원료 사전 탐색/dimethicone/DIMETHICONE
Tier 1 Monograph · SSOT 15 FieldsRaw .md (GEO) ↗
합성 (Synthetic)

DIMETHICONE

식약처 한글 표준명: 다이메티콘
피부컨디셔닝제피부보호제소포제에모리엔트
[식약처 공정서 기원 및 정의] 이 원료는 트라이메틸셀록시 단위로 끝이 막힌 완전 메틸화된 선형 실록세인 중합체 혼합물이다.
결론 선행 Executive Regulatory & Safety Fact BoxAEO / GEO CITATION ANCHOR

화장품에서 다이메티콘 (DIMETHICONE)의 글로벌 배합 한도와 핵심 효능·처방 기준은 무엇인가요?

다이메티콘(표준 INCI: DIMETHICONE, CAS 번호: 63148-62-9)은 화장품 처방에서 주로 피부컨디셔닝제, 피부보호제, 소포제 목적으로 배합되는 핵심 원료입니다. 한국 식약처(미규제) 및 유럽 CosIng(미규제) 등 6대 권역 법정 기준 하에 관리되며, 통상 0.5–10%(적정 pH 2–12) 범위에서 안정적으로 처방됩니다.

7대 갈래 국가별·용도별 공식 전성분 라벨 표기명 매트릭스

각국 1차 법원 고시 정본 · 기계번역·임의 음차 0건
7-Track Official Statutory Label Names for DIMETHICONE
국가·규제 트랙공식 고시 전성분 표기명원클릭 복사
① 한국 (MFDS 화장품 한글 표준명)다이메티콘
② 한국 구명칭 (개정 전 이력 · 301 리다이렉트)디메치콘
③ 유럽 (EU CosIng EC 1223/2009)DIMETHICONE
④ 미국 일반화장품 (US PCPC / MoCRA INCI)DIMETHICONE
⑤ 미국 OTC (FDA Active Ingredient Monograph)DIMETHICONE
⑥ 중국 (NMPA IECIC 표준 중문명)聚二甲基硅氧烷
⑦ 일본 일반화장품 / 의약부외품 (JCIA / MHLW)ジメチコン · [QD: メチルポリシロキサン]

Layer 1 — 글로벌 6대 권역 법정 배합 한도 및 규제 상태

Layer 1 Statutory Regulatory Limits Across 6 Regions for DIMETHICONE
권역규제 상태배합 한도제한 조건 및 1차 법원 출처
한국 (MFDS)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
유럽 (CosIng)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
미국 (FDA/CIR)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
중국 (NMPA)등재·허용GMPIECIC Entry #3732
일본 (MHLW)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)
아세안 (ACD)미규제GMP공식 화장품 원료 목록 등재 (GMP 기준 사용)

Layer 2 — 독성·안전성 평가 한도 (US CIR · EU SCCS MoS≥100 · CN IECIC 최고역사사용량)

「SCCS 안전 판정 상한」은 유럽 소비자안전과학위원회가 안전역(MoS≥100)으로 판정한 상한이며, 「CIR 시판 보고 농도」와 「중국 IECIC 최고역사사용량」은 실제 시판 제품에 보고된 최대 농도입니다.

Layer 2 Toxicological & Historical Safe Use Concentrations for DIMETHICONE
안전성 평가 기준적용 부위·유형안전 농도 범위판정 결과 및 문헌 번호
중국 IECIC 최고역사사용량leave_on≤ 85%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03477 (2025)
중국 IECIC 최고역사사용량rinse_off≤ 30%안전 판정(MoS≥100)NMPA IECIC (2025) Entry 03477 (2025)
⚠️ 참조용 안내 (법적 면책 공지): 이 사전의 성분명·규제 한도·배합 가이드는 연구·개발 참조용으로만 제공됩니다. 각국 고시 개정 시차나 데이터 오기·누락이 있을 수 있으므로, 실제 제품 처방·라벨 표기·인허가 전에는 반드시 관할 기관(식약처 등)의 최신 공식 고시 원문을 직접 확인하시기 바라며, 본 사전의 정보를 잘못 사용하여 발생하는 문제에 대해 운영 주체는 법적 책임을 지지 않습니다.
제형군별 사분위수(Min–Q1–Median–Q3–Max) 분포 그래프

Layer 3 제형군별 통상 배합 농도(%) 레인지 & Layer 1 법정 한도 대조

O/W · W/O 에멀전·크림n=286
Min 0.5% · Q1 1% · Median 2% · Q3 4% · Max 10%
자외선차단·색조n=134
Min 1% · Q1 3% · Median 5% · Q3 10% · Max 20%
무수 오일·밤n=8
Min 0.5% · Q1 4.5% · Median 7.5% · Q3 20.1875% · Max 65%
수성 토너·세럼·앰플n=45
Min 0.1% · Q1 1.5% · Median 3% · Q3 10% · Max 48%
세정 폼·샴푸 (린스오프)n=5
Min 0.5% · Q1 0.5% · Median 1% · Q3 1.5% · Max 2%
O/W · W/O 에멀전·크림 — 유화 백탁(Soaping) 즉시 제거, 실키한 발림성 및 통기성 보호막 형성
공식 검증 원천: Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment (cir_safety) · Dow 142 · Grant 84 · Evonik 60
권장 중앙값: 2%

