FDA.reportPublic FDA data

Acne Clarifying Cleanser

Manufacturer
e.l.f. Cosmetics, Inc.
Effective date
2025-10-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:23:06

Label at a glance#

ProductAcne Clarifying Cleanser
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

For the treatment of acne Helps prevent new acne blemishes

Dosage and administration

Cleanse the skin thoroughly before applying medication. Cover the entire affected area 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. Sensitivity Test for...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne
  • Helps prevent new acne blemishes

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.

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 medication. Cover the entire affected area 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. 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 eleswhere on this label.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Glycerin, Zinc PCA, Sodium Benzoate, Hydroxypropyl Methylcellulose, Sodium Hydroxide, Sodium Chloride, Citric Acid, Disodium EDTA, Niacinamide, Tranexamic Acid May Contain: Blue 1 (CI 42090), Yellow 5 (CI 19140)

Questions or comments

OTC - QUESTIONS SECTION

1-888-315-9814

Package Labeling: 76354-415-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package1Outer Package1

Package labeling: 76354-415-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1

label2label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038982salicylic acid 1 % Medicated Liquid SoapPSN6
1038982salicylic acid 10 MG/ML Medicated Liquid SoapSCD6
1038982salicylic acid 1 % Medicated Liquid SoapSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-415-01Acne Clarifying Cleanser115 mL in 1 BOTTLELIQUID1156
76354-415-01Acne Clarifying Cleanser1 in 1 CARTONLIQUID16
76354-415-02Acne Clarifying Cleanser1 in 1 CARTONLIQUID16
76354-415-02Acne Clarifying Cleanser30 mL in 1 BOTTLELIQUID306

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76354-41576354-415-01, 76354-415-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
ZINC PIDOLATEC32PQ86DH4IACT
SODIUM BENZOATEOJ245FE5EUIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORIDE451W47IQ8XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
NIACINAMIDE25X51I8RD4IACT
TRANEXAMIC ACID6T84R30KC1IACT
SALICYLIC ACIDO414PZ4LPZACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
ndc (package): 76354-415-02
ndc11 (package): 76354041502
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
ndc (package): 76354-415-02
ndc (package): 76354-415-01
ndc (product): 76354-415
ndc11 (package): 76354041502
ndc11 (package): 76354041501
spl id: 4134a99c-4dff-a5e2-e063-6394a90a9cd2
spl set id: 0e9be1e3-7fa9-4d70-9c89-cf7501d2380b

Reported adverse events (FAERS/openFDA)#

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