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NDC 58892-0604-04 CoTZ Sport Non-Tinted 30; 100 mg/g; mg/g Details

CoTZ Sport Non-Tinted 30; 100 mg/g; mg/g

CoTZ Sport Non-Tinted is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Fallien Cosmeceuticals, LTD. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	58892-0604
Product ID	58892-604_db472e03-526b-4e50-8c6a-c3b96ada958f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CoTZ Sport Non-Tinted
Proprietary Name Suffix	n/a
Non-Proprietary Name	Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	30; 100
Active Ingredient Units	mg/g; mg/g
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Fallien Cosmeceuticals, LTD
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58892-0604-04 (58892060404)

Pricing Information	N/A
NDC Package Code	58892-604-04
Billing NDC	58892060404
Package	1 TUBE in 1 CARTON (58892-604-04) / 113 g in 1 TUBE
Marketing Start Date	2020-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b3609331-986c-4b55-90f9-4171ca2163ed Details

Active Ingredients:

Titanium Dioxide 3.0%

Zinc Oxide 10%

Purpose:

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

INGREDIENTS AND APPEARANCE

COTZ SPORT NON-TINTED

titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58892-604
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	30 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58892-604-04	1 in 1 CARTON	01/01/2020
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/01/2020

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-604)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-604) , PACK(58892-604)

Revised: 6/2021

Document Id: db472e03-526b-4e50-8c6a-c3b96ada958f

Set id: b3609331-986c-4b55-90f9-4171ca2163ed

Version: 1

Effective Time: 20210604