FDA.reportPublic FDA data

CoTZ Pure Botanicals

Manufacturer
Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
Effective date
2021-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:56:38

Label at a glance#

ProductCoTZ Pure Botanicals
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 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 3.0%

Zinc Oxide 10%

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. 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

Butyrospermum Parkii (Shea) Butter (Shea Tree Extract), C12-15 Alkyl Benzoate (from Cranberries & Coconut), Camellia Sinensis (Green Tea) Leaf Extract, Capric/Caprylic Triglyceride (From Coconut), Glyceryl Caprylate (From Coconut), Glyceryl Undecylenate (From Castor Bean & Coconut), Iron Oxides (Natural Mineral), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Oleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Corn), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensis (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water

Other Information:

OTHER SAFETY INFORMATION

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

Manufactured Exclusively For:

CōTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®
the HEALTHIER
SUNCREEN®

Pure Botanicals

Lightly Tinted

SPF
45

Plant Based
Mineral Sunscreen

BODY

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 3 oz/85 g

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

Principal Display Panel – Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CoTZ®
the HEALTHIER
SUNCREEN®

Pure Botanicals

Lightly Tinted

SPF
45

Plant Based
Mineral Sunscreen

Body

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 3 oz/85 g

Principal Display Panel – Tube Label
Principal Display Panel – Tube Label

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-60258892-602-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
MELISSA OFFICINALISYF70189L0NIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
PROPANEDIOL5965N8W85TIACT
ROSEMARY OIL8LGU7VM393IACT
SAGE065C5D077JIACT
SIMMONDSIA CHINENSIS SEED WAX47X6Y9FJJ2IACT
SCLEROCARYA BIRREA SEED OILWDO4TLS35FIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
1-TETRADECENEFW23481S7SIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

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
2c8f184e-669c-4298-813e-0994d601f817345753eb-ac12-4208-9f11-4591a0b6fbad2025-01-23WarningsExact identifier
spl set id: 345753eb-ac12-4208-9f11-4591a0b6fbad

Reported adverse events (FAERS/openFDA)#

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