FDA.reportPublic FDA data

Biore

Manufacturer
Kao USA Inc.
Effective date
2020-08-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:17:16

Label at a glance#

ProductBiore Blue Agave Baking Soda Acne Scrub
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 2%

OTC - PURPOSE SECTION

Purpose

Acne treatment

INDICATIONS & USAGE SECTION

Uses

  • for the treatment of acne

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
  • squeeze product into hands
  • massage over entire face
  • rinse thoroughly
  • for optimal results, use up to 2-3 times per week

STORAGE AND HANDLING SECTION

Other information

store at room temperature

INACTIVE INGREDIENT SECTION

Inactive ingredients

water, sodium cocoyl isethionate, glycerin, glycol distearate, synthetic wax, ethyoxydiglycol, PEG-6 caprylic/capric glycerides, microcrystalline wax, cetyl alcohol, PEG-12 dimethicone, sodium lauroyl latylate, sodium hydroxide, acrylates/C10-30 alkyl acrylate crosspolymer, xanthan gum, fragrance, menthol, sodium bicarbonate, benzophenone-4, talc, agave tequilana leaf extract, sodium benzoate, red 30, yellow 5 lake.

SPL UNCLASSIFIED SECTION

Questions? 1-888-BIORE-11

www.biore.com

BIORE is a trademark of Kao Corp.

Distributed by Kao USA Inc.

Cincinnati, OH 45214 ©2020

Made in USA of US & Imported Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biore

free your pores!

BLUE AGAVE + BAKING SODA

GREAT FOR COMBINATION SKIN

gently exfoliates & clears acne

ACNE SCRUB

SALICYLIC ACID ACNE TREATMENT

skin purifying technology/oil-free

acne's outta here!

NET WT 4.5 OZ (127 g)

10596-189-45-UPPDATED10596-189-45-UPPDATED

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-189-012021-11-14C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub
10596-189-452021-11-14C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub
10596-189-562021-11-14C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub
10596-189-012021-07-23C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub
10596-189-452021-07-23C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub
10596-189-562021-07-23C16284748780-1c7ccaba7-2334-fd44-e053-dadaa90aa01bBiore Blue Agave + Baking Soda Acne Scrub

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-18910596-189-45, 10596-189-01, 10596-189-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AIACT
CARBOMER COPOLYMER TYPE A71DD5V995LIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SULISOBENZONE1W6L629B4KIACT
TALC7SEV7J4R1UIACT
D&C RED NO. 302S42T2808BIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
PEG-12 DIMETHICONEZEL54N6W95IACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
SALICYLIC ACIDO414PZ4LPZACTIB
SODIUM BENZOATEOJ245FE5EUIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESGO50W2HWO8IACT
AGAVE TEQUILANA LEAF05545M0E3MIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CETYL ALCOHOL936JST6JCNIACT

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
d22ab93f-c4fd-07a4-e053-2a95a90a0a3f93b5962a-7027-86c2-e053-2a95a90a7d842021-12-02WarningsExact identifier
spl set id: 93b5962a-7027-86c2-e053-2a95a90a7d84

Reported adverse events (FAERS/openFDA)#

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