PROCEUTICALS PRIVATE LABEL BY TIZO TINTED FACIAL MINERAL SUNSCREEN BACKBAR- titanium dioxide, zinc oxide cream

Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar by

Drug Labeling and Warnings

Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Warnings:

Stop use and ask a doctor if rash occurs.

Warnings:

Do not use on broken or damaged skin.

Warnings:

Keep out of the reach of children.

Purpose:

Sunscreen

Warnings:

Whe using this product, keep out of eyes.

Directions:

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating. Immediatley after towel drying. At leat every 2 hours.

Warnings:

For external use only. Do not use on damage 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 Poison Control Center right away.

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

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.

Package Label:

INGREDIENTS AND APPEARANCE

PROCEUTICALS PRIVATE LABEL BY TIZO TINTED FACIAL MINERAL SUNSCREEN BACKBAR 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	80 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	38 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINA (UNII: LMI26O6933)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
IRON OXIDES (UNII: 1K09F3G675)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-201-85	85 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2014

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-201)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-201)