Layer 3 — 제형군별 통상 배합 농도(n≥5 사분위수) & 물리화학·상용성 가이드

Layer 3 Formulation Concentration Quartiles by Product Category for DIMETHICONE
제형군 분류Min – Q1 – Median – Q3 – Max (%)처방 역할 및 기전Source ID
제형군 B — 유화 로션 · 에멀전 · 크림 (O/W · W/O)0.5% · 1% · 2% · 4% · 10%유화 백탁(Soaping) 즉시 제거, 실키한 발림성 및 통기성 보호막 형성Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment
제형군 D — 자외선차단제(선크림) · 색조 · 파운데이션1% · 3% · 5% · 10% · 20%선크림·프라이머 발수성 및 매끄러운 피니시 부여US FDA OTC Skin Protectant Monograph (1~30%) & CIR
제형군 E — 무수 오일 · 멀티밤 · 립케어0.5% · 4.5% · 7.5% · 20.1875% · 65%무수 밤·스틱·오일 처방 유상 골격 및 보습막 형성Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · ELEMENTIS 2 · EVONIK 1)
제형군 A — 수성 토너 · 세럼 · 고농축 앰플0.1% · 1.5% · 3% · 10% · 48%수성 세럼·토너·하이드로겔 처방 베이스 및 기능성 부여Global Starter Formulation Library Statistical Distribution (n=45, GRANT 26 · SEPPIC 9 · EVONIK 7 · ELEMENTIS 3)
제형군 C — 세정 워시오프 · 폼 · 샴푸 · 바디워시0.5% · 0.5% · 1% · 1.5% · 2%린스오프 세정·클렌징 처방 계면 안정화 및 사용감 개선Global Starter Formulation Library Statistical Distribution (n=5, SEPPIC 3 · GRANT 2)
피부 투과 과학 시각화 (Bos & Meinardi 500 Dalton Rule)MW: Macro/Complex · LogP: N/A

각질층 장벽 투과 깊이 & 바이오 스피큘 경피전달(DDS) 시뮬레이션

각질층 (Stratum Corneum · 10~20 µm)500 Dalton 장벽 (고분자·친수성 성분 차단)생존 표피층 (Viable Epidermis · 50~100 µm)멜라닌세포 · 각질형성세포 타깃 (미백·장벽·턴오버)진피 유두층 (Papillary Dermis · 150~300 µm)섬유아세포 콜라겐 I/III · 엘라스틴 · PDRN 재생 타깃표피~상부 진피 확산 (<500 Da)
분자량(MW) & 친유성(LogP) 투과 판정
저분자 영역 (320 Da ≤ 500 Da) — 각질층 수동 확산 가능

단독 도포 시 각질층 세포간 지질(Brick & Mortar) 경로를 통해 확산됩니다. 500 Dalton 이상 친수성 분자는 각질층 표면에 주로 머물러 보습·보호막 역할을 수행합니다.

예상 도달 깊이
40–90 µm
권장 전달 시스템
Polyol Enhancer / Serum
계면화학 · pH · 열역학 공정 시각화

pH 안정성 스펙트럼(0~14) · 가열 한계 게이지 · HLB 콜로이드 상거동

Soluble in silicones and light alkanes; insoluble in water and polar glycols
적정 처방 pH 안전 윈도우 (pH 0 ~ 14 스펙트럼)pH 2.0 – 12.0
0245.5791114

권장 구간 밖(pH < 2 또는 pH > 12)에서는 가수분해·점도 저하·이온 탈리 위험이 증가합니다.

공정 가열 한계 온도 (Max Process Temp)≤ 95°C
25°C45°C60°C75°C85°C100°C

최대 95°C 가열 공정에서 열적 안정성이 유지됩니다.

계면활성·유화 HLB 스펙트럼 (0 ~ 20) & 미셀/액정 배열 시뮬레이터
O/W 수중유형 미셀 에멀전 (수분 크림·로션)
HLB 11.5
W/O (3–6)Lamellar (8–10.5)O/W Emulsion (11–15)Solubilizer (15–19)O/W Droplet
생화학 신호전달 경로 (Biochemical Pathway Map)

세포·분자 타깃 작용 기전 플로우 다이어그램

1. 각질층·표피 작용→ 촉진·활성 (Activation)
각질층 세포간 지질 & 수분 결합 네트워크
→
경피수분손실(TEWL) 억제 및 피부결 개선
2. 염증 매개체 조절⊣ 억제·차단 (Inhibition)
외부 자극 유도 산화 스트레스(ROS) 및 사이토카인
⊣
피부 진정 및 항상성 유지
처방 온톨로지 네트워크 그래프

