COTZ SILKY FOAM - TINTED- titanium dioxide, zinc oxide aerosol, foam 
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%

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:

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C8-22 Alkyl Acrylates/Methacrylic Acid Crosspolymer, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum. Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Neopentanoate, Polyhydroxystearic Acid, Polymethyl Methacrylate, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

Manufactured Exclusively For:
CoTZ® Skincare
Norristown, PA 19403
www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®
the HEALTHIER SUNSCREEN®

Silky
Foam

Tinted

SPF
30

Vanishing Zinc Oxide
MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Carton Label

Principal Display Panel – Can Label

CoTZ®
the HEALTHIER SUNSCREEN®

Silky
Foam

Tinted

SPF
30

Foaming
MINERAL SUNSCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Can Label
COTZ SILKY FOAM - TINTED 
titanium dioxide, zinc oxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-430
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
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GLYCERETH-26 (UNII: NNE56F2N14)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
MICA (UNII: V8A1AW0880)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)  
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-430-011 in 1 CARTON05/16/2019
1100 g in 1 CAN; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/29/2016
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-430)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-430) , PACK(58892-430)
Establishment
NameAddressID/FEIBusiness Operations
Keystone Industriess014769301MANUFACTURE(58892-430)

Revised: 1/2022
Document Id: 04d6f889-9620-4dd2-bce2-cbbb5c717784
Set id: d63088d7-a1d7-4b56-a7d8-ad217011a8a8
Version: 2
Effective Time: 20220120
 
Fallien Cosmeceuticals, LTD