FDA.reportPublic FDA data

Naturium Benzoyl Peroxide Cream Cleanser 5%

Manufacturer
e.l.f. Cosmetics, Inc
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:23

Label at a glance#

ProductNaturium Benzoyl Peroxide Cleanser 5%
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

Helps fight existing acne breakouts and prevents future acne breakouts.

Dosage and administration

Shake Well. gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area. cover the entire affected area and rinse thoroughly. because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.00%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • Helps fight existing acne breakouts and prevents future acne breakouts.

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 if

OTC - STOP USE SECTION

  • irritation becomes severe

​Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake Well.

  • gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
  • cover the entire affected area and rinse thoroughly.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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, stop use of both products and ask a doctor.

Other Information

OTHER SAFETY INFORMATION

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. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN3
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD3
308696benzoyl peroxide 5 % Medicated Liquid SoapSY3

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-123-01Naturium Benzoyl Peroxide Cleanser 5%1 in 1 CARTONCREAM13
76354-123-01Naturium Benzoyl Peroxide Cleanser 5%147 mL in 1 TUBECREAM1473

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-12376354-123-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
ALOE VERA LEAFZY81Z83H0XIACT
XYLITOLVCQ006KQ1EIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPANEDIOL5965N8W85TIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
N-ACETYLGLUCOSAMINEV956696549IACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM PHOSPHATESE337SVY37IACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
SODIUM CITRATE1Q73Q2JULRIACT
DOCUSATE SODIUMF05Q2T2JA0IACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-12-10full-release2026-06-01 00:41:47

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
Naturium Benzoyl Peroxide Cleanser 5%BENZOYL PEROXIDEe.l.f. Cosmetics, Inc0a278590-e98b-7cab-e063-6394a90a4d0e2025-11-07WarningsExact identifier
ndc (package): 76354-123-01
ndc (product): 76354-123
ndc11 (package): 76354012301
spl id: 4309809b-7239-23fd-e063-6294a90ada96
spl set id: 0a278590-e98b-7cab-e063-6394a90a4d0e

Reported adverse events (FAERS/openFDA)#

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