FDA.reportPublic FDA data

FACE TONE

Manufacturer
THEFACESHOP CO., LTD. | THEFACESHOP NORTH AMERICA, INC.
Effective date
2015-09-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:42

Label at a glance#

ProductFACE TONE Controller 01 SPF30
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE
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. Apply at the fi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.0 %
Titanium Dioxide 3.5%
Zinc Oxide 4.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen
Sunscreen
Sunscreen


Uses

OTC - WHEN USING 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.

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

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, 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, Methyl Methacrylate Crosspolymer ,Magnesium Sulfate, Phenoxyethanol, Tribehenin, Saccharomyces Ferment, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Aluminum Hydroxide, Fragrance, Stearic Acid, Dimethicone Crosspolymer, Glyceryl Tribehenate/Isostearate/Eicosandioate, Water, Ethylhexylglycerin, Adenosine, Triethoxycaprylylsilane, Disodium EDTA, PEG-8 Dimethicone, Chenopodium Quinoa Seed Extract, Volcanic Ash, Rubus Chamaemorus Seed Extract, Chromium Oxide Greens (CI 77288)

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
FACE TONE SUNSCREEN CONTROLLER 01 FOR REDDISH 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.

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-361-142020-01-31C16284748780-19d75b9cf-f578-f424-e053-dadaa90a57ce​TFS FACE TONE CONTROLLER SPF30 PA++ 01 34200361

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-361-14FACE TONEController 01 SPF3035 g in 1 TUBECREAM351
51523-361-14FACE TONEController 01 SPF301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-361FACE TONE CONTROLLER 01 SPF30 (OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE CREAM) CREAM [THEFACESHOP CO., LTD.]1Legacy NDC, 2 package rows20151001_1fb93523-eb4f-24ee-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
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 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51523-36151523-361-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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

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
1fb93523-eb50-24ee-e054-00144ff8d46c1fb93523-eb4f-24ee-e054-00144ff8d46c2015-09-14WarningsExact identifier
spl id: 1fb93523-eb50-24ee-e054-00144ff8d46c
spl set id: 1fb93523-eb4f-24ee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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