FDA.reportPublic FDA data

Face Reality Advanced Acne Med

Manufacturer
Face Reality
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:08

Label at a glance#

ProductFace Reality Advanced Acne Med
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

For the treatment of acne  Penetrates pores to control acne blemishes, blackheads and whiteheads Helps to keep new acne blemishes from forming

Dosage and administration

Cleanse the skin thoroughly before applying product. Cover the affected area(s) with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day. If going outside, apply sun...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne 
  • Penetrates pores to control acne blemishes, blackheads and whiteheads
  • Helps to keep new acne blemishes from forming

Warnings

WARNINGS SECTION

For external use only

When using this product

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 unnecessary sun exposure and use a sunscreen
  • Avoid contact with the eyes, lips, and mouth
  • Avoid contact with hair and dyed fabrics, which may be bleached by this product 
  • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do not use if you

OTC - DO NOT USE SECTION

  • Have very sensitive skin
  • Are sensitive to benzoyl peroxide

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Cleanse the skin thoroughly before applying product. Cover the affected area(s) with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of the product and ask a doctor.
  • Sensitivity Test for a New User:Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.

Other information:

SPL UNCLASSIFIED SECTION

  • Store at room temperature of 68-77 F (22-25 C).

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Propanediol, Sodium Hyaluronate, Bisabolol, Carbomer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Xanthan Gum, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-477-3077

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0.jpgLabel0.jpgLabel00.jpgLabel00.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308688benzoyl peroxide 2.5 % Topical CreamPSN1
308688benzoyl peroxide 25 MG/ML Topical CreamSCD1
308688benzoyl peroxide 2.5 % Topical CreamSY1

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
70707-156-01Face Reality Advanced Acne Med44 mL in 1 TUBECREAM441
70707-156-01Face Reality Advanced Acne Med1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70707-156FACE REALITY ADVANCED ACNE MED (BENZOYL PEROXIDE) CREAM [FACE REALITY]1Current NDC, 2 package rows20240727_e1eb8496-0611-4dbc-befb-fb43ec164433.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70707-15670707-156-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
HYALURONATE SODIUMYSE9PPT4THIACT
LEVOMENOL24WE03BX2TIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
ndc (package): 70707-156-01
ndc (product): 70707-156
ndc11 (package): 70707015601
spl id: 1e2b31d8-87eb-aeab-e063-6394a90ada6d
spl set id: e1eb8496-0611-4dbc-befb-fb43ec164433

Reported adverse events (FAERS/openFDA)#

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