권장 시너지(🟢 실선) & 배합 금기·주의(🔴 점선) 인터랙티브 관계도

+ CETEARYL OLIVATE+ CYCLOPENTASILOXANE+ PHENYL TRIMETHICONE+ C15-19 ALKANE✕ 고점도 다이메티콘(>350 cSt)이…DIMETHICONE
노드 인터랙션 가이드

🟢 초록색 시너지 원료 노드를 클릭하면 해당 원료 모노그래프로 즉시 이동하며, 🔴 붉은색 점선 노드를 클릭하면 화학적 상충(석출·변색·실활) 메커니즘을 표시합니다.

대표 상용명 참고 (상표법 제90조 제1항 제2호 설명적 표기)
XIAMETER™ PMX-200 Fluid (6cSt ~ 1000cSt)Belsil® DM

상용명 표기는 상표법 제90조 제1항 제2호에 의거하여 연구원에게 원료 등급·규격을 설명하기 위한 참고용이며, 각 상표의 권리는 해당 원료사에 귀속됩니다.

학술·독성·제형 종합 요약 (Tier 1~3 탄력 요약)

Tier 1 Synthesis

이 원료에 매칭된 PubMed 동료심사 논문 초록과 공인 독성 보고서만으로 작성된 학술 요약입니다.

■ [1. 화학적 정체성 및 규격 (Chemical Identity & Standard Nomenclature)] - 표준명: 다이메티콘 | INCI: DIMETHICONE | CAS No.: 63148-62-9 | EC No.: N/A - 기원 및 분류: SYNTHETIC | 주요 기능: 피부컨디셔닝제, 피부보호제, 소포제, 에모리엔트 - 물리화학 스펙: 분자식 (C2H6OSi)n | 분자량 고분자/복합물(Polymer/Complex) | 친수/친유 밸런스 특화 | 이온성: non-ionic | PubChem CID 24759 - 7대 권역 공식 라벨 표기: KR [다이메티콘] · EU [DIMETHICONE] · US [DIMETHICONE] · CN [聚二甲基硅氧烷] · JP [ジメチコン] · JP의약부외품 [メチルポリシロキサン] ■ [2. 피부과학적 작용 기전 및 제형 내 역할 (Mechanism of Action & Function)] - 이 원료는 트라이메틸셀록시 단위로 끝이 막힌 완전 메틸화된 선형 실록세인 중합체 혼합물이다. 물리화학적 분류상 기원(synthetic)에 기반하여 피부 장벽 및 제형 매트릭스 내에서 고유한 기능(피부컨디셔닝제, 피부보호제, 소포제, 에모리엔트)을 수행하며, 계면 안정화·보습·피부 컨디셔닝 또는 유효성분 전달에 기여합니다. ■ [3. 글로벌 6대 권역 법정 규제 및 안전성 한도 (Layer 1 & Layer 2 Regulatory Matrix)] - 6개국 요약: KR: NONE | EU: NONE | US: NONE | CN: ALLOWED | JP: NONE | ASEAN: NONE (중국 IECIC(2025) 등재번호 3732 (聚二甲基硅氧烷)) - 6대 주요 권역(KR·EU·US·CN·JP·ASEAN) 별도 배합금지/특수제한 고시 없음 (GMP 일반 안전 기준 내 배합 허용). - 공인 안전성·역사적 사용 농도(Layer 2): CN_IECIC_2025 (cn_iecic_max, leave_on): 최대 85.0% / CN_IECIC_2025 (cn_iecic_max, rinse_off): 최대 30.0% ■ [4. 제형군별 통상 배합 가이드 (Layer 3-A Formulation Dosage Guide)] - [emulsion_cream] 권장 범위: 0.5 ~ 10.0% (중앙값 2.0%, 근거: Dow XIAMETER PMX-200 100cSt TDS & CIR Assessment) — 유화 백탁(Soaping) 즉시 제거, 실키한 발림성 및 통기성 보호막 형성 - [sun_color] 권장 범위: 1.0 ~ 20.0% (중앙값 5.0%, 근거: US FDA OTC Skin Protectant Monograph (1~30%) & CIR) — 선크림·프라이머 발수성 및 매끄러운 피니시 부여 - [anhydrous_balm] 권장 범위: 0.5 ~ 65.0% (중앙값 7.5%, 근거: Global Starter Formulation Library Statistical Distribution (n=8, GRANT 5 · ELEMENTIS 2 · EVONIK 1)) — 무수 밤·스틱·오일 처방 유상 골격 및 보습막 형성 ■ [5. 연구원 공정 설계 · 안정성 · 배합 금기 (Layer 3-B Process & Compatibility)] - 투입 공정(Phase): Oil / Silicone Phase - 적정 pH 구간: pH 2.0 ~ 12.0 | 공정 내열 온도: 최대 95°C | 전해질(염) 내성: HIGH - 배합 주의/금기: 고점도 다이메티콘(>350 cSt)이나 과량 배합 시 식물성 극성 오일과 상분리될 수 있으므로 유화제 HLB 밸런스 조정 필요 - 시너지 추천 원료: CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE | 참고 상용 원료명: XIAMETER™ PMX-200 Fluid (6cSt ~ 1000cSt), Belsil® DM ■ [6. 학술 논문 및 공인 문헌 근거 (Peer-Reviewed Literature & Compendia)] - PMID 41373051 (2025, J Dent Child (Chic)): Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish - PMID 39042700 (2024, PLoS Negl Trop Dis): A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay - PMID 42019729 (2026, J Am Acad Dermatol): Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to envi

