FDA.reportPublic FDA data

Biore

Manufacturer
Kao USA Inc.
Effective date
2023-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:17:36

Label at a glance#

ProductBiore Anti Blemish Flash Treatment
Active ingredientSALICYLIC ACID
Label structure13 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

what it does

BIORE ANTI-BLEMISH IN-SHOWER FLASH TREATMENT warms on contact and melts away acne-causing dirt and oil and helps control unwanted breakouts - right in the shower!

Perfect for daily, in-shower use to treat & help prevent acne for oh-so clear skin. #tada

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 2%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Use

clears up acne blemishes and blackheads

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet face
  • squeeze product into dry hands
  • massage over entire face
  • rinse thoroughly

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

Zeolite, PEG-8, Butylene, Glycol, Ethoxydiglycol, Cellulose, Sodium Lauroyl Lactylate, Helianthus Annuus (Sunflower) Seed Wax, Cetearyl Alcohol, Hydroxypropylcellulose, Ceteth-20 Phosphate, Cetyl Dimehticone, Dicetyl Phosphate, Fragrance, BHT, Blue 1 Lake

SPL UNCLASSIFIED SECTION

Questions?

1-888-BIORE-11

www.biore.com

@bioreus

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2019

Made in USA of US and Imported Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

free your pores!

opens pores and targets blemishes

15 SECOND WARMING FACIAL

ANTI-BLEMISH IN-SHOWER FLASH TREATMENT

SALICYLIC ACID ACNE TREATMENT

oil-free

acne's outta here!

NET WT 4.5 OZ (127 g)

10596-191-45-NEW10596-191-45-NEW

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-191-452021-11-14C16284748780-1c7ccaba7-1d5e-fd44-e053-dadaa90aa01bBiore Anti-Blemish In-Shower Flash Treatment
10596-191-452021-07-23C16284748780-1c7ccaba7-1d5e-fd44-e053-dadaa90aa01bBiore Anti-Blemish In-Shower Flash Treatment

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-19110596-191-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIATOMACEOUS EARTH2RF6EJ0M85IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
POWDERED CELLULOSESMD1X3XO9MIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
SALICYLIC ACIDO414PZ4LPZACTIB
CETETH-20 PHOSPHATE921FTA1500IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
ALUMINUM SILICATET1FAD4SS2MIACT

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
0ce45244-4a01-d4ce-e063-6394a90aa0a193b63e84-1b03-56ef-e053-2995a90aded52023-12-19WarningsExact identifier
spl id: 0ce45244-4a01-d4ce-e063-6394a90aa0a1
spl set id: 93b63e84-1b03-56ef-e053-2995a90aded5

Reported adverse events (FAERS/openFDA)#

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