FDA.reportPublic FDA data

SkinCeuticals Silymarin CF Acne Treatment

Manufacturer
L'Oreal USA Products Inc | Cosmetic Essence, LLC | Cosmetique Active Production | Interspray
Effective date
2023-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:03:55

Label at a glance#

ProductSkinCeuticals Silymarin CF Acne Treatment
Active ingredientSALICYLIC ACID
Label structure20 sections

Indications and uses

- for the treatment of acne - reduces the number and severity of acne blemishes and allows skin to heal

Dosage and administration

- clean the skin thoroughly before applying this product - 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

Storage and handling

store in a cool, dark place

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION


Salicylic acid 0.5%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Uses

INDICATIONS & USAGE SECTION

- for the treatment of acne

- reduces the number and severity of acne blemishes and allows skin to heal

Warnings

WARNINGS SECTION

For external use only

Flammable until dry.

SAFE HANDLING WARNING SECTION

Keep away from flames and heat.

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more liekly 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

- clean the skin thoroughly before applying this product

- 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

Other information

STORAGE AND HANDLING SECTION

store in a cool, dark place

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, alcohol denat., ascorbic acid, propylene glycol, dipropylene glycol, laureth-23, silybum marianum fruit extract, sodium citrate, ferulic acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-811-1660 Monday - Friday (9 a.m. - 5 p.m. CST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199308salicylic acid 0.5 % Topical SolutionPSN4
199308salicylic acid 5 MG/ML Topical SolutionSCD4
199308salicylic acid 0.5 % Topical SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-068-01SkinCeuticals Silymarin CF Acne Treatment30 mL in 1 BOTTLESOLUTION304
49967-068-01SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-02SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-02SkinCeuticals Silymarin CF Acne Treatment55 mL in 1 BOTTLESOLUTION554
49967-068-03SkinCeuticals Silymarin CF Acne Treatment1 in 1 CARTONSOLUTION14
49967-068-03SkinCeuticals Silymarin CF Acne Treatment15 mL in 1 BOTTLESOLUTION154
49967-068-04SkinCeuticals Silymarin CF Acne Treatment10 in 1 CARTONSOLUTION104
49967-068-04SkinCeuticals Silymarin CF Acne Treatment4 mL in 1 VIALSOLUTION44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-068SKINCEUTICALS SILYMARIN CF ACNE TREATMENT (SALICYLIC ACID) SOLUTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 8 package rows20231212_aa439d77-7ba5-4699-8e8b-3bba35f5094d.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49967-06849967-068-01, 49967-068-02, 49967-068-03, 49967-068-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPROPYLENE GLYCOLE107L85C40IACT
LAURETH-23N72LMW566GIACT
MILK THISTLEU946SH95EEIACT
SODIUM CITRATE1Q73Q2JULRIACT
FERULIC ACIDAVM951ZWSTIACT

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
SkinCeuticals Silymarin CF Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incaa439d77-7ba5-4699-8e8b-3bba35f5094d2023-12-11WarningsExact identifier
ndc (package): 49967-068-03
ndc (package): 49967-068-02
ndc (package): 49967-068-01
ndc (package): 49967-068-04
ndc (product): 49967-068
ndc11 (package): 49967006804
ndc11 (package): 49967006803
ndc11 (package): 49967006802
ndc11 (package): 49967006801
spl id: 2b72a13a-b70e-4947-8705-c64d4d0d47f8
spl set id: aa439d77-7ba5-4699-8e8b-3bba35f5094d

Reported adverse events (FAERS/openFDA)#

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