# CAFFEINE (caffeine) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/caffeine
- **Standard INCI**: `CAFFEINE`
- **KR MFDS Standard Name**: `카페인`
- **CAS No.**: `58-08-2`
- **EC / EINECS No.**: `200-362-1`
- **Origin**: `synthetic`
- **Functions**: 피부컨디셔닝제, 향료
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 카페인 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | CAFFEINE |
| US (PCPC / MoCRA INCI) | CAFFEINE |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 咖啡因 |
| JP (JCIA / MHLW QD) | カフェイン (QD: 無水カフェイン) |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `none`
- **EU (1223/2009)**: `none`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `4077`)
- **JP (MHLW)**: `restricted`
- **ASEAN (ACD)**: `none`

- **JP** [limited]: ≤ 2% —  (化粧品に配合可能な医薬品の成分について(薬食審査発第0524001号) 별첨 「承認化粧品成分の範囲」)

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- Listed within general cosmetic GMP safety thresholds.

## 4. Layer 3 — Formulation Quartiles & Compatibility
- **Optimal pH Window**: 4 – 8
- **Max Process Temp**: ≤ 50°C
- **Synergy Pairings**: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL
- **Incompatibilities**: Verify phase compatibility under extreme pH or high electrolyte loads

## 5. Academic Monograph
■ [1. Chemical Identity & International Labeling Nomenclature]
  - INCI Name: CAFFEINE | CAS No.: 58-08-2 | EC No.: 200-362-1
  - Origin: SYNTHETIC | Functions: Skin Conditioning, 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [CAFFEINE] · EU [CAFFEINE] · CN [咖啡因] · JP [カフェイン] · JP Quasi-Drug [無水カフェイン]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Caffeine is the heterocyclic organic compound 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: RESTRICTED | ASEAN: NONE (CN IECIC (2025) Entry No. 4077 (咖啡因))
  - [JP / COMPOSITION / limited] (Max 2%): 
  - Official Safety & Historical Use Concentration (Layer 2): Quantum satis (QS) within standard cosmetic safety margins
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [emulsion_cream] Typical range: 0.1 ~ 1.0% (Median 1.0%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, GRANT 3 · EVONIK 2)) — Emulsion cream & lotion structural / conditioning agent
■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)]
  - Addition Phase: Water Phase or Cool-down Phase (< 45°C)
  - Optimal pH Range: pH 4.0 ~ 8.0 | Max Process Temp: Max 50°C | Electrolyte Tolerance: MEDIUM
  - Incompatibility / Caution: Verify phase compatibility under extreme pH or high electrolyte loads
  - Synergy Pairings: GLYCERIN, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL | Reference Trade Names: CAFFEINE
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 23075568 (2013, Skin Pharmacol Physiol): Caffeine's mechanisms of action and its cosmetic use
  - PMID 40820949 (2025, J Cosmet Dermatol): A Novel Approach Against Male Pattern Hair Loss With Topical Dimethylglycine Sodium Salt (DMG-Na) and Caffeine: Efficacy
  - PMID 26004004 (2015, Int J Pharm): Topical and transdermal delivery of caffeine

## 6. Linked PubMed Literature
- [PMID: 23075568] Caffeine's mechanisms of action and its cosmetic use — *Skin Pharmacol Physiol* (2013)
- [PMID: 40820949] A Novel Approach Against Male Pattern Hair Loss With Topical Dimethylglycine Sodium Salt (DMG-Na) and Caffeine: Efficacy of a 24-Week, Double-Blind, Randomized, Placebo-Controlled Trial — *J Cosmet Dermatol* (2025)
- [PMID: 26004004] Topical and transdermal delivery of caffeine — *Int J Pharm* (2015)
- [PMID: 32599587] Caffeine and Its Pharmacological Benefits in the Management of Androgenetic Alopecia: A Review — *Skin Pharmacol Physiol* (2020)
- [PMID: 34105652] Challenges of nanotechnology in cosmetic permeation with caffeine — *Braz J Biol* (2021)
- [PMID: 18179623] Effect of caffeine on UVB-induced carcinogenesis, apoptosis, and the elimination of UVB-induced patches of p53 mutant epidermal cells in SKH-1 mice — *Photochem Photobiol* (2008)
- [PMID: 42196973] Differential Time-of-Day Effects of Caffeine Capsule and Mouth Rinse on Physical Performance and Volleyball-Specific Skills in Adolescent Male Volleyball Players — *Nutrients* (2026)
- [PMID: 41901129] Effects of Caffeine Ingestion on Morning Cognitive and Muscle Strength Measures in Males: A Standardized Approach — *Nutrients* (2026)
- [PMID: 41791366] High-Intensity Intermittent Exercise and Mouth Rinsing: A Systematic Review and Meta-Analysis — *Int J Sport Nutr Exerc Metab* (2026)
- [PMID: 41774525] Revisiting the evidence on caffeine mouth rinse: effects on exercise and cognitive performance: a meta-analytic review — *J Int Soc Sports Nutr* (2026)
- [PMID: 41754894] Clinical Effectiveness of a Novel Caffeine Nano-Cream for Cellulite Reduction: A Randomised Double-Blind Trial — *Pharmaceutics* (2026)
- [PMID: 41754174] Comparing Acute Effects of Caffeine Delivery Forms on Cross-Training Performance: A Randomized Placebo-Controlled Crossover Trial — *Nutrients* (2026)
- [PMID: 42131805] Green tea-derived exosome-like nanoparticles attenuate oxidative stress-induced skin senescence via modulation of p38 MAPK signaling — *Front Pharmacol* (2026)
- [PMID: 42123662] Vasorelaxing Effect of Hydrolyzed Collagen from Salmon Skin in the Thoracic Aorta and Underlying Mechanisms — *Int J Mol Sci* (2026)
- [PMID: 42040972] Efficient aqueous solubilization of methylxanthines via complexation with natural polyphenolate salts — *RSC Adv* (2026)
- [PMID: 41985610] Spatial occurrence and distribution of micropollutants (pharmaceuticals and personal care products) in the eThekwini catchment, South Africa — *Environ Pollut* (2026)
- [PMID: 41965162] Ecotoxicological assessment of Zantedeschia aethiopica (L.) and Eisenia foetida Savigny exposure to pharmaceutical and personal care products, and hazelnut shell — *Sci Total Environ* (2026)
- [PMID: 41785591] Occurrence and ecological risk of pharmaceuticals and personal care products in Djibouti's coastal waters — *Mar Pollut Bull* (2026)