COTZ SPF 35- zinc oxide lotion

CoTZ SPF 35 by

Drug Labeling and Warnings

CoTZ SPF 35 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Process Technologies & Packaging, Custom Analytics LLC, Harmony Labs Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients:

Zinc Oxide 20%.

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
• 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 medications out of the 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
• Continue 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 exposure, 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 fabrics

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,

Manufactured
exclusively for
Fallene, Ltd.
West Norriton, PA 19403
Made in USA

Principal Display Panel – 3.5oz Carton Label

NDC: 58892-118-01

Dermatologist

Recommended for

Ultra Sensitive Skin

CoTZ®

20% Zinc Oxide

vanishing formula

Pure Mineral

Sun protection

Moisturizing

water resistant

uva/uvb

SPF 35

Net. Wt. 3.5 oz./ 100g

INGREDIENTS AND APPEARANCE

COTZ SPF 35   SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-118
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Caprylyl Glycol (UNII: 00YIU5438U)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Hydroxystearic Acid (UNII: 933ANU3H2S)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Chloride (UNII: 451W47IQ8X)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Trolamine (UNII: 9O3K93S3TK)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-118-01	1 in 1 CARTON
1		100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2011

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

Establishment
Name	Address	ID/FEI	Business Operations
Harmony Labs Inc		105803274	MANUFACTURE, PACK