COTZ KIDS PURE BOTANICALS- titanium dioxide, zinc oxide cream 
Fallien Cosmeceuticals, LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 Poison Control Center right away.

Directions:

Reapply:

-
After 80 minutes of swimming or sweating
-
Immediately after towel drying
-
At least every two hours

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 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), Tetrahexyldecyl Ascorbate (From Mixed Citrus and Palm Oil), Tocopherol (From Mixed Fruit & Seed Extracts), Tocopheryl Acetate (From Mixed Fruit & Seed Extracts), Water

Other Information:

Manufactured Exclusively For:
CōTZ® Skincare
Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®
the HEALTHIER
SUNCREEN®

Kids
Pure Botanicals

Non-Tinted

SPF
45

Plant Based
Mineral Sunscreen

For 6+ Months

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 4 oz/113 g

Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

CoTZ®
the HEALTHIER
SUNCREEN®

Kids
Pure Botanicals

Non-Tinted

SPF
45

Plant Based
Mineral Sunscreen

For 6+ Months

Broad Spectrum SPF 45

Water Resistant (80 Minutes)

Net Wt. 4 oz/113 g

Principal Display Panel – Tube Label
COTZ KIDS PURE BOTANICALS 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-603
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:58892-603-041 in 1 CARTON04/15/2019
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 not finalpart35204/15/2019
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-603)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-603) , PACK(58892-603)

Revised: 1/2021
Document Id: 799f230f-cbe5-4740-9db1-24103eaa89a4
Set id: 12a61d6f-d423-43ba-80b3-c3560f9d12ae
Version: 2
Effective Time: 20210112
 
Fallien Cosmeceuticals, LTD