COTZ FACE MOISTURE- 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:

Zinc Oxide 16%

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:

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Other Information:

Manufactured Exclusively For:
CoTZ® Skincare
Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®
the HEALTHIER SUNSCREEN®

Face
Moisture

Lightly Tinted

SPF
35

Hydrate & Protect
MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Carton Label

Principal Display Panel – Tube Label

CoTZ®
the HEALTHIER SUNSCREEN®

Face
Moisture

Lightly Tinted

SPF
35

Hydrate & Protect
MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Tube Label
COTZ FACE MOISTURE 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-360
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide160 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CERAMIDE NP (UNII: 4370DF050B)  
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)  
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-360-421 in 1 CARTON02/04/2019
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 finalpart35202/04/2019
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-360)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-360) , PACK(58892-360)

Revised: 1/2021
Document Id: 9080b7e7-0a7d-49a6-b8fa-39f015b39447
Set id: db682516-6c8f-4009-a9ec-e21dfc64ce15
Version: 2
Effective Time: 20210112
 
Fallien Cosmeceuticals, LTD