# SALICYLIC ACID (salicylic-acid) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/salicylic-acid - **Standard INCI**: `SALICYLIC ACID` - **KR MFDS Standard Name**: `살리실릭애씨드` - **CAS No.**: `69-72-7` - **EC / EINECS No.**: `200-712-3` - **Origin**: `synthetic` - **Functions**: 피지억제제, 모발컨디셔닝제, 각질제거제, 향료, 방부제, 피부컨디셔닝제 - **Molecular Formula / MW**: `C7H6O3` (138.12 g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 살리실릭애씨드 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | SALICYLIC ACID | | US (PCPC / MoCRA INCI) | SALICYLIC ACID | | US (FDA OTC Monograph) | SALICYLIC ACID | | CN (NMPA IECIC) | 水杨酸 | | JP (JCIA / MHLW QD) | サリチル酸 (QD: サリチル酸) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `restricted` - **EU (1223/2009)**: `restricted` - **US (FDA/MoCRA)**: `restricted` - **CN (NMPA IECIC)**: `restricted` (Entry: `6405`) - **JP (MHLW)**: `restricted` - **ASEAN (ACD)**: `restricted` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **sccs_opinion** (all): ≤ 0.5% — undefined (undefined) - **sccs_opinion** (rinse_off): ≤ 3% — undefined (undefined) - **sccs_opinion** (leave_on): ≤ 2% — undefined (undefined) - **sccs_opinion** (leave_on): ≤ 0.1% — undefined (undefined) - **sccs_opinion** (toothpaste): ≤ 0.5% — undefined (undefined) - **reported_use** (rinse_off): ≤ 3% — undefined (undefined) - **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 06235 (2025) - **cn_iecic_max** (rinse_off): ≤ 3% — NMPA IECIC (2025) Entry 06235 (2025) ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 3.5 – 4.8 - **Max Process Temp**: ≤ 75°C - **Synergy Pairings**: BETAINE, PROPANEDIOL, NIACINAMIDE, ZINC PCA, POLYACRYLATE CROSSPOLYMER-6 - **Incompatibilities**: CRITICAL RECRYSTALLIZATION HAZARD: Cold-water solubility is only ~0.2%; precipitates as sharp white needle crystals above 0.2% unless co-solubilized with Propanediol/Butylene Glycol (15~25%) + Betaine or Cyclodextrin! Forms purple complex with trace Fe3+ (requires EDTA/Sodium Phytate) and collapses Carbomer ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: SALICYLIC ACID | CAS No.: 69-72-7 | EC No.: 200-712-3 - Origin: SYNTHETIC | Functions: , , , , , - Physicochemical Profile: Formula C7H6O3 | MW 138.12 g/mol | LogP 2.26 | Ionic Nature: anionic | PubChem CID 338 - Official Regional Label Names: US [SALICYLIC ACID] · EU [SALICYLIC ACID] · CN [水杨酸] · JP [サリチル酸] · JP Quasi-Drug [サリチル酸] ■ [2. Dermatological Mechanism of Action & Functional Role] - Lipophilic beta-hydroxy acid (BHA, LogP 2.26) capable of partitioning into sebum-filled follicles. Exerts keratolytic and comedolytic action by dissolving intercellular corneodesmosomal junctions while providing bacteriostatic and anti-inflammatory benefits. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: RESTRICTED | EU: RESTRICTED | US: RESTRICTED | CN: RESTRICTED | JP: RESTRICTED | ASEAN: RESTRICTED (CN IECIC (2025) Entry No. 6405 (水杨酸)) - [EU / COMPOSITION / limited] (Max 2%): - [US / COMPOSITION / limited] (Max 2%): - [CN / COMPOSITION / limited] (Max 2%): - [JP / COMPOSITION / limited] (Max 0.2%): - Official Safety & Historical Use Concentration (Layer 2): sccs (sccs_opinion, all): Max 0.5% / sccs (sccs_opinion, rinse_off): Max 3% / sccs (sccs_opinion, leave_on): Max 2% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [cleanser_rinse] Typical range: 0.5 ~ 2.0% (Median 1.0%, Ref: SCCS/1601/18 Opinion, KR MFDS Annex 2/4 & US FDA OTC Acne Monograph) — Lipophilic Beta-Hydroxy Acid (BHA) comedolytic & keratolytic active (KR/US/EU max 2.0%) - [aqueous_serum] Typical range: 0.1 ~ 2.0% (Median 0.5%, Ref: EU Annex III #98 & KR MFDS Annex 2) — Pore-clearing BHA serum & toner active (KR leave-on max 0.5%; EU/US max 2.0%) ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Co-solvent Phase (Pre-dissolve