근거 동료심사 학술 논문 (미국 NIH PubMed) (12)

Fluoride Release, Enamel Fluoride Uptake and Dentin Tubule Occlusion From A Novel Dimethicone-Based Fluoride Varnish [PMID: 41373051 · 2025]
Greenwood RM, Omoto N, Miller S, DeCamp R, Gross SM · J Dent Child (Chic) (2025)

Purpose: To measure the fluoride release and enamel fluoride uptake from a new dimethicone-based fluoride varnish (Profisil) and Duraphat fluoride varnish, and determine if the varnishes occlude dentin tubules. Methods: The fluoride release of both varnishes was measured from specimens with a constant surface area to volume ratio in a water bath. The fluoride uptake of demineralized enamel cores treated with both varnishes was studied over 24 hours using ion-specific electrodes to determine fluoride content and atomic absorption spectroscopy to determine calcium content. Scanning electron microscopy (SEM) was used to examine the occlusion of dentin tubules and the surface of enamel after treatment with varnish. Results: Duraphat varnish released 68&#xb1;7.1 ppm of fluoride per gram of varnish after 24 hours. Profisil varnish released 65&#xb1;6.3 ppm of fluoride per gram of varnish after 24 hours. Duraphat varnish specimens had a fluoride content of 2.5&#xb1;1.8 mg F/g enamel before application of the varnish, which increased to 285&#xb1;62 mg F/g enamel after 24 hours. Profisil varnish specimens had a fluoride content of 2.4&#xb1;2.1 mg F/genamel before application of the varnish, which increased to 272&#xb1;74 mg F/g enamel after 24 hours. SEM images depicted that both varnishes occluded open dentin tubules and left mineral deposits on the surface of the enamel. Conclusions: Both varnishes released significant amounts of fluoride and significantly increased the fluoride uptake of demineralized enamel. Moreover, the new varnish induced occlusion of the tubules and induced mineral growth on the surface of the enamel.

A pilot study of dimeticone oils versus sodium carbonate treatment for tungiasis: A randomized cohort trial in Homa Bay County, Kenya [PMID: 39042700 · 2024]
Suzuki K, Kamiya Y, Smith C, Kaneko S, Okomo G, Ongaya A, Amukoye E · PLoS Negl Trop Dis (2024)

Tungiasis is a cutaneous parasitosis caused by the female flea Tunga penetrans. Two-component dimeticone (NYDA) is the only treatment for tungiasis recommended by the World Health Organization; however, this topical drug is not available in Kenya. In Western Kenya, sodium carbonate is commonly used in the treatment of tungiasis. This study evaluated the 7-day cure rates for tungiasis by comparing sodium carbonate and NYDA treatments in Homa Bay County, Kenya. This was a randomized, observer-blinded, parallel-treatment cohort trial. Twenty-three eligible children with 126 flea infections were matched and randomized. All participants received both treatments, with one treatment on each foot. We recorded all health conditions/information, including inflammation scores and adverse events. Observations were performed on days 3, 5, and 7 using a digital microscope to confirm dead or live fleas based on the viability signs. Twenty-three children aged 3-13 years were analyzed. The proportion of dead fleas on day 7 was higher after NYDA treatment than after 5% sodium carbonate treatment (87% versus 64%, respectively, P = 0.01) NYDA. Median survival was 5 days for both treatments; NYDA had significantly higher trend of flea non-viability rate than 5% sodium carbonate (P&lt;0.01). There were no significant differences in the inflammation score or pain/itchiness between the two treatments. On the last day, 14 children indicated their preference for NYDA in future treatment of tungiasis, whereas nine children preferred the 5% sodium carbonate solution. NYDA was significantly more effective than 5% sodium carbonate for tungiasis treatment. Both treatments were safe but the children preferred NYDA more. Future studies with more participants and an extended observation period are warranted to confirm our findings. The findings suggest that NYDA should be made more available in tungiasis endemic area. UMIN-CTR; UMIN 000044320.

