FDA.reportPublic FDA data

The Inkey List 360 Acne Clearing Serum

Manufacturer
Brand Evangelists for Beauty Limited | Orean Personal Care Ltd.
Effective date
2025-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:12

Label at a glance#

ProductThe Inkey List 360 Acne Clearing Serum
Active ingredientSALICYLIC ACID
Label structure8 sections

Indications and uses

for the treatment of acne.

Dosage and administration

Clean the skin thoroughly before applying this product.  Shake to activate. 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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne.

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.

Avoid contact with eyes.
If contact occurs, flush thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the skin thoroughly before applying this product. 
  • Shake to activate. 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

SPL UNCLASSIFIED SECTION

Avoid storing at extreme temperatures (below 40°F and above 100°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Coco-Caprylate/Caprate, Glycerin, Propanediol, Cetyl Alcohol, Panthenol, Arachidyl Alcohol, C10-18 Triglycerides, Distarch Phosphate, Zinc PCA, Octadecenedioic Acid, Dimethicone, Benzyl Alcohol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Potassium Cetyl Phosphate, Sodium Hydroxide, Behenyl Alcohol, Lactic Acid, Hydroxyacetophenone, Xanthan Gum, Arachidyl Glucoside, Sodium Lactate, Zinc Hydrolyzed Hyaluronate, Ethylhexylglycerin, Polysilicone-11, Sodium Hyaluronate, Tocopherol, Polylysine, Helianthus Annuus (Sunflower) Seed Oil.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free (833) 981-2335

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label CartonLabel CartonLabel PumpLabel Pump

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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81136-028-01The Inkey List 360 Acne Clearing Serum1 in 1 CARTONEMULSION11
81136-028-01The Inkey List 360 Acne Clearing Serum30 mL in 1 BOTTLE, PLASTICEMULSION301

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81136-02881136-028-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
CETYL ALCOHOL936JST6JCNIACT
PANTHENOLWV9CM0O67ZIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
ZINC PIDOLATEC32PQ86DH4IACT
OCTADECENEDIOIC ACID565ZMT5QRGIACT
DIMETHICONE92RU3N3Y1OIACT
BENZYL ALCOHOLLKG8494WBHIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
SODIUM HYDROXIDE55X04QC32IIACT
BEHENYL ALCOHOL9G1OE216XYIACT
LACTIC ACID33X04XA5ATIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
XANTHAN GUMTTV12P4NEEIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
SODIUM LACTATETU7HW0W0QTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM HYALURONATEYSE9PPT4THIACT
TOCOPHEROLR0ZB2556P8IACT
SUNFLOWER OIL3W1JG795YIIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
The Inkey List 360 Acne Clearing SerumSALICYLIC ACIDBrand Evangelists for Beauty Limitede5c0e866-4dd8-43d0-abaf-2e2351eb57c72025-07-25WarningsExact identifier
ndc (package): 81136-028-01
ndc (product): 81136-028
ndc11 (package): 81136002801
spl id: 3ac6688c-5b63-1cde-e063-6294a90a9306
spl set id: e5c0e866-4dd8-43d0-abaf-2e2351eb57c7

Reported adverse events (FAERS/openFDA)#

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