FDA.reportPublic FDA data

BARE SKIN

Manufacturer
THEFACESHOP CO., LTD. | THEFACESHOP NORTH AMERICA, INC.
Effective date
2015-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:45

Label at a glance#

ProductBARE SKIN MINERAL COVER SPF27
Active ingredientOCTINOXATE, 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. Apply an adequa...

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3.8 %
Octisalate 2.5 %

Purpose

OTC - PURPOSE SECTION

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.

Apply an adequate amount on face in a light patting motion by using puff.

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, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, TITANIUM DIOXIDE, ZINC OXIDE, SILICA, PHENYL TRIMETHICONE, 1,2-HEXANEDIOL, AMINOPROPYL DIMETHICONE, MICA, POLYMETHYLSILSESQUIOXANE, METHICONE, ALUMINA, GLYCERYL CAPRYLATE, RUBUS CHAMAEMORUS SEED EXTRACT,VOLCANIC ASH, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER WATER, WATER, BUTYLENE GLYCOL, CHENOPODIUM QUINOA SEED EXTRACT, FRAGRANCE, IRON OXIDES (CI 77492, CI 77491, CI77499)

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

BARE SKIN
MINERAL COVER SUNSCREEN POWDER
N203 NATURAL BEIGE SPF27 PA++
Mineral cover powder keeps skin looking flawless for many hours.
Provides a flawless, smooth finish that keeps makeup looking fresh for many hours.
Creates a blurring effect that smoothes out the curves and pores of the skin.
Contains Perfect Seed to keep skin fresh and clean by taking care of dead skin cells and sebum.

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51523-475-372020-01-31C16284748780-19d75b9d0-a630-f424-e053-dadaa90a57ceBARE SKIN MINERAL COVER SUNSCREEN POWDER N203 NATURAL BEIGE SPF27 PA++ 34200475

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51523-475-37BARE SKINMINERAL COVER SPF2715 g in 1 CONTAINERPOWDER151
51523-475-37BARE SKINMINERAL COVER SPF271 in 1 CARTONPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51523-475BARE SKIN MINERAL COVER SPF27 (OCTINOXATE AND OCTISALATE POWDER) POWDER [THEFACESHOP CO., LTD.]1Legacy NDC, 2 package rows20151001_20e4b9dc-fb6e-1dcf-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51523-47551523-475-37

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
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
20e4b9dc-fb6f-1dcf-e054-00144ff8d46c20e4b9dc-fb6e-1dcf-e054-00144ff8d46c2015-09-29WarningsExact identifier
spl id: 20e4b9dc-fb6f-1dcf-e054-00144ff8d46c
spl set id: 20e4b9dc-fb6e-1dcf-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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