Plastic in dermatology: Impacts on human health, skin disease, and the contribution of personal care product use to environmental pollution [PMID: 42019729 · 2026]
Anderson A, Tan E, Dunlop S · J Am Acad Dermatol (2026)

There is increasing concern within the scientific community and the general population regarding the impacts of personal care product (PCP) use on human health and the environment. This article outlines evidence regarding the health and environmental impacts associated with PCP use. Specifically, it examines the impacts of intentionally added plastic particles or "microbeads"; microplastics and nanoplastics which are shed during plastic degradation from PCP packaging during use and once discarded in the environment; and chemicals of concern, including plastic-associated chemicals and nonplastic polymers not classified as plastics used in PCPs. Recommendations to reduce the impact of PCPs on human health and the environment will be discussed.

Tailoring the Stability of W/O/W Liquid Foundations: A Comparative Study of Polyglycerol-Based W/O Emulsifiers [PMID: 41835609 · 2026]
Zhu C, Zeng L, Xie Z, et al. · ACS Omega (2026)

Water-in-oil-in-water (W/O/W) multiple emulsions are thermodynamically unstable systems characterized by high interfacial free energy and complex thermodynamic driving force promoting internal droplet coalescence or Laplace pressure-driven water migration. In color cosmetics such as liquid foundations, this intrinsic instability is further exacerbated by the incorporation of inorganic pigments (e.g., titanium dioxide (TiO 2 ) and iron oxides), which perturb the delicate interfacial equilibrium and trigger premature phase separation. Utilizing polyglyceryl-10 stearate (PG10S) as a fixed oil-in-water (O/W) emulsifier, this study systematically investigated the stability of these challenging systems by assessing four polyglycerol-based water-in-oil (W/O) emulsifiers with distinct molecular architectures: polyglyceryl-3 polydimethylsiloxyethyl dimethicone (KF-6106), polyglyceryl-6 polyricinoleate (PR-15), polyglyceryl-3 polyricinoleate (PG3PR), and polyglyceryl-2 dipolyhydroxystearate (PGPH). Through a combination of confocal laser scanning microscopy (CLSM), rheometry, differential scanning calorimetry (DSC), surface/interfacial tension analysis, and accelerated stability testing, the structure-property relationships governing the integrity of the multiple-layered structure under both intrinsic and pigment-induced stresses were elucidated. The results demonstrate that the silicone-modified emulsifier (KF-6106) exhibited superior stabilizing efficacy, achieving a high thixotropic recovery of 91.16%. This performance is attributed to its ability to form a resilient, "self-healing" interfacial film with high segmental mobility, which effectively suppresses the spontaneous merging of internal droplets and maintains a robust barrier against the destabilizing effects of pigment particles. These findings establish a mechanistic framework for optimizing emulsifier selection and provide theoretical guidance for the rational design of stable, high-performance W/O/W multiple emulsions in complex, particle-filled systems.

Skin cleansers and leave-on product interventions for preventing incontinence-associated dermatitis in adults [PMID: 40643063 · 2025]
Graham T, Beeckman D, Kottner J, et al. · Cochrane Database Syst Rev (2025)

Incontinence-associated dermatitis (IAD) is a common skin problem in adults with urinary incontinence, faecal incontinence, or both. Prevention involves skin care interventions such as skin cleansing and the application of skin protectants/barriers (leave-on products). To assess the effects of skin care cleansers, leave-on products, and procedures for preventing incontinence-associated dermatitis in adults. On 29 April 2024, we searched the Cochrane Incontinence Specialised Register - which includes searches of CENTRAL, MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, ClinicalTrials.gov, and WHO ICTRP - and hand-searched journals and conference proceedings. We searched reference lists of included studies to identify additional studies. We selected randomised controlled trials (RCTs) and quasi-RCTs conducted in any healthcare setting and involving participants aged over 18 years without IAD at baseline. We included trials comparing the effectiveness of skin cleansing interventions and leave-on products or combinations of interventions/leave-on products. Three review authors independently screened the titles, abstracts, and full-text articles. Four review authors independently extracted data and assessed risk of bias. Data from studies not published in English were translated and extracted by volunteers from Cochrane Engage and the review authors' networks. Primary outcomes were: number of participants with IAD and adverse effects related to the intervention (pain, skin rash, itching, and other serious adverse effects). Secondary outcomes were: number of participants satisfied with skin care products or procedures, adherence to the protocol throughout the intervention, and quality of life (condition-specific or generic). We used GRADE to assess the certainty of the evidence. We included 15 trials with 1020 participants in a qualitative synthesis (41 participants from nursing homes; 65 from both care homes and hospital, and 914 from hospital settings). Participants had urinary incontinence, faecal incontinence, or both. Thirteen trials had small sample sizes and two trials had 180 and 174 participants. Six trials assessed outcomes in the short term (&#x2264; 7 days), four in the medium term (8 days-1 month), and one in the long term (&gt; 1 month-3 months). In the remaining studies, the timing of assessment was unclear. The overall risk of bias in the included studies was high. Substantial heterogeneity (in study populations, skin care products, skin care procedures, outcomes, and measurement tools) precluded meta-analysis. Three trials compared skin cleansing interventions, and five trials compared leave-on products or a combination of leave-on products. Seven trials compared a combination of skin cleansers and leave-on products. Number of participants with incontinence-associated dermatitis Three trials compared a skin cleanser with soap and water. One provided evidence that using a foam cleanser might be more effective than soap and water for preventing IAD (RR 0.35, 95% CI 0.14 to 0.85; 65 participants; very low-certainty evidence), while another found little or no difference in effectiveness between a disposable washcloth containing 3% dimethicone and soap and water (RR 0.14, 95% CI 0.01 to 2.28; 12 participants; very low-certainty evidence). The third trial reported lower erythema scores with a no-rinse skin cleanser compared with soap and water, but we were unable to analyse these data. In trials evaluating combinations of skin cleansers and leave-on products versus skin cleansing alone, one suggested the combined treatment may be more effective for preventing IAD (RR 0.03, 95% CI 0.00 to 0.53; 180 participants; very low certainty of evidence), and the other showed little to no difference between interventions (RR 0.71, 95% CI 0.14 to 3.68; 31 participants; very low-certainty evidence). Two studies showed little to no difference between a combination of leave-on products versus a single product (RR 0.85, 95% CI 0.

