# GLUTATHIONE (glutathione) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/glutathione - **Standard INCI**: `GLUTATHIONE` - **KR MFDS Standard Name**: `글루타티온` - **CAS No.**: `70-18-8` - **EC / EINECS No.**: `200-725-4` - **Origin**: `peptide` - **Functions**: 환원제 - **Molecular Formula / MW**: `C10H17N3O6S` (307.32 g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 글루타티온 | | KR (Former Names) | 글루타치온 | | EU (CosIng 1223/2009) | GLUTATHIONE | | US (PCPC / MoCRA INCI) | GLUTATHIONE | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 谷胱甘肽 | | JP (JCIA / MHLW QD) | グルタチオン (QD: グルタチオン) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `2586`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 02521 (2025) - **cn_iecic_max** (rinse_off): ≤ 1% — NMPA IECIC (2025) Entry 02521 (2025) ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 4.5 – 6 - **Max Process Temp**: ≤ 40°C - **Synergy Pairings**: 3-O-ETHYL ASCORBIC ACID, NIACINAMIDE, TRANEXAMIC ACID, HYDROGENATED LECITHIN, FERULIC ACID - **Incompatibilities**: MAJOR FORMULATION CHALLENGE: Free thiol (-SH) group oxidizes in aqueous solution, releasing foul rotten-egg hydrogen sulfide (H2S) odor and losing potency! Mitigate via Hydrogenated Lecithin liposomal encapsulation, Cyclodextrin complexation, or S-Acetyl Glutathione + 3-O-Ethyl Ascorbic Acid + Sodium Metabisulfite ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: GLUTATHIONE | CAS No.: 70-18-8 | EC No.: 200-725-4 - Origin: PEPTIDE | Functions: - Physicochemical Profile: Formula C10H17N3O6S | MW 307.32 g/mol | LogP -4.5 | Ionic Nature: anionic | PubChem CID 124886 - Official Regional Label Names: US [GLUTATHIONE] · EU [GLUTATHIONE] · CN [谷胱甘肽] · JP [グルタチオン] · JP Quasi-Drug [グルタチオン] ■ [2. Dermatological Mechanism of Action & Functional Role] - Endogenous tripeptide antioxidant bearing a redox-active sulfhydryl (-SH) moiety. Directly inhibits tyrosinase via copper chelation and conjugates with dopaquinone to shift melanogenesis from dark eumelanin toward light phaeomelanin. ■ [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. 2586 (谷胱甘肽)) - 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 1.0% ■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)] - [aqueous_serum] Typical range: 0.05 ~ 2.0% (Median 0.5%, Ref: PubMed Topical Glutathione Melanin Index RCTs & CN IECIC) — Master endogenous antioxidant tripeptide shifting eumelanogenesis to phaeomelanin - [emulsion_cream] Typical range: 0.05 ~ 1.0% (Median 0.3%, Ref: PubMed Glutathione Clinical Studies & CN IECIC) — Liposomal brightening & antioxidant toning cream active ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Final Cool-down Phase (< 35°C; Liposomal encapsulation or Cyclodextrin complexation strongly required) - Optimal pH Range: pH 4.5 ~ 6.0 | Max Process Temp: Max 40°C | Electrolyte Tolerance: NONE - Incompatibility / Caution: MAJOR FORMULATION CHALLENGE: Free thiol (-SH) group oxidizes in aqueous solution, releasing foul rotten-egg hydrogen sulfide (H2S) odor and losing potency! Mitigate via Hydrogenated Lecithin liposomal encapsulation, Cyclodextrin complexation, or S-Acetyl Glutathione + 3-O-Ethyl Ascorbic Acid + Sodium Metabisulfite - Synergy Pairings: 3-O-ETHYL ASCORBIC ACID, NIACINAMIDE, TRANEXAMIC ACID, HYDROGENATED LECITHIN, FERULIC ACID | Reference Trade Names: Setria® Glutathione (Kyowa Hakko), Liposomal GSH ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 42270691 (2026, Sci Rep): Protective effects of rutin and quercetin against diazinon-induced toxicity in Wistar Rat Liver - PMID 42313915 (2026, FASEB J): Exercise Training Stimulates the Release of Glutathione Peroxidase 1 (GPX1)-Enriched Extracellular Vesicles That Promote - PMID 42312160 (2026, ACS Pharmacol Transl Sci): Unveiling the Role of Glutathione S‑transferase Protein in Breast Cancer Drug Resistance: Insights into the Signaling Pa ## 6. Linked PubMed Literature - [PMID: 42270691] Protective effects of rutin and quercetin against diazinon-induced toxicity in Wistar Rat Liver — *Sci Rep* (2026) - [PMID: 42313915] Exercise Training Stimulates the Release of Glutathione Peroxidase 1 (GPX1)-Enriched Extracellular Vesicles That Promote Angiogenesis — *FASEB J* (2026) - [PMID: 42312160] Unveiling the Role of Glutathione S‑transferase Protein in Breast Cancer Drug Resistance: Insights into the Signaling Pathways and Therapeutic Implications — *ACS Pharmacol Transl Sci* (2026) - [PMID: 42306466] Pink lotus flower (Nelumbo nucifera) oil extract alleviates imiquimod-induced psoriasis-like dermatitis — *Biomed Rep* (2026) - [PMID: 42304549] Resistance monitoring and putative biochemical mechanisms of Spodoptera frugiperda to different insecticides in China — *Pest Manag Sci* (2026) - [PMID: 42300970] MXene-based protective strategy for diabetic gingival wound healing: shielding fibroblasts from oxidative stress — *J Mater Chem B* (2026) - [PMID: 42296001] Ti(3)C(2)T(x) MXene Nanosheets: Bridging High-Performance Energy Storage and Comprehensive In Vivo Biocompatibility Assessment — *ACS Appl Mater Interfaces* (2026) - [PMID: 42295518] Effect of zinc oxide nanoparticle supplementation in Santa Inês ewes during the transition period — *Trop Anim Health Prod* (2026) - [PMID: 42278195] Beyond Inflammation: The Role of Oxidative Stress and Gut-Skin Axis Dysbiosis in the Pathogenesis of Immune-Mediated Skin Disorders and Potential Therapeutic Implications — *Int J Mol Sci* (2026) - [PMID: 42274816] Algal Derived Bioactive Compounds as Radiation Protectant: An Emerging Strategy for Future Applications — *Curr Microbiol* (2026) - [PMID: 42271386] Dual-responsive polypyridyl Ru(II)-scaffolded hydrogel for trinitarian tumor therapy activated by mono-wavelength photo-irradiation — *J Nanobiotechnology* (2026) - [PMID: 42271005] Preparation, characterization and in-vivo evaluation of nanoemulsion based hydrogel of ferulic acid in imiquimod-induced psoriasis in rats — *Sci Rep* (2026)