COTZ MINERAL SUNS STICK - TINTED SPF 45- titanium dioxide, zinc oxide stick 
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 4.0%

Zinc Oxide 5.5%

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 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:

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 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

Manufactured Exclusively For:

CoTZ® Skincare

Norristown, PA 19403

www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®

the HEALTHIER SUNSCREEN®

Mineral Sun Stick

Tinted

SPF
45

SHEER

MINERAL SUNSCREEN

FACE & BODY

SPF 45 Broad Spectrum

Water Resistant (80 Minutes)

Net Wt. 1 oz./30 g.

Principal Display Panel – Carton Label
COTZ MINERAL SUNS STICK - TINTED SPF 45 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-349
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide55 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYLDECANOL (UNII: 151Z7P1317)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
CERESIN (UNII: Q1LS2UJO3A)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GINGER OIL (UNII: SAS9Z1SVUK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-349-011 in 1 CARTON04/01/2022
130 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2022
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-349)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-349) , PACK(58892-349) , LABEL(58892-349)

Revised: 8/2022
Document Id: 6625710b-df56-4379-8f4f-8d1da05cf30d
Set id: 44a6ff9b-8067-4f32-acb2-4ede54c79e6e
Version: 1
Effective Time: 20220815
 
Fallien Cosmeceuticals, LTD