Cleansing Mechanisms and Efficacy on Artificial Skin [PMID: 40333845 · 2025]
Slavova T, Stanimirova R, Marinova K, et al. · Molecules (2025)

A systematic study on the mechanisms of cleansing artificial skin by solutions of widely used in personal care surfactants disodium laureth sulfosuccinate (DSLSS), sodium laureth sulfate (SLES), sodium dodecyl sulfate (SDS), dodecyl trimethyl ammonium bromide (DTAB), and coco glucoside (CG), is presented. The systematic characterization of soil removal from artificial skin revealed two primary cleansing mechanisms: emulsification and roll-up. Emulsification occurs in systems with very low interfacial tension, such as sebum in SLES solutions, while dimethicone soil was only removed by roll-up. The roll-up effectiveness depends on the surfactant's interfacial activity and its adsorption on the soiled surface. Thus, the strong adsorption of DTAB on the skin leads to dimethicone roll-up at a relatively high interfacial tension of 11 mN/m. The anionic and nonionic surfactants adsorbed less at the artificial skin surface, and the oil/water interfacial tension value lowering below 5 mN/m is necessary for the roll-up to occur. Nonionic CG removed dimethicone at a lower concentration than ionic surfactants. Combining CG with ionic surfactants improved cleaning at lower total concentrations. Surfactant mixtures are used to formulate simple cleansing formulations, whose performance is also investigated by the developed in vitro approach. The results obtained allow for a good rating of the formulations, which correlates well with the performance of the surfactant mixtures and their interfacial activity.

The Role of Moisturizer Containing Anti-inflammatory on Skin Hydration in Mild-Moderate Atopic Dermatitis Patients [PMID: 39741562 · 2024]
Prakoeswa CRS, Damayanti, Anggraeni S, et al. · Dermatol Res Pract (2024)

Atopic dermatitis (AD) is a chronic, inflammatory skin condition characterized by eczema lesions and dry, itchy skin. Recent guidelines for the management of AD emphasize the importance of using moisturizers in the management of AD. This study is a double-blind clinical trial to determine the effectiveness of moisturizers containing anti-inflammatory ingredients compared with moisturizers without anti-inflammatory ingredients for skin hydration in mild to moderate adult AD patients for 14&#x2009;days at the Dermatology and Venereology Outpatient Clinic at Dr. Soetomo General Academic Hospital. There was a significant difference ( p &lt; 0.05) at the baseline and day 14 skin hydration values in the experiment group with anti-inflammatory ingredients (35.97&#x2009;&#xb1;&#x2009;6.04-66.06&#x2009;&#xb1;&#x2009;15.84) and the control group without anti-inflammatory ingredients (40.74&#x2009;&#xb1;&#x2009;10.94-56.12&#x2009;&#xb1;&#x2009;8.34). After comparison, there was a significant difference ( p &lt; 0.05) in the skin hydration value between the experiment group and the control group on the 14th day. There was also a significant difference in the improvement of skin hydration outcomes between both groups ( p &lt; 0.05). The severity of the disease using Scoring Atopic Dermatitis (SCORAD) showed a significant difference ( p &lt; 0.05) between the experiment group and the control group after 2&#x2009;weeks of intervention. The addition of anti-inflammatory ingredients in the moisturizer, namely, shea butter, bacterial lysate, allantoin, bisabolol, Phragmites kharka extract, Poria cocos , and Mirabilis jalapa in a moisturizer containing occlusive (dimethicone), humectants (glycerin, saccharide, butylene glycol, and hyaluronic acid), and emollient (shea butter and squalane) was shown to be significantly better in improving skin hydration in patients with mild to moderate AD.

