OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Titanium Dioxide 8%
Zinc Oxide 3.8%
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-07-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:15:00
Label at a glance#
ProductPROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
PURPOSE:Sunscreen
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:
Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone,
Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone
Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18 Methicone,
Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl
Ascorbate, Tocopheryl Acetate
OTHER SAFETY INFORMATION
OTHER INFORMATION:
• Protect this product from excessive heat and direct sun
• PA ++++
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 caused by the sun.
Apply liberally 15 minutes before sun exposure.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 53 g Bottle Label
Proceuticals
PRIVATE LABEL by TiZO
non-tinted
mineral sunscreen
broad spectrum spf 40
water resistant (80 minutes)
net wt. 1.8 oz / 53 g
Graphic-Untitled
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-202-50 | PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen | 53 g in 1 BOTTLE, PUMP | CREAM | 53 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-202 | PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 1 | Current NDC, 1 package rows | 20240711_1ce8c1da-565d-5487-e063-6294a90a1bde.zip |
Products#
Every source-derived product name is available through these pages.
- PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen
- Titanium Dioxide, Zinc Oxide
- LAURYL PEG/PPG-18/18 METHICONE
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
- ZINC OXIDE
- TITANIUM DIOXIDE
- ALUMINUM HYDROXIDE
- DIMETHICONE 20
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- HYDROGEN DIMETHICONE (20 CST)
- CYCLOMETHICONE 6
- CYCLOMETHICONE 5
- PEG-10 DIMETHICONE (600 CST)
- DIMETHICONOL (2000 CST)
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-202 | 58892-202-50 |
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 non-tinted mineral sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 1ce8c1da-565d-5487-e063-6294a90a1bde | 2024-07-10 | Warnings | 58892-202-50 58892-202 58892020250 1ce89dd7-a723-f27f-e063-6294a90affbc 1ce8c1da-565d-5487-e063-6294a90a1bde |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.