL
- WATER
- VITAMIN A PALMITATE
- SODIUM CHLORIDE
- TRIETHOXYCAPRYLYLSILANE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83326-001 | 83326-001-01, 83326-001-02, 83326-001-03 |
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 |
|---|---|---|---|---|---|---|
| faa78cd9-fbb7-4c9a-a7fa-68a5a1bca20c | 2cbe11ce-3a4b-49a0-a7b9-7eca5e27f798 | 2023-12-27 | Warnings | faa78cd9-fbb7-4c9a-a7fa-68a5a1bca20c 2cbe11ce-3a4b-49a0-a7b9-7eca5e27f798 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.