CoTZ Mineral Suns Stick - Tinted SPF 45

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 00:52:05

Label at a glance#

ProductCoTZ Mineral Suns Stick - Tinted SPF 45
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 2 hours Children under 6 months: Ask a doctor 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: Lim...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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 2 hours
  • Children under 6 months: Ask a doctor

Sun protection measures:

SPL UNCLASSIFIED SECTION

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 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

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 – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®

the HEALTHIER SUNSCREEN®

Mineral Sun Stick

Tinted

SPF
45

SHEER

MINERAL SUNSCREEN

FACE & BODY

SPF 45 Broad Spectrum

Water Resistant (80 Minutes)

Net Wt. 1 oz./30 g.

Principal Display Panel – Carton Label
Principal Display Panel – Carton Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-349-01CoTZ Mineral Suns Stick - Tinted SPF 451 in 1 CARTONSTICK12
58892-349-01CoTZ Mineral Suns Stick - Tinted SPF 4530 g in 1 CYLINDERSTICK302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-349COTZ MINERAL SUNS STICK - TINTED SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]2Current NDC, Legacy NDC, 2 package rows20250112_44a6ff9b-8067-4f32-acb2-4ede54c79e6e.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-34958892-349-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
ndc (package): 58892-349-01
ndc (product): 58892-349
ndc11 (package): 58892034901
spl id: 2fb0bd71-d774-4353-b919-743df1fdf3bd
spl set id: 44a6ff9b-8067-4f32-acb2-4ede54c79e6e

Reported adverse events (FAERS/openFDA)#

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