FDA.reportPublic FDA data

SKIN BRIGHTENING

Manufacturer
THEFACESHOP CO., LTD. | THEFACESHOP NORTH AMERICA, 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#

ProductSKIN BRIGHTENING SPF50
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. Dispense an ade...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 6.0 %

Titanium Dioxide 11.6 %

Zinc Oxide 2.9 %

Purpose

OTC - PURPOSE SECTION

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 onto the puff and apply to skin. 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

Talc, Methyl Methacrylate Crosspolymer, Silica, Nylon-12, Trimethylolpropane Triethylhexanoate, Phenyl Trimethicone, Ethylene/Acrylic Acid Copolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Methicone, Magnesium Myristate, Ethylhexylglycerin, Caprylyl Glycol, Dimethicone, Triethoxycaprylylsilane, Volcanic Ash, Glycyrrhiza Glabra (Licorice) Root Extract, Chenopodium Quinoa Seed Extract, Chamomilla Recutita (Matricaria) Flower Water, Butylene Glycol, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, Water, Rubus Chamaemorus Seed Extract, Saccharomyces Ferment, Phenoxyethanol, Fragrance, Mica (CI 77019), Iron Oxides (CI 77491, CI 77492, CI 77499)

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

SKIN BRIGHTENING

UV SUNSCREEN COMPACT POWDER

V201 APRICOT BEIGE SPF50+ PA+++

Our UV compact keeps skin tone looking clear and bright for long hours.

Features a whitening effect that brightens skin tone.

Contains Perfect Seet to keep skin clean and fresh by taking care of dead skin cells and sebum.

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-372-242020-01-31C16284748780-19d75b9d0-d0ae-f424-e053-dadaa90a57ceSKIN BRIGHTENING UV Sunscreen Compact Powder V201 Apricot Beige 34200372

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-372-24SKIN BRIGHTENINGSPF5011 g in 1 CONTAINERPOWDER111
51523-372-24SKIN BRIGHTENINGSPF501 in 1 CARTONPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-372SKIN BRIGHTENING SPF50 (OCTINOXATE, TITANIUM DIOXIDE AND ZINC OXIDE POWDER) POWDER [THEFACESHOP CO., LTD.]1Legacy NDC, 2 package rows20151001_2047c86b-0edc-0c56-e054-00144ff88e88.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
51523-37251523-372-24

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
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

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
2047c86b-0edd-0c56-e054-00144ff88e882047c86b-0edc-0c56-e054-00144ff88e882015-09-21WarningsExact identifier
spl id: 2047c86b-0edd-0c56-e054-00144ff88e88
spl set id: 2047c86b-0edc-0c56-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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