Structural Similarity-Induced Inter-Component Interaction in Silicone Polymer-Based Composite Sunscreen Film for Enhanced UV Protection [PMID: 39684059 · 2024]
Chen Y, Xu H, Liu Y, et al. · Polymers (Basel) (2024)

Film-forming agents are key ingredients in achieving long-lasting and effective sun protection by sunscreens. However, studies on the synergistic effects of film-forming agents with different properties as well as the interaction between film-forming agents and powders are scarce, restricting the development of sunscreens with strong ultraviolet (UV)-shielding effects. Herein, we innovatively adopt polysiloxane-15 as the soft film, trimethylsiloxysilicate as the hard film, and vinyl dimethicone/methicone silsesquioxane crosspolymer as the functional powder to construct a co-assembled sunscreen film, and we investigate the property-enhancing effects of the sunscreen film as well as the interaction between the silicone polymer-based film-forming agents and functional powder therein. The results show that structural similarity is essential to generating film-forming agent-powder interactions, which primarily enhance the Si-O bond binding energy, thereby enhancing the lasting protection effect of sunscreens. In addition, the inter-component interaction of the co-assembled sunscreen film inhibits the agglomeration of sunscreen paste to facilitate the formation of a homogeneous film, endowing the sunscreen with excellent UV protection abilities, with the sun protection factor (SPF) and protection factor of UVA (PFA) values increased by 61.58 and 43.84%, respectively. This work offers novel insights into the optimization of film-forming agent properties and the development of durable and efficient sunscreens.

Characteristics of Diaper Dermatitis in Patients Aged 0-24 Months After Congenital Heart Disease and the Effects of a Diaper Dermatitis Care Bundle: A Comparison of 2 Groups [PMID: 39588819 · 2024]
Chin PJ, Liao LN, Huang LC · J Wound Ostomy Continence Nurs (2024)

The purpose of this study was to examine characteristics of diaper dermatitis (DD) in critically ill patients aged 0 to 24&#xa0;months following surgery for congenital heart disease (CHD), the effects of a diaper dermatitis care bundle (DDCB), and factors associated with the development of DD in this population. Nonrandomized comparison cohort study with a historical comparison group. Convenience sampling was used to identify children aged 0 to 24&#xa0;months undergoing CHD and cared for in a pediatric intensive care unit in central Taiwan (Taichung). The sample comprised 54 participants; 24 were in the historical comparison group and 30 received the DDCB. The rate of DD from the historical comparison group was compared to that in an intervention group managed with a bundle of interventions used to prevent and manage DD, which includes the routine use of a topical skin protectant. The participants in the historical comparison group received usual care to prevent and manage DD including routine cleansing with a moistened, disposable cloth every 3&#xa0;hours and following defecation or urination. The DDCB comprised diaper changes at least every 3&#xa0;hours and as needed after soiling, along with the routine application of a dimethicone and sodium hyaluronate-based skin protectant before diaper changes. Both groups were evaluated for use of an antifungal cream when candidiasis was present. Participants managed with the DDCB have a significantly lower rate of DD than the historical comparison group who received routine care (41.65% vs 6.67%, P =&#xa0;.002). Univariate logistic regression showed an odds ratio of 0.10 (95% confidence interval of 0.019-0.520, P =&#xa0;.006), suggesting that the DDCB acted as a protective factor against the development of DD. Multivariate analysis of the historical comparison group indicated that non-cyanotic heart disease was associated with a lower likelihood of postoperative DD compared to those with cyanotic heart disease (odds ratio&#xa0;=&#xa0;0.01, 95% confidence interval of 0.000-0.946, P =&#xa0;.047). Managing critically ill patients with a DDCB recovering from cardiac surgery significantly decreased the incidence of DD. We recommend routine use of this type of care bundle for preventing DD in this vulnerable population in all children with CHD, with particular attention being paid to this with cyanotic CHD.

A New Prescription Emollient Device (PED) For Psoriasis of Sensitive Areas and Folds: A Randomized Prospective Open Trial [PMID: 39564575 · 2024]
Dall'Oglio F, Verzì AE, Guglielmi G, et al. · Psoriasis (Auckl) (2024)

