OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT:Zinc Oxide 16%
Proceuticals Private Label by TiZO tinted replenishing daily protection
- Manufacturer
- Fallien Cosmeceuticals, Ltd | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-07-08
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:14:51
Label at a glance#
ProductProceuticals Private Label by TiZO tinted replenishing daily protection
Active ingredientZINC OXIDE
Label structure9 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: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, Iron Oxide, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane
Crosspolymer
OTHER SAFETY INFORMATION
OTHER INFORMATION:
• Protect this product from excessive heat and direct sun
• May stain some fabrics.
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.
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
Principal Display Panel – 50g Bottle Label
PROCEUTICALS
PRIVATE LABEL by TiZO
tinted replenishing
daily protection
broad spectrum spf 40
with ceramides, zinc oxide
& antioxidants C & E
net wt. 1.75 oz / 50 g
Graphic-Untitled
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-208-50 | Proceuticals Private Label by TiZO tinted replenishing daily protection | 50 g in 1 BOTTLE, PUMP | CREAM | 50 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Proceuticals Private Label by TiZO tinted replenishing daily protection
- Zinc Oxide
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- DIMETHICONE 20
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- HYDROGEN DIMETHICONE (20 CST)
- BROWN IRON OXIDE
- .ALPHA.-TOCOPHEROL ACETATE
- CYCLOMETHICONE 5
- CYCLOMETHICONE 6
- PEG-10 DIMETHICONE (600 CST)
- TETRAHEXYLDECYL ASCORBATE
- VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
- MEDIUM-CHAIN TRIGLYCERIDES
- DIMETHICONOL (2000 CST)
- CERAMIDE 3
- POLYHYDROXYSTEARIC ACID (2300 MW)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-208 | 58892-208-50 |
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 |
|---|---|---|---|---|---|---|
| Proceuticals Private Label by TiZO tinted replenishing daily protection | ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 1cbcf8a6-0e83-f759-e063-6394a90ac14d | 2024-07-08 | Warnings | 58892-208-50 58892-208 58892020850 1cbcfdde-67fc-4361-e063-6294a90a4151 1cbcf8a6-0e83-f759-e063-6394a90ac14d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.