# BETAINE (betaine) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/betaine
- **Standard INCI**: `BETAINE`
- **KR MFDS Standard Name**: `베타인`
- **CAS No.**: `107-43-7`
- **EC / EINECS No.**: `203-490-6`
- **Origin**: `synthetic`
- **Functions**: 대전방지제, 모발컨디셔닝제, 보습제, 피부컨디셔닝제, 점도조절제
- **Molecular Formula / MW**: `C5H11NO2` (117.15 g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 베타인 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | BETAINE |
| US (PCPC / MoCRA INCI) | BETAINE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 甜菜碱 |
| JP (JCIA / MHLW QD) | ベタイン (QD: トリメチルグリシン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `6665`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`



## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **cn_iecic_max** (leave_on): ≤ 20% — NMPA IECIC (2025) Entry 06478 (2025)
- **cn_iecic_max** (rinse_off): ≤ 16% — NMPA IECIC (2025) Entry 06478 (2025)

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 3 – 10
- **Max Process Temp**: ≤ 85°C
- **Synergy Pairings**: GLYCERIN, SALICYLIC ACID, ALLANTOIN, ECTOIN
- **Incompatibilities**: Zwitterionic osmolyte that enhances water solubility of Salicylic Acid and Allantoin while reducing Glycerin tackiness

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: BETAINE | CAS No.: 107-43-7 | EC No.: 203-490-6
  - Origin: SYNTHETIC | Functions: , , , , 
  - Physicochemical Profile: Formula C5H11NO2 | MW 117.15 g/mol | LogP -3.1 | Ionic Nature: amphoteric | PubChem CID 247
  - Official Regional Label Names: US [BETAINE] · EU [BETAINE] · CN [甜菜碱] · JP [ベタイン] · JP Quasi-Drug [トリメチルグリシン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Betaine is the zwitterion (inner salt) that conforms to the formula 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. 6665 (甜菜碱))
  - 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 20.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): Max 16.0%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [aqueous_serum] Typical range: 0.5 ~ 5.0% (Median 2.0%, Ref: IFF/Genencare OSMS BA TDS & CIR Assessment) — Sugar-beet derived osmolyte humectant & tackiness reducer
  - [cleanser_rinse] Typical range: 0.5 ~ 5.0% (Median 2.0%, Ref: Genencare OSMS BA Technical Dossier) — Surfactant irritation mitigant & barrier protectant
  - [emulsion_cream] Typical range: 1.0 ~ 5.0% (Median 2.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=26, EVONIK 26)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase
  - Optimal pH Range: pH 3.0 ~ 10.0 | Max Process Temp: Max 85°C | Electrolyte Tolerance: HIGH
  - Incompatibility / Caution: Zwitterionic osmolyte that enhances water solubility of Salicylic Acid and Allantoin while reducing Glycerin tackiness
  - Synergy Pairings: GLYCERIN, SALICYLIC ACID, ALLANTOIN, ECTOIN | Reference Trade Names: Genencare® OSMS BA, TEGO® Natural Betaine
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42202650 (2026, Biomater Adv): DES-mediated self-assembled polypeptides: Synergistic neuromuscular signaling inhibition for anti-aging
  - PMID 42000464 (2026, Colloids Surf B Biointerfaces): A hydrogel dressing derived from furoic acid/betaine co-modified chitosan: accelerating Staphylococcus aureus -infected 
  - PMID 41995401 (2026, J Mater Chem B): A natural deep eutectic solvent formulation promotes hair growth by enhancing the transdermal delivery and bioactivity o

## 6. Linked PubMed Literature
- [PMID: 42202650] DES-mediated self-assembled polypeptides: Synergistic neuromuscular signaling inhibition for anti-aging — *Biomater Adv* (2026)
- [PMID: 42000464] A hydrogel dressing derived from furoic acid/betaine co-modified chitosan: accelerating Staphylococcus aureus -infected wound healing — *Colloids Surf B Biointerfaces* (2026)
- [PMID: 41995401] A natural deep eutectic solvent formulation promotes hair growth by enhancing the transdermal delivery and bioactivity of hydroxytyrosol — *J Mater Chem B* (2026)
- [PMID: 41610079] A Supramolecular Salicylic Acid-Betaine with Superior Epidermal Benefits and Better Tolerance: In vitro Proof of Concept Studies — *Skin Pharmacol Physiol* (2026)
- [PMID: 41750951] Dietary Sources of Glycine Betaine and Proline Betaine in Plant Foods and Their Potential Biological Relevance in Human Nutrition — *Foods* (2026)
- [PMID: 41606489] Biosynthesized ZnO nanoparticles enhance salt tolerance in Brassica Napus through antioxidant and gene regulatory pathways — *BMC Plant Biol* (2026)
- [PMID: 42269409] Multifunctional polyacrylamide-gelatin deep eutectic gel with integrated antibacterial, antifreezing, and conductive properties for wearable motion sensing — *Talanta* (2026)
- [PMID: 42237409] Multi-omics characterization of the skin microbiota reveals the anti-aging roles of Stenotrophomonas maltophilia — *Microbiome* (2026)
- [PMID: 41831283] Screening natural deep eutectic solvent-based extraction to analyze illegal skin-whitening ingredients in cosmetics using HPLC and LC-MS/MS — *J Chromatogr B Analyt Technol Biomed Life Sci* (2026)
- [PMID: 41685624] Preservative Kinetics and Influence of Surfactants on Gram-Negative Bacterial Membrane Partitioning — *Langmuir* (2026)
- [PMID: 41658751] Oryza Ceramax in Dermatologic Care: A Multi-pathway Approach to Skin Hydration and Barrier Repair — *Cureus* (2026)
- [PMID: 41649178] Patterns of Sensitization and Cross-Reactivity in Hair Dye Allergy: An 18-Year Tertiary-Center Experience from Greece — *Dermatitis* (2026)