TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED- zinc oxide cream

TiZO Photoceutical AM Replenish Non-Tinted by

Drug Labeling and Warnings

TiZO Photoceutical AM Replenish Non-Tinted by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD, Custom Analytics LLC, Fragrance Manufacturing Inc. (FMI). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Zinc Oxide 16%

Purpose:

Sunscreen

Uses:

Helps prevents 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 reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant product if swimming or sweating.
• Reapply:

  - 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:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Hydrogen Dimethicone Silsesquioxane Crosspolymer

Other Information:

• Protect this product from excessive heat and direct sun.

Principal Display Panel – Carton Label

AM
REPLENISH

Non-Tinted
SPF 40

TIZO®

PHOTOCEUTICAL®

Enhances, protects &
neutralizes free radicals

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

Broad Spectrum SPF 40

Net Wt. 1.75 oz/50 g

Principal Display Panel – Tube Label

TIZO®

PHOTOCEUTICAL

AM
REPLENISH

Non-Tinted

Mineral Sunscreen

Ceramides

Antioxidants C & E

featuring

SKIN FIRM TECHNOLOGY®

SPF 40
Broad Spectrum

1.75 Fl. Oz/50 mL

INGREDIENTS AND APPEARANCE

TIZO PHOTOCEUTICAL AM REPLENISH NON-TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	160 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CERAMIDE NP (UNII: 4370DF050B)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone 20 (UNII: H8YMB5QY0D)
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-107-50	1 in 1 CARTON	07/23/2019
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/05/2018

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(58892-107)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc. (FMI)		793406000	MANUFACTURE(58892-107) , PACK(58892-107)