# SODIUM HYALURONATE (sodium-hyaluronate) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/sodium-hyaluronate - **Standard INCI**: `SODIUM HYALURONATE` - **KR MFDS Standard Name**: `소듐하이알루로네이트` - **CAS No.**: `9067-32-7` - **EC / EINECS No.**: `N/A` - **Origin**: `synthetic` - **Functions**: 보습제, 피부컨디셔닝제 - **Molecular Formula / MW**: `(C14H20NNaO11)n` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 소듐하이알루로네이트 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | SODIUM HYALURONATE | | US (PCPC / MoCRA INCI) | SODIUM HYALURONATE | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 透明质酸钠 | | JP (JCIA / MHLW QD) | ヒアルロン酸Ｎａ (QD: ヒアルロン酸ナトリウム（２）) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `6722`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 06578 (2025) - **cn_iecic_max** (rinse_off): ≤ 2% — NMPA IECIC (2025) Entry 06578 (2025) ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 4.5 – 7.5 - **Max Process Temp**: ≤ 70°C - **Synergy Pairings**: HYDROLYZED HYALURONIC ACID, SODIUM ACETYLATED HYALURONATE, PANTHENOL, GLYCERIN, CERAMIDE NP - **Incompatibilities**: High-MW (>1,000 kDa) powder above 0.3% causes severe film pilling/rolling upon drying; Precipitates with cationic surfactants; degrades under prolonged heating (>80°C) or extreme pH ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: SODIUM HYALURONATE | CAS No.: 9067-32-7 | EC No.: N/A - Origin: SYNTHETIC | Functions: , - Physicochemical Profile: Formula (C14H20NNaO11)n | MW /(Polymer/Complex) | / | Ionic Nature: anionic | PubChem CID 3084049 - Official Regional Label Names: US [SODIUM HYALURONATE] · EU [SODIUM HYALURONATE] · CN [透明质酸钠] · JP [ヒアルロン酸Ｎａ] · JP Quasi-Drug [ヒアルロン酸ナトリウム（２）] ■ [2. Dermatological Mechanism of Action & Functional Role] - SODIUM HYALURONATE functions primarily as , in dermatological and cosmetic formulations. Classified under origin 'synthetic', it acts within the cosmetic vehicle or stratum corneum to deliver , performance and structural formulation stability. ■ [3. Global 6-Jurisdiction Regulatory Status & Safety Limits (Layer 1 & Layer 2)] - Regional Summary: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 6722 (透明质酸钠)) - No specific Annex prohibition or numeric restriction across the 6 major jurisdictions (Permitted under general GMP safety assessment). - Official Safety & Historical Use Concentration (Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): Max 2.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 2.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.01 ~ 1.0% (Median 0.15%, Ref: CIR Hyaluronic Acid & Sodium Hyaluronate Assessment) — Biopolymer moisture-magnet & viscoelastic hydration film former - [emulsion_cream] Typical range: 0.01 ~ 0.5% (Median 0.1%, Ref: CIR Sodium Hyaluronate Reported Use) — Dermal moisture retention & barrier hydrator - [sun_color] Typical range: 0.02 ~ 0.1% (Median 0.05%, Ref: Global Starter Formulation Library Statistical Distribution (n=7, EVONIK 7)) — Sun care & color cosmetics dispersion / sensory modifier ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Water Phase (Slowly sprinkle powder onto vortex or pre-wet in Glycerin/BG; 1% stock solution added in Cool-down) - Optimal pH Range: pH 4.5 ~ 7.5 | Max Process Temp: Max 70°C | Electrolyte Tolerance: MEDIUM - Incompatibility / Caution: High-MW (>1,000 kDa) powder above 0.3% causes severe film pilling/rolling upon drying - Incompatibility / Caution: Precipitates with cationic surfactants; degrades under prolonged heating (>80°C) or extreme pH - Synergy Pairings: HYDROLYZED HYALURONIC ACID, SODIUM ACETYLATED HYALURONATE, PANTHENOL, GLYCERIN, CERAMIDE NP | Reference Trade Names: Hyacare®, Hymagic™-4D, Cristalhyal® ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42156326 (2026, J Cosmet Dermatol): Cross-Linked Sodium Hyaluronate Filler Containing Poly-L-Lactic Acid-b-Poly (Ethylene Glycol) Microspheres for Periorbit - PMID 42144152 (2026, Int J Biol Macromol): Sodium hyaluronate-based hydrogels with enhanced mechanical properties and anti-oxidant and anti-inflammatory characteri - PMID 42077373 (2026, Regen Biomater): A novel integrated in vitro method for evaluating the moisturizing performance of injectable sodium hyaluronate ## 6. Linked PubMed Literature - [PMID: 42156326] Cross-Linked Sodium Hyaluronate Filler Containing Poly-L-Lactic Acid-b-Poly (Ethylene Glycol) Microspheres for Periorbital Rejuvenation: A Multimodal Assessment of Physicochemical, Preclinical, and Clinical Performance. — *J Cosmet Dermatol* (2026) - [PMID: 42144152] Sodium hyaluronate-based hydrogels with enhanced mechanical properties and anti-oxidant and anti-inflammatory characteristics for wound healing — *Int J Biol Macromol* (2026) - [PMID: 42077373] A novel integrated in vitro method for evaluating the moisturizing performance of injectable sodium hyaluronate — *Regen Biomater* (2026) - [PMID: 42049428] PLLA and PDLLA Fillers: Linking Crystallinity and Mechanical Stability to Aggregation, Redispersion, and Collagen Formation — *In Vivo* (2026) - [PMID: 42028100] Efficacy and Safety of Picosecond Laser Combined With Sodium Hyaluronate for Melasma — *Plast Reconstr Surg Glob Open* (2026) - [PMID: 42214523] Hydroxyethyl cellulose as carbohydrate polymer scaffold for surfactant-free serums with enhanced hydration and structural stability. — *Int J Biol Macromol* (2026) - [PMID: 42296067] Diagnosis and Treatment of Thelazia callipaeda Infection: A Case Report — *J Vis Exp* (2026) - [PMID: 42188723] Utilization of Intracameral Viscoelastic Injection for the Management of Concurrent Choroidal and Retinal Detachment in a Glaucoma Patient — *Retin Cases Brief Rep* (2026) - [PMID: 42188310] Marine-Derived Neoagarotetraose Alleviates Dry Eye Disease by Suppressing Inflammation and Apoptosis in a Murine Model — *Mar Drugs* (2026) - [PMID: 42074812] Effects of Trehalose, Sodium Hyaluronate and N-Acetyl Aspartyl-Glutamic Acid Artificial Tears on Ocular Surface Parameters in Glaucoma Patients Receiving Preserved and Preservative-Free Prostaglandins — *J Clin Med* (2026) - [PMID: 37373443] Hyaluronic Acid: A Powerful Biomolecule with Wide-Ranging Applications-A Comprehensive Review — *Int J Mol Sci* (2023) - [PMID: 38931263] The Effects of Dietary Supplementation with Collagen and Vitamin C and Their Combination with Hyaluronic Acid on Skin Density, Texture and Other Parameters: A Randomised, Double-Blind, Placebo-Controlled Trial — *Nutrients* (2024) - [PMID: 30287361] Hyaluronic acid, a promising skin rejuvenating biomedicine: A review of recent updates and pre-clinical and clinical investigations on cosmetic and nutricosmetic effects — *Int J Biol Macromol* (2018) - [PMID: 36200921] Benefits of topical hyaluronic acid for skin quality and signs of skin aging: From literature review to clinical evidence — *Dermatol Ther* (2022) - [PMID: 32248707] Comparison of the effects of polynucleotide and hyaluronic acid fillers on periocular rejuvenation: a randomized, double-blind, split-face trial — *J Dermatolog Treat* (2022) - [PMID: 34361586] Advantages of Hyaluronic Acid and Its Combination with Other Bioactive Ingredients in Cosmeceuticals — *Molecules* (2021) - [PMID: 23467280] Hyaluronic acid: its function and distribution in the skin — *Dermato-Endocrinology* (2012) - [PMID: 35103348] Low-molecular-weight hyaluronic acid induces nucleus pulposus cell apoptosis and disc degeneration in vivo — *Journal of Orthopaedic Research* (2022)