FDA.reportPublic FDA data

Biore

Manufacturer
Kao USA Inc.
Effective date
2019-04-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:29

Label at a glance#

ProductBiore Blue Agave Baking Soda Acne Cleansing Foam
Active ingredientSALICYLIC ACID
Label structure12 sections

Storage and handling

Other information store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Salicylic acid 0.5%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • clears up acne blemishes
  • penetrates pores to control acne blemishes
  • helps prevent new acne blemishes from forming

WARNINGS SECTION

Warnings

For external use only.

OTC - WHEN USING SECTION

When using this product

  • 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
  • pump product into hands
  • massage over entire face and neck
  • rinse thoroughly
  • for optimal results, use daily

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, sodium c14-16 olefin sulfonate, sorbitol, polysorbate 20, laureth-4 carboxylic acid, sodium laureth sulfate, ethyhexylglycerin, citric acid, fragrance, sodium hydroxide, polyquaternium-39, disodium EDTA, sodium bicarbonate, agave tequilana leaf extract, sodium benzoate

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

www.biore.com

www.facebook.com

@bioreskin

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2018

Made in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

free your pores!

BLUE AGAVE + BAKING SODA

GREAT FOR COMBINATION SKIN

gentle foam targets acne & deep cleans pores

ACNE CLEANSING FOAM

SALICYLIC ACID ACNE TREATMENT

skin purifying technology/oil-free

acne's outta here!

NET WT 6.77 FL. OZ. (200 mL)

10596-190-67-NEW10596-190-67-NEW

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-19010596-190-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM LAURETH SULFATEBPV390UAP0IACT
SORBITOL506T60A25RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM BENZOATEOJ245FE5EUIACT
LAURETH-4 CARBOXYLIC ACIDDW3PIY647YIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYQUATERNIUM-39 (22.5/51/26.5 ACRYLIC ACID/ACRYLAMIDE/DADMAC; 1600000 MW)X2NH1K9F8KIACT
SODIUM BICARBONATE8MDF5V39QOIACT
POLYSORBATE 207T1F30V5YHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
AGAVE TEQUILANA LEAF05545M0E3MIACT

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
bda7d3ff-cfcf-5a48-e053-2a95a90a0db286e20a82-8048-307b-e053-2a91aa0a9a992021-03-16WarningsExact identifier
spl set id: 86e20a82-8048-307b-e053-2a91aa0a9a99

Reported adverse events (FAERS/openFDA)#

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