OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:Zinc Oxide 20%
Zinc Oxide
- Manufacturer
- Fallien Cosmeceuticals, Ltd | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-08-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 00:17:00
Label at a glance#
ProductTiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E
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: 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, 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
• Shake well before use
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 – 113 g Bottle Label
PROCEUTICALS
PRIVATE LABEL by TiZO
non-tinted
mineral sunscreen
20% zinc oxide
broad spectrum spf 40
water resistant (40 minutes)
net wt. 4 oz/ 113 g
Graphic-Untitled
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-322-30 | TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E | 30 g in 1 TUBE | CREAM | 30 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-322 | TIZO ULTRA ZINC NON-TINTED SPF 40 MINERAL SUNSCREEN FOR BODY AND FACE WITH ANTIOXIDANTS C AND E (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 2 | Current NDC, 1 package rows | 20240810_1f417082-5fd1-c95e-e063-6394a90a16ab.zip |
Products#
Every source-derived product name is available through these pages.
- TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E
- Zinc Oxide
- 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
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- CAPRYLHYDROXAMIC ACID
- CYCLOMETHICONE 6
- GLYCERIN
- PEG-10 DIMETHICONE (600 CST)
- TETRAHEXYLDECYL ASCORBATE
- TROLAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-322 | 58892-322-30 |
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 |
|---|---|---|---|---|---|---|
| TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E | ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 1f417082-5fd1-c95e-e063-6394a90a16ab | 2024-08-09 | Warnings | 58892-322-30 58892-322 58892032230 1f417082-5fd2-c95e-e063-6394a90a16ab 1f417082-5fd1-c95e-e063-6394a90a16ab |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.