COTZ LIP BALM- 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 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 2 hours

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic 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, Flavor, 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:

Not tested on animals

Principal Display Panel - 4.5 g Carton Label

CoTZ®
the HEALTHIER
SUNCREEN®

Lip Balm

Lightly Tinted

100% Free of
Chemical Sunscreens,
Lanolin, Gluten

PROTECT & MOISTURIZE

SPF 45 Broad Spectrum • Water Resistant (80 Minutes)

Net Wt. .14 oz/4.5 g

Principal Display Panel - 4.5 g Carton Label
COTZ LIP BALM 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-124
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)  
CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
KIWI FRUIT OIL (UNII: 66086CWP3Q)  
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:58892-124-451 in 1 CARTON05/01/2021
14.5 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 finalpart35204/15/2019
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-124)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-124) , PACK(58892-124)

Revised: 5/2021
Document Id: 1d2f2ef3-f560-4af2-b2d7-e6f8caea9524
Set id: 479a7d82-a068-4c2e-b50b-555c40e13e37
Version: 1
Effective Time: 20210501
 
Fallien Cosmeceuticals, LTD