Psoriasis affecting sensitive areas and folds represents a therapeutic challenging as the skin in these areas may be more prone to local pharmacological side effects. The aim of this prospective, randomized, open-label study was to evaluate the efficacy and tolerability of a new prescription emollient device (PED) as a cream containing primarily furfuryl palmitate (antioxidant, anti-inflammatory, soothing), tocopherol (antioxidant), and dimethicone (occlusive) for the treatment of psoriasis localized to difficult-to-treat areas. Thirty patients (14M/16F) with mild-to-moderate psoriasis of sensitive areas such as face, vulva, scrotum, pubic area, neck (15 cases), and of folds including axillary fossa, intergluteal cleft, submammary/inguinal folds, and umbilicus (15 cases) were consecutively enrolled and instructed to apply the cream twice daily for 8&#xa0;weeks. Efficacy was assessed at baseline, at 4 and 8&#xa0;weeks by measuring the degree of erythema, scaling, infiltration and pruritus using clinical, instrumental and subject-completed Visual Analog Scale (VAS) assessments. At the end of the study, the Investigator Global Assessment (IGA) of efficacy was performed. Statistically significant reductions in erythema, scaling, infiltration, and itching scores were observed at 8&#xa0;weeks compared to baseline. In addition, IGA efficacy score was clear in 7 cases and almost clear in 4 cases for psoriasis of sensitive areas and clear in 5 cases and almost clear in 4 cases for psoriasis of folds. No relevant side effects were observed in any of the groups. Our results suggest that the tested PED containing antioxidant, anti-inflammatory, soothing and occlusive agents may represent a valid therapeutic option for mild-to-moderate psoriasis of sensitive areas and folds in monotherapy or in combination with pharmacological agents if necessary.

Impact of Different Packaging Configurations on A Topical Cream Product [PMID: 39349693 · 2024]
Mohammed YH, Namjoshi SN, Telaprolu KC, et al. · Pharm Res (2024)

The objective of this study was to investigate whether different dispensing processes can alter the physicochemical and structural (Q3) attributes of a topical cream product, and potentially alter its performance. Acyclovir cream, 5% (Zovirax&#xae;) is sold in the UK and other countries in a tube and a pump packaging configurations. The structural attributes of the cream dispensed from each packaging configuration were analyzed by optical microscopy, confocal Raman microscopy and cryo-scanning electron microscopy. Rheological behavior of the products was also evaluated. Product performance (rate and extent of skin delivery) was assessed by in vitro permeation tests (IVPT) using heat-separated human epidermis mounted in static vertical (Franz-type) diffusion cells. Differences in Q3 attributes and IVPT profiles were observed with creams dispensed from the two packaging configurations, even though the product inside each packaging appeared to be the same in Q3 attributes. Visible globules were recognized in the sample dispensed from the pump, identified as dimethicone globules by confocal Raman microscopy. Differences in rheological behaviour could be attributed to these globules as products not dispensed through the pump, demonstrated a similar rheological behaviour. Further, IVPT confirmed a reduced rate and extent to delivery across human epidermis from the product dispensed through a pump. Different methods of dispensing topical semisolid products can result in metamorphosis and Q3 changes that may have the potential to alter the bioavailability of an active ingredient. These findings have potential implications for product developers and regulators, related to the manufacturing and comparative testing of reference standard and prospective generic products dispensed from different packaging configurations.

Safety Assessment of Vinylpyrrolidone Polymers as Used in Cosmetics [PMID: 39045851 · 2024]
Johnson W Jr, Bergfeld WF, Belsito DV, et al. · Int J Toxicol (2024)

The Expert Panel for Cosmetic Ingredient Safety (Panel) reviewed the safety of 30 vinylpyrrolidone polymers as used in cosmetic products; most of these ingredients have the reported cosmetic function of film former in common. The Panel reviewed data relevant to the safety of these ingredients, and determined that 27 vinylpyrrolidone polymers are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The Panel also concluded that the available data are insufficient to make a determination that 3 vinylpyrrolidone polymers (all urethanes) are safe under the intended conditions of use in cosmetic formulations.

자주 묻는 질문 (AEO 스니펫 최적화 FAQ)

Q1. 다이메티콘 (DIMETHICONE)의 국가별 공식 전성분 표기명은 어떻게 다른가요?
한국 식약처 표준명은 '다이메티콘', 미국 PCPC 및 유럽 CosIng INCI 표기는 'DIMETHICONE', 중국 NMPA IECIC 표준명은 '聚二甲基硅氧烷', 일본 화장품 표시명칭은 'ジメチコン'입니다.
Q2. 다이메티콘의 글로벌 6대 권역 법정 배합 한도(Layer 1)는 무엇인가요?
한국(KR: none), 유럽(EU: none), 미국(US: none), 중국(CN: allowed), 일본(JP: none), 아세안(ASEAN: none) 고시 기준을 준수하여 처방해야 합니다.
Q3. 제형 설계 시 다이메티콘의 통상 배합 농도(Layer 3)와 적정 pH는 얼마인가요?
대표 제형군(emulsion_cream) 기준 통상 0.5~10%(권장 중앙값 2%) 범위로 투입하며, 적정 pH는 2~12입니다.
Q4. 다이메티콘 배합 시 주의해야 할 상용성 금기(Incompatibilities)와 시너지 성분은 무엇인가요?
주요 권장 시너지 조합은 CETEARYL OLIVATE, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, C15-19 ALKANE이며, 배합 주의사항은 고점도 다이메티콘(>350 cSt)이나 과량 배합 시 식물성 극성 오일과 상분리될 수 있으므로 유화제 HLB 밸런스 조정 필요입니다.