CoTZ Sport Non-Tinted by Fallien Cosmeceuticals, LTD / Custom Analytics LLC / Fragrance Manufacturing Inc. (FMI) DRUG FACTS

CoTZ Sport Non-Tinted by

Drug Labeling and Warnings

CoTZ Sport Non-Tinted by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COTZ SPORT NON-TINTED- titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD

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DRUG FACTS

Active Ingredients:

Titanium Dioxide 3.0%

Zinc Oxide 10%

Purpose:

Sunscreen

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.

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 Polson Control Center right away.

Directions:

  • 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:

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), Melissa Officinalis (Balm Mint) Extract (Natural Herb), Olive Oil Polyglyceryl-6 Esters (From Glycerin & Olive Oil), Polyglyceryl-6 Pentaoleate (From Glycerin & Olive Oil), Polyhydroxystearic Acid (From Castor Plant), Propanediol (From Com), Rosemarinus Officinalis (Rosemary) Extract (Natural Herb), Salvia Officinalis (Sage) Leaf Extract (Natural Herb), Sclerocarya Birrea (Marula) Seed Oil (Tree Fruit Extract), Simmondsia Chinensls (Jojoba) Esters (From Natural Plant), Sodium Chloride (Natural Mineral), Sodium Stearoyl Glutamate (From Coconut & Amino Acid), Tetradecane (Derived from Vegetable Oil), Tetrahexyldecyl Ascorbate (From Mixed Citrus and Palm Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water

Other Information:

  • Protect this product from excessive heat and direct sun.

Manufactured Exclusively For:
CoTZ® Skincare
Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel - 113 g Carton Label

CoTZ®

the HEALTHIER
SUNSCREEN®

Sport

Non-Tinted

SPF
45

Active Performance

MINERAL SUNSCREEN

FACE & BODY

Broad Sprectrum SPF 45

Water Resistant (80 minutes)

Net Wt. 4 oz/113 g

Principal Display Panel - 113 g Carton Label
COTZ SPORT NON-TINTED 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58892-604
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
PROPANEDIOL (UNII: 5965N8W85T)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
SAGE (UNII: 065C5D077J)  
SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
1-TETRADECENE (UNII: FW23481S7S)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58892-604-041 in 1 CARTON01/01/202002/16/2022
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/01/202002/16/2022
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-604)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-604) , PACK(58892-604)

Revised: 1/2025