FDA.reportPublic FDA data

CoTZ Face Prime and Protect SPF 40 (Non-Tinted)

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:24

Label at a glance#

ProductCoTZ Face Prime and Protect SPF 40 (Non-Tinted)
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure8 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 - Immediately after towel drying - At least every two 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 p...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 3.8%

Purpose:

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

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.

Warnings:

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure.

Reapply:

  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every two 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 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone. Dimethicone Crosspolymer. Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone

Other Information:

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun.
  • May stain some fabrics.

Manufactured Exclusively For:
CoTZ® Skincare
Norristown. PA 19403

www.cotzskincare.com

Principal Display Panel – 42.5 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®

the HEALTHIER
SUNSCREEN®

Face
Prime & Protect

Non-Tinted

SPF
40

Sheer Matte

MINERAL SUNSCREEN

PA ++++

FACIAL PRIMER

Broad Spectrum SPF 40
Water Resistant (80 minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – 42.5 g Carton Label
Principal Display Panel – 42.5 g Carton Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)42.5 g in 1 TUBECREAM42.52
58892-348-45CoTZ Face Prime and Protect SPF 40 (Non-Tinted)1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-348COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250112_f106f52b-2157-46c7-9f7c-50f43a649050.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-34858892-348-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Aluminum Hydroxide5QB0T2IUN0IACT
Cyclomethicone 6XHK3U310BAIACT
Cyclomethicone 50THT5PCI0RIACT
Dimethicone 20H8YMB5QY0DIACT
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane)UF7620L1W6IACT
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)9E4CO0W6C5IACT
Dimethiconol (2000 CST)T74O12AN6YIACT
Lauryl PEG/PPG-18/18 MethiconeZJ5S27D9NXIACT
Hydrogen Dimethicone (20 CST)12Z59IF64NIACT
PEG-10 Dimethicone (600 CST)8PR7V1SVM0IACT

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
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
ndc (package): 58892-348-45
ndc (product): 58892-348
ndc11 (package): 58892034845
spl id: 9498c109-3155-481c-a847-975cb655f6bc
spl set id: f106f52b-2157-46c7-9f7c-50f43a649050

Reported adverse events (FAERS/openFDA)#

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