15HR COVER LASTING SPF50- octinoxate, octisalate, titanium dioxide and zinc oxide cream cream

15HR COVER LASTING by

Drug Labeling and Warnings

15HR COVER LASTING by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD., THEFACESHOP NORTH AMERICA, INC., COSMAX INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octinoxate 7.0 %

Octisalate 4.5 %

Titanium Dioxide 11.5 %

Zinc Oxide 4.9 %

Purpose

Sunscreen

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.

Dispense an adequate amount and apply to skin. 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, Trimethylsiloxysilicate, Cyclohexasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Niacinamide, Methylpropanediol, Pentylene Glycol, Hydrogenated Polyisobutene, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, Phenyl Trimethicone, Sorbitan Isostearate, Magnesium Sulfate, Phenoxyethanol, Ozokerite, Dimethicone, Hexyl Laurate, Aluminum Hydroxide, Stearic Acid, Dimethicone Crosspolymer, Saccharomyces Ferment, Triethoxycaprylylsilane, Beeswax, Ethylhexylglycerin, Disodium EDTA, Adenosine, Xanthan Gum, Hydrogenated Castor Oil Isostearate, Volcanic Ash, Chenopodium Quinoa Seed Extract, Water, Rubus Chamaemorus Seed Extract, Fragrance, Mica (CI 77019), Iron Oxides (CI 77492, CI 77499, CI 77491)

QUESTIONS

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

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PRINCIPAL DISPLAY PANEL

THEFACESHOP

15HR COVER LASTING SUNSCREEN FOUNDATION

N203 NATURAL BEIGE

SPF50+ PA+++

The flawless foundation lasts fresh for up to 15 hours.

15 hours coverage

Creates a deeply moisturizing layer on skin.

Contains 40% glow serum with Smart Seed extract.

INGREDIENTS AND APPEARANCE

15HR COVER LASTING  SPF50
octinoxate, octisalate, titanium dioxide and zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.45 g  in 35 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.58 g  in 35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.03 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: 51523-371-23	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(51523-371)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX INC.		689019313	manufacture(51523-371)