FDA.reportPublic FDA data

Acne Face and Body

Manufacturer
Face Reality, Inc.
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:20

Label at a glance#

ProductAcne Face and Body
Active ingredientBENZOYL PEROXIDE
Label structure7 sections

Indications and uses

Adults and children 12 years and over: For the treatment of acne. For acne-prone or oily skin.

Dosage and administration

Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

For the treatment of Acne

Uses

INDICATIONS & USAGE SECTION

Adults and children 12 years and over:

  • For the treatment of acne.
  • For acne-prone or oily skin.

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY. Avoid contact with eyes and eyelids. This product may cause irritation. Mild irritation may be reduced by using the product less frequently. If irritation becomes severe, discontinue use and consult a doctor.

Do not use

OTC - DO NOT USE SECTION

this medication if you have very sensitive skin or if you are sensitive to benzoly peroxide.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Use 1 to 3 times daily on affected skin, work into lather, rinse off thoroughly.

Other Information

SPL UNCLASSIFIED SECTION

May bleach hair or fabrics. Store at room temperature. Keep away from heat or direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Ammonium Lauryl Sulfate, Glycerin, Cellulose Acetate, Disodium Cocoamphodiacetate, Propylene Glycol, Carbomer, Sodium Hydroxide, Fragrance.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Face and BodyFace and Body

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70707-101-01Acne Face and Body180 mL in 1 BOTTLE, PLASTICSHAMPOO, SUSPENSION1803
70707-101-06Acne Face and Body180 mL in 1 BOTTLESHAMPOO, SUSPENSION1803

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-101ACNE FACE AND BODY (BENZOYL PEROXIDE) SHAMPOO, SUSPENSION [FACE REALITY, INC.]3Current NDC, Legacy NDC, 2 package rows20231215_454983d2-4b00-6268-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-10170707-101-06, 70707-101-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
GLYCERINPDC6A3C0OXIACT
CELLULOSE ACETATE3J2P07GVB6IACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
Acne Face and BodyBENZOYL PEROXIDEFace Reality, Inc.454983d2-4b00-6268-e054-00144ff8d46c2023-12-15WarningsExact identifier
ndc (package): 70707-101-06
ndc (package): 70707-101-01
ndc (product): 70707-101
ndc11 (package): 70707010106
ndc11 (package): 70707010101
spl id: 0c864f2d-7b4f-370e-e063-6394a90ae1a4
spl set id: 454983d2-4b00-6268-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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