FACE TONE CONTROLLER SPF30- octinoxate, titanium dioxide and zinc oxide cream cream

FACE TONE by

Drug Labeling and Warnings

FACE TONE by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

OCTINOXATE 5.0%

TITANIUM DIOXIDE 3.5 %

ZINC OXIDE 4.9%

Purpose

Sunscreen

Sunscreen

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product keep out of eyes.

Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get

medical help or contact a Poison Control Center right away.

Directions

Apply generously and evenly 15 minutes before sun exposure.
Children under 6 months of age: Ask a doctor.
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
Reapply at least every 2 hours.
Use a water-resistant sunscreen if swimming or sweating.

Apply at the final stage of your skincare routine. Pat skin lightly to boost absorption.

Other Information

Protect the product in this container from excessive heat and direct sun.

May stain or damage some fabrics or surfaces.

Inactive Ingredients

Chamomilla Recutita (Matricaria) Flower Water, Cyclopentasiloxane, Phenyl Trimethicone, Butylene Glycol, Caprylyl Methicone, PEG-10 Dimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Pentylene Glycol, Alcohol Denat., Dimethicone, Methylpropanediol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Isododecane, Trimethylsiloxysilicate, Disteardimonium Hectorite, Magnesium Sulfate, Phenoxyethanol, Tribehenin, Methyl Methacrylate Crosspolymer, Saccharomyces Ferment, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Stearic Acid, Glyceryl Tribehenate/Isostearate/Eicosandioate, Dimethicone Crosspolymer, Water, Triethoxycaprylylsilane, Ethylhexylglycerin, Adenosine, Disodium EDTA, PEG-8 Dimethicone, Volcanic Ash, Chenopodium Quinoa Seed Extract, Rubus Chamaemorus Seed Extract, Fragrance, Ultramarines (CI 77007)

QUESTIONS

Questions or comments? Call 1-866-638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

FACE TONE

SUNSCREEN CONTROLLER

02 FOR SALLOW AND DULL SKIN

SPF30 PA++

Skin tone controller makes dull, flaky

skin to appear brighter and revitalized.

Create a flawless skin tone and appearance.

Helps makeup go on more evenly and

improves its staying power.

Contains over 37% of revitalizing serum

with Perfect Seed*

INGREDIENTS AND APPEARANCE

FACE TONE  CONTROLLER SPF30
octinoxate, titanium dioxide and zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-365
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.75 g  in 35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.23 g  in 35 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.72 g  in 35 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-365-17	1 in 1 CARTON	10/01/2015
1		35 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	10/01/2015

Labeler - THEFACESHOP CO., LTD. (688329416)

Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)

Establishment
Name	Address	ID/FEI	Business Operations
THEFACESHOP CO., LTD.		688329416	label(51523-365)