15HR COVER LASTING M201 MEDIUM BEIGE SPF50- octinoxate, octisalate, titanium dioxide and zinc oxide cream cream 
THEFACESHOP CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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15HR COVER LASTING Sunscreen Foundation M201 Medium Beige SPF50+PA+++ 34200370

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 or comments? Call 1-866-638-8417

Distributed by:

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

THEFACESHOP

15HR COVER LASTING SUNSCREEN FOUNDATION

M201 MEDIUM 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.

Label

15HR COVER LASTING  M201 MEDIUM BEIGE SPF50
octinoxate, octisalate, titanium dioxide and zinc oxide cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.45 g  in 35 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.03 g  in 35 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.72 g  in 35 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.58 g  in 35 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51523-370-221 in 1 CARTON10/01/2015
135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2015
Labeler - THEFACESHOP CO., LTD. (688329416)
Registrant - THEFACESHOP NORTH AMERICA, INC. (620459193)
Establishment
NameAddressID/FEIBusiness Operations
THEFACESHOP CO., LTD.688329416label(51523-370)
Establishment
NameAddressID/FEIBusiness Operations
COSMAX INC.689019313manufacture(51523-370)

Revised: 9/2015
Document Id: 2045df84-49c6-7261-e054-00144ff8d46c
Set id: 2045df84-49c5-7261-e054-00144ff8d46c
Version: 1
Effective Time: 20150921
 
THEFACESHOP CO., LTD.