COTZ PLUS SPF 58 SUNSCREEN- titanium dioxide, zinc oxide cream

Cotz Plus SPF 58 by

Drug Labeling and Warnings

Cotz Plus SPF 58 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Custom Analytics LLC, Process Technologies & Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
  
  - After 40 minutes of swimming or sweating
  
  - Immediately after towel drying
  
  - At least every 2 hours
Children under 6 months: Ask a doctor
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 10 a.m.-2 p.m.

- Wear long-sleeved shirts, pants, hats, and sunglasses

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:

Protect this product from excessive heat and direct sun
May stain some fabrics

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description
Packaging
1	NDC: 58892-070-58	1 in 1 CARTON
1		70 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/03/2012

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Name	Address	ID/FEI	Business Operations
Establishment
Custom Analytics LLC		144949372	ANALYSIS(58892-070)

Name	Address	ID/FEI	Business Operations
Establishment
Process Technologies & Packaging		809172885	MANUFACTURE(58892-070) , PACK(58892-070)