in 15~25% Propanediol/Butylene Glycol + Polyglyceryl-10 Laurate or neutralize partially with Arginine/Sodium Citrate/Betaine) - Optimal pH Range: pH 3.5 ~ 4.8 | Max Process Temp: Max 75°C | Electrolyte Tolerance: NONE - Incompatibility / Caution: CRITICAL RECRYSTALLIZATION HAZARD: Cold-water solubility is only ~0.2%; precipitates as sharp white needle crystals above 0.2% unless co-solubilized with Propanediol/Butylene Glycol (15~25%) + Betaine or Cyclodextrin! Forms purple complex with trace Fe3+ (requires EDTA/Sodium Phytate) and collapses Carbomer - Synergy Pairings: BETAINE, PROPANEDIOL, NIACINAMIDE, ZINC PCA, POLYACRYLATE CROSSPOLYMER-6 | Reference Trade Names: Salicylic Acid USP, BioGenic Sali-210 (Encapsulated) ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 32356369 (2020, Cochrane Database Syst Rev): Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne - PMID 40682377 (2025, J Cosmet Dermatol): Clinical Efficacy of a Salicylic Acid-Containing Gel on Acne Management and Skin Barrier Function: A 21-Day Prospective - PMID 12218932 (2002, Ann Dermatol Venereol): [Salicylic acid as a keratolytic agent] ## 6. Linked PubMed Literature - [PMID: 32356369] Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne — *Cochrane Database Syst Rev* (2020) - [PMID: 40682377] Clinical Efficacy of a Salicylic Acid-Containing Gel on Acne Management and Skin Barrier Function: A 21-Day Prospective Study — *J Cosmet Dermatol* (2025) - [PMID: 12218932] [Salicylic acid as a keratolytic agent] — *Ann Dermatol Venereol* (2002) - [PMID: 39968706] 30% Supramolecular Salicylic Acid Improved Symptoms and Skin Barrier in Papulopustular Rosacea — *J Cosmet Dermatol* (2025) - [PMID: 42306365] Chemical Peels in Skin of Color: A Scoping Review of Safety, Efficacy, and Practice Patterns. — *Cureus* (2026) - [PMID: 42292717] Systemic Salicylate Toxicity From Topical Emollient Use in an Infant With Suspected Ichthyosis. — *Cureus* (2026) - [PMID: 42250712] Combination therapy using Ciclopirox and Salicylic acid incorporated Chitosan lotion for onychomycosis treatment — *Int J Biol Macromol* (2026) - [PMID: 42235053] A Novel Retinoid and Salicylic Acid Topical Treatment for Moderate-Severe Acne — *J Drugs Dermatol* (2026) - [PMID: 42235049] Randomized Controlled Study of Bacteriophages in Acne Reveals Efficacy and Novel Mechanism for Promoting Long-Term Skin Health — *J Drugs Dermatol* (2026) - [PMID: 42225329] Topicals for Psoriasis: Classical Drugs, New Concepts, and New Medications — *J Rheumatol* (2026) - [PMID: 42087526] International Expert Consensus on Integrated Skincare Active Ingredients for Pretreatment and Posttreatment Use With Medical Aesthetic Procedures to Enhance Skin Benefits — *J Cosmet Dermatol* (2026) - [PMID: 42025657] Tailored dual release of retinol and salicylic acid from salicylate-based poly(anhydride-ester) microspheres with tunable degradation profiles — *Int J Pharm* (2026) - [PMID: 42016197] Resistant Facial Verruca Plana Treated with a Single-Dose Intramuscular Hepatitis B Vaccine as Immunotherapy in a Child — *Int Med Case Rep J* (2026) - [PMID: 42007752] Enhanced Home-Based Wart Treatment Protocol: Optimizing Debridement and Occlusion Therapy for Improved Outcomes — *Adv Skin Wound Care* (2026) - [PMID: 26347269] Salicylic acid as a peeling agent: a comprehensive review — *Clin Cosmet Investig Dermatol* (2015) - [PMID: 42264092] Assessment of the Efficacy and Safety of 50% Glycolic Acid, 30% Salicylic Acid, and Modified Jessner's Chemical Peels in the Treatment of Active Acne and Post-acne Hyperpigmentation: Randomized Controlled Trial — *J Am Acad Dermatol* (2026) - [PMID: 29999734] Salicylic Acid — ** (2006) - [PMID: ] PubChem Compound Summary: Salicylic Acid — *PubChem Compound Database* (2026)