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NDC 58892-0354-45 CoTZ Face Prime and Protect SPF 40 (Tinted) 80; 38 mg/g; mg/g Details

CoTZ Face Prime and Protect SPF 40 (Tinted) 80; 38 mg/g; mg/g

CoTZ Face Prime and Protect SPF 40 (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	58892-0354
Product ID	58892-354_5c0ec22e-9d6a-47a5-823c-eb70ec4a799e
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 Face Prime and Protect SPF 40 (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	80; 38
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 58892-0354-45 (58892035445)

Pricing Information	N/A
NDC Package Code	58892-354-45
Billing NDC	58892035445
Package	1 TUBE in 1 CARTON (58892-354-45) / 42.5 g in 1 TUBE
Marketing Start Date	2021-05-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1088fbf6-5790-490d-b272-ec281b4b76fa Details

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

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 Poison 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

Other 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 - 42.5 g Carton Label

CoTZ®

the HEALTHIER

SUNCREEN®

Face

Prime & Protect

Tinted

SPF

40

Sheer Matte

MINERAL SUNSCREEN

PA +++

FACIAL PRIMER

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel - 42.5 g Carton Label

INGREDIENTS AND APPEARANCE

COTZ FACE PRIME AND PROTECT SPF 40 (TINTED)

titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58892-354
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	80 mg in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	38 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone 20 (UNII: H8YMB5QY0D)
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)
Brown Iron Oxide (UNII: 1N032N7MFO)
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58892-354-45	1 in 1 CARTON	05/01/2021
1		42.5 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	06/26/2012

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-354)

Name	Address	ID/FEI	Business Operations
Establishment
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-354) , PACK(58892-354)

Revised: 5/2021

Document Id: 5c0ec22e-9d6a-47a5-823c-eb70ec4a799e

Set id: 1088fbf6-5790-490d-b272-ec281b4b76fa

Version: 1

Effective Time: 20210521