FDA.reportPublic FDA data

Salicylacne-2% Clearing Serum

Manufacturer
Valley of the Sun Cosmetics LLC
Effective date
2021-06-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:54

Label at a glance#

ProductSalicylacne-2% Clearing Serum
Active ingredientSALICYLIC ACID
Label structure11 sections

Indications and uses

Use for treatment of acne

Dosage and administration

Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

Use for treatment of acne

Warning

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Allergy Alert: Do not use this product if you have a known allergy to salicylic acid.

When using this product

OTC - WHEN USING SECTION

Skin irritation and dryness is more likely 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 contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

If irritation or sensitivity occurs, stop use of product and consult doctor.

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. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), vegetable (kosher) glycerin, propylene glycol (kosher), alcohol, retinol (vitamin A), tocopheryl acetate (vitamin E), azelaic acid, gluthathione, lactic acid, sodium ascorbyl phosphate (Vitamin C), carica papaya (papaya) fruit extract, citrus paradise (*organic grapefruit) fruit extract, citrus medica limonum (*organic lemon) extract, bromelain (*pineapple stem leaf), sulfur, sodium PCA, PPG-5-Ceteth-20, PEG-40 hydrogenated (castor oil), potassium sorbate, phenoxyethanol, hydroxyethylcellulose, carbomer, citric acid, sodium hydroxide

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
251577salicylic acid 2 % Topical SolutionPSN1
251577salicylic acid 20 MG/ML Topical SolutionSCD1
251577salicylic acid 2 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76523-020-302023-01-30C16284748780-1f386c649-e984-0266-e053-dadaa90a7c1aSalicylacne-2% Clearing Serum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76523-020-30Salicylacne-2% Clearing Serum30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76523-020SALICYLACNE-2% CLEARING SERUM (SALICYLIC ACID) LIQUID [VALLEY OF THE SUN COSMETICS LLC]1Legacy NDC, 1 package rows20210618_c4e802eb-b9a1-55af-e053-2995a90a4ee5.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76523-02076523-020-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
VITAMIN A81G40H8B0TIACT
LACTIC ACID33X04XA5ATIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CARICA PAPAYA WHOLES0U63B0Q51IACT
CITRUS PARADISI WHOLE3FNT9K2294IACT
STEM BROMELAINZLM4P8929RIACT
TECHNETIUM TC-99M SULFUR COLLOID556Q0P6PB1IACT
PPG-5-CETETH-204AAN25P8P4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER 9404Q93RCW27EIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
AZELAIC ACIDF2VW3D43YTIACT
CITRUS MEDICA FRUITZE5Q6PN9ONIACT
PEG-40 CASTOR OIL4ERD2076EFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALTT52TI8BMQ6IACT
CETYL HYDROXYETHYLCELLULOSE (350000 MW)T7SWE4S2TTIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SALICYLIC ACIDO414PZ4LPZACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
3-HEXYLOXYPROPYLENE GLYCOL3485P35DA4IACT
GLUTATHIONEGAN16C9B8OIACT

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
c4e802eb-b9a2-55af-e053-2995a90a4ee5c4e802eb-b9a1-55af-e053-2995a90a4ee52021-06-16WarningsExact identifier
spl id: c4e802eb-b9a2-55af-e053-2995a90a4ee5
spl set id: c4e802eb-b9a1-55af-e053-2995a90a4ee5

Reported adverse events (FAERS/openFDA)#

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