COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED)- 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 8%

Zinc Oxide 3.8%

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:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone. Dimethicone Crosspolymer. Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone

Other Information:

Manufactured Exclusively For:
CoTZ® Skincare
Norristown. PA 19403

www.cotzskincare.com

Principal Display Panel – 42.5 g Carton Label

CoTZ®

the HEALTHIER
SUNSCREEN®

Face
Prime & Protect

Non-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
COTZ FACE PRIME AND PROTECT SPF 40 (NON-TINTED) 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-348
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide80 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide38 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-348-451 in 1 CARTON11/15/2018
142.5 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 finalpart35211/15/2018
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-348)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-348) , PACK(58892-348)

Revised: 6/2021
Document Id: a4283ade-af62-4800-accf-3861b87629d8
Set id: f106f52b-2157-46c7-9f7c-50f43a649050
Version: 1
Effective Time: 20210616
 
Fallien Cosmeceuticals, LTD