# BUTYLPARABEN (butylparaben) — Global Cosmetic Regulatory & Formulation Monograph

- **Canonical URL**: https://www.inciname.com/en/ingredients/butylparaben
- **Standard INCI**: `BUTYLPARABEN`
- **KR MFDS Standard Name**: `부틸파라벤`
- **CAS No.**: `94-26-8`
- **EC / EINECS No.**: `202-318-7`
- **Origin**: `synthetic`
- **Functions**: 향료, 방부제
- **Molecular Formula / MW**: `—` (— g/mol)

## 1. 7-Track Official Regulatory Label Names
| Track | Official Label Nomenclature |
| :--- | :--- |
| KR (MFDS Standard) | 부틸파라벤 |
| KR (Former Names) | — |
| EU (CosIng 1223/2009) | BUTYLPARABEN |
| US (PCPC / MoCRA INCI) | BUTYLPARABEN |
| US (FDA OTC Monograph) | — |
| CN (NMPA IECIC) | 羟苯丁酯 |
| JP (JCIA / MHLW QD) | BUTYLPARABEN  |

## 2. Layer 1 — Global 6-Region Statutory Summary
- **KR (MFDS)**: `restricted`
- **EU (1223/2009)**: `restricted`
- **US (FDA/MoCRA)**: `none`
- **CN (NMPA IECIC)**: `allowed` (Entry: `5209`)
- **JP (MHLW)**: `none`
- **ASEAN (ACD)**: `none`

- **KR** [limited]: ≤ 0.8% —  (화장품 사용제한 원료 정보 (식약처 오픈API · 안전기준 [별표2]))
- **EU** [limited]: ≤ 0.14% —  (Regulation (EC) No 1223/2009 Annex V — via CosIng (EU Commission))

## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations
- **sccs_opinion** (all): ≤ 0.19% — undefined (undefined)
- **sccs_opinion** (all): ≤ 0.14% — undefined (undefined)

## 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: BUTYLPARABEN | CAS No.: 94-26-8 | EC No.: 202-318-7
  - Origin: SYNTHETIC | Functions: , 
  - Physicochemical Profile: Formula      | MW /(Polymer/Complex) | /   | Ionic Nature: non-ionic | CosIng/MFDS 
  - Official Regional Label Names: US [BUTYLPARABEN] · EU [BUTYLPARABEN] · CN [羟苯丁酯] · JP [-] · JP Quasi-Drug [-]
■ [2. Dermatological Mechanism of Action & Functional Role]
  - Butylparaben is the ester of butyl alcohol and p-hydroxybenzoic acid. It 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: RESTRICTED | EU: RESTRICTED | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (CN IECIC (2025) Entry No. 5209 (羟苯丁酯))
  - [KR / COMPOSITION / limited] (Max 0.8%): 
  - [EU / COMPOSITION / limited] (Max 0.14%): 
  - Official Safety & Historical Use Concentration (Layer 2): sccs (sccs_opinion, all): Max 0.19% / sccs (sccs_opinion, all): Max 0.14%
■ [4. Formulation Dosage Guide by Product Category (Layer 3-A)]
  - [cleanser_rinse] Typical range: 0.3 ~ 0.6% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=6, ELEMENTIS 6)) — Rinse-off cleanser & surfactant system modifier
  - [emulsion_cream] Typical range: 0.3 ~ 1.0% (Median 0.3%, Ref: Global Starter Formulation Library Statistical Distribution (n=5, ELEMENTIS 3 · SEPPIC 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: BUTYLPARABEN
■ [6. Peer-Reviewed Literature & Official Compendia Evidence]
  - PMID 42115332 (2026, Sci Rep): Spectrophotometric determination of butylparaben in cosmetics using dispersive solid-phase microextraction with newly sy
  - PMID 41762836 (2026, J Hazard Mater): Melatonin safeguards against butylparaben-induced oxidative stress, DNA damage, microtubule instability, and organelle d
  - PMID 39657861 (2025, Environ Pollut): Effects of long-term treatment with low concentration butylparaben on prostate organoids

## 6. Linked PubMed Literature
- [PMID: 42115332] Spectrophotometric determination of butylparaben in cosmetics using dispersive solid-phase microextraction with newly synthesized PHBpeg-CdS-1 — *Sci Rep* (2026)
- [PMID: 41762836] Melatonin safeguards against butylparaben-induced oxidative stress, DNA damage, microtubule instability, and organelle dysfunction during porcine oocyte maturation — *J Hazard Mater* (2026)
- [PMID: 39657861] Effects of long-term treatment with low concentration butylparaben on prostate organoids — *Environ Pollut* (2025)
- [PMID: 39424158] Toxic Beauty: Parabens and benzophenone-type UV Filters linked to increased non-alcoholic fatty liver disease risk — *Chemosphere* (2024)
- [PMID: 42156886] Biomonitoring of parabens in human milk and placenta and estimated daily intake in northern Taiwan — *J Expo Sci Environ Epidemiol* (2026)
- [PMID: 39624663] Isotherm and kinetic data for adsorption of butylparaben onto biochars derived from fique bagasse — *Data Brief* (2024)
- [PMID: 41886927] Maternal paraben exposure during early pregnancy is associated with altered cord blood DNA methylation: The PREDO cohort — *Environ Int* (2026)
- [PMID: 41644853] From shelf to stream: occurrence of parabens in personal care products and urban waters of La Plata, Argentina — *Environ Monit Assess* (2026)
- [PMID: 39955433] Young infants' exposure to parabens: lotion use as a potential source of exposure — *J Expo Sci Environ Epidemiol* (2025)
- [PMID: 39300872] Evaluation of dermal exposure to phthalates and parabens resulting from the use of hair relaxers — *Int J Environ Health Res* (2025)
- [PMID: 39181305] Association of phenol exposure during pregnancy and asthma development in children: The Japan Environment and Children's study — *Environ Pollut* (2024)
- [PMID: 39172001] Accumulation of Parabens, Their Metabolites, and Halogenated Byproducts in Migratory Birds of Prey: A Comparative Study in Texas and North Carolina, USA — *Environ Toxicol Chem* (2024)