COTZ PLUS SPF 58  SUNSCREEN - titanium dioxide and 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 10%

Zinc Oxide 3%

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:

Acrylates C10-30 Alkyl Acrylates Crosspolymer, Butylene Glycol, Butyloctyl Salicylate, Butylparaben, Capric/Caprylic Triglyceride, Cetearyl Alcohol, Cetearyl Glucoside, Cyclomethicone, Dimethicone, Ethylhexyl Hydroxystearate Benzoate, Glyceryl Stearate, Iron Oxides, Isobutylparaben, Isopropylparaben, Melissa Officinalis (Balm Mint) Leaf Extract, Octyldodecyl Neopentanoate, PEG-100 Stearate, Phenoxyethanol, Retinyl Palmitate, Simethicone, Sorbitan Laurate, Styrene/Acrylates Copolymer, Talc, Tocopherol, Tocopheryl Acetate, Tricontanyl PVP, Trisodium EDTA, Water, Xanthan Gum

Other Information:

Principal Display Panel – 2.5 oz Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ®

PLUS

The Healthier SunscreenTM

Balanced Mineral Complex™

#1 Rated UV Protection*

Will Not Irritate or Sting

Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis

100% Free of:

Chemical Sunscreens & Oils

SPF 58 Broad

Spectrum

UVA-UVB

Blends
Translucent

Water
Resistant
(40 minutes)

Net Wt. 2.5 oz/70.0 g

Principal Display Panel – 2.5 oz Carton Label
COTZ PLUS SPF 58   SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-070
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 100 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 30 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Butylene Glycol (UNII: 3XUS85K0RA)  
Butylparaben (UNII: 3QPI1U3FV8)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Cyclomethicone (UNII: NMQ347994Z)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Trisodium (UNII: 420IP921MB)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Isobutylparaben (UNII: 0QQJ25X58G)  
Isopropylparaben (UNII: A6EOX47QK0)  
Melissa Officinalis Leaf (UNII: 50D2ZE9219)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
PEG-100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Sorbitan Monolaurate (UNII: 6W9PS8B71J)  
Talc (UNII: 7SEV7J4R1U)  
Tocopherol (UNII: R0ZB2556P8)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Tricontanyl Povidone (4 Tricontanyl Branches/Repeat) (UNII: N0SS3Q238D)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58892-070-58 1 in 1 CARTON
1 70 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/03/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
Name Address ID/FEI Business Operations
Custom Analytics LLC 144949372 ANALYSIS(58892-070)
Establishment
Name Address ID/FEI Business Operations
Process Technologies & Packaging 809172885 MANUFACTURE(58892-070) , PACK(58892-070)

Revised: 1/2013
Document Id: ef82223e-f4df-4917-baae-d305ad052fb6
Set id: 649dbe58-a0a1-494a-a1d7-9c6f3cd83bc6
Version: 1
Effective Time: 20130102
 
Fallien Cosmeceuticals, LTD.