Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar

Manufacturer
Fallien Cosmeceuticals, LTD | Fragrance Manufacturing Inc. | Custom Analytics LLC
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:53:27

Label at a glance#

ProductProceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 sections

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.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 3.8%

Warnings:

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

Warnings:

OTC - DO NOT USE SECTION

Do not use on broken or damaged skin.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Warnings:

OTC - WHEN USING SECTION

Whe using this product, keep out of eyes.

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.

Warnings:

WARNINGS SECTION

For external use only. Do not use on damage 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 Poison Control Center right away.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Uses:

INDICATIONS & USAGE 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.

Package Label:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarProceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-201-85Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar85 g in 1 BOTTLE, PUMPCREAM851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-201PROCEUTICALS PRIVATE LABEL BY TIZO TINTED FACIAL MINERAL SUNSCREEN BACKBAR (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]1Current NDC, 1 package rows20250124_2be9f92a-a041-0595-e063-6394a90af7a8.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-20158892-201-85

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
ndc (package): 58892-201-85
ndc (product): 58892-201
ndc11 (package): 58892020185
spl id: 2be9f92a-a042-0595-e063-6394a90af7a8
spl set id: 2be9f92a-a041-0595-e063-6394a90af7a8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.