COTZ SPF 58- titanium dioxide, zinc oxide cream

CoTZ SPF 58 by

Drug Labeling and Warnings

CoTZ SPF 58 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Process Technologies & Packaging, Custom Analytics LLC. 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

• Retains SPF up to 40 minutes of water immersion or perspiring

Warnings: For external use only

• Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
• Do not use if sensitive to ingredients Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
• For use on children less than 6 months of age, consult a doctor.
• Keep this and all medicines out of reach of children
• If swallowed, get medical help or contact a Poison Control Center

Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight

• Continure to rub in until fading occurs, especially in hair bearing areas
• Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.

Inactive Ingredients

Acrylates C10-30 Alkyl

Acrylates Crosspolymer,

Butylene Glycol, Butyloctyl

Salicylate, Butylparaben,

Capric/Caprylic Triglyceride,

Cetearyl Alcohol, Cetearyl

Glucoside, Cyclomethicone,

Dimethicone, EDTA,

Ethylhexyl Hydroxystearate

Benzoate, Glyceryl Stearate,

Iron Oxides, Isobutylparaben,

Isopropylparaben,

Melissa Officinalis (Balm

Mint) Extract, Octyldodecyl

Neopentanoate, PEG-100

Stearate, Phenoxyethanol,

Retinyl Palmitate,

Simethicone, Sorbitan

Laurate, Styrene/Acrylates

Copolymer, Talc, Tocopherol,

Tocopheryl Acetate,

Tricontanyl PVP, Water,

Xanthan Gum

UVA - Same Everyday

UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.

• Extra gentle - no chemical sunscreen filters
• Dries clear
• Oil & PABA free
• Fragrance free

Manufactured exclusively for:
Fallien, West Norriton, PA 19403
www.totalblock.com

Made in USA

Principal Display Panel

Principal Display Panel – Carton Label

NDC: 58892-910-87

Dermatologist Recommended for Sensitive Skin

FALLENE CoTZ®

Contains Only Titanium & Zinc®

WATER-RESISTANT SUN PROTECTION

UVA-UVB SPF 58

Net Wt. 2.5 Oz./ 70 g

INGREDIENTS AND APPEARANCE

COTZ SPF 58   SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-910
Route of Administration	TOPICAL

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 (UNII: 1G56KV7BUJ)
Cyclomethicone (UNII: NMQ347994Z)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Ferrosoferric Oxide (UNII: XM0M87F357)
Isobutylparaben (UNII: 0QQJ25X58G)
Isopropylparaben (UNII: A6EOX47QK0)
Lemon Balm Oil (UNII: MJ76269K9S)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Polyoxyl 100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Sorbitan Monolaurate (UNII: 6W9PS8B71J)
Talc (UNII: 7SEV7J4R1U)
Alpha-Tocopherol (UNII: H4N855PNZ1)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-910-87	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	01/02/2004

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging		809172885	MANUFACTURE, PACK

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS