FDA.reportPublic FDA data

15HR COVER LASTING

Manufacturer
THEFACESHOP CO., LTD. | THEFACESHOP NORTH AMERICA, INC. | COSMAX INC.
Effective date
2015-09-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:43

Label at a glance#

Product15HR COVER LASTING M201 Medium Beige SPF50
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE, OCTISALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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 ad...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.0%

Octisalate 4.5%

Titanium Dioxide 11.5%

Zinc Oxide 4.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

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

OTC - WHEN USING SECTION

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

OTHER SAFETY INFORMATION

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

May stain or damage some fabrics or surfaces.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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)

OTC - QUESTIONS SECTION

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

Distributed by:

SPL UNCLASSIFIED SECTION

THEFACESHOP NORTH AMERICA, INC.

Santa Fe Springs, CA 90670

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-370-222020-01-31C16284748780-19d75b9d0-7999-f424-e053-dadaa90a57ce15HR COVER LASTING Sunscreen Foundation M201 Medium Beige SPF50+PA+++ 34200370

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-370-2215HR COVER LASTINGM201 Medium Beige SPF5035 g in 1 TUBECREAM351
51523-370-2215HR COVER LASTINGM201 Medium Beige SPF501 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-37015HR COVER LASTING M201 MEDIUM BEIGE SPF50 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]1Legacy NDC, 2 package rows20151001_2045df84-49c5-7261-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51523-37051523-370-22

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2045df84-49c6-7261-e054-00144ff8d46c2045df84-49c5-7261-e054-00144ff8d46c2015-09-21WarningsExact identifier
spl id: 2045df84-49c6-7261-e054-00144ff8d46c
spl set id: 2045df84-49c5-7261-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.