# HYDROLYZED SPONGE (hydrolyzed-sponge) — Global Cosmetic Regulatory & Formulation Monograph - **Canonical URL**: https://www.inciname.com/en/ingredients/hydrolyzed-sponge - **Standard INCI**: `HYDROLYZED SPONGE` - **KR MFDS Standard Name**: `하이드롤라이즈드해면` - **CAS No.**: `N/A` - **EC / EINECS No.**: `N/A` - **Origin**: `synthetic` - **Functions**: 피부컨디셔닝제 - **Molecular Formula / MW**: `SiO2·nH2O (Biogenic Amorphous Silica + Sponge Peptide Matrix)` (— g/mol) ## 1. 7-Track Official Regulatory Label Names | Track | Official Label Nomenclature | | :--- | :--- | | KR (MFDS Standard) | 하이드롤라이즈드해면 | | KR (Former Names) | — | | EU (CosIng 1223/2009) | HYDROLYZED SPONGE | | US (PCPC / MoCRA INCI) | HYDROLYZED SPONGE | | US (FDA OTC Monograph) | — | | CN (NMPA IECIC) | 水解海绵 | | JP (JCIA / MHLW QD) | 加水分解カイメン (QD: 加水分解カイメン) | ## 2. Layer 1 — Global 6-Region Statutory Summary - **KR (MFDS)**: `none` - **EU (1223/2009)**: `none` - **US (FDA/MoCRA)**: `none` - **CN (NMPA IECIC)**: `allowed` (Entry: `6306`) - **JP (MHLW)**: `none` - **ASEAN (ACD)**: `none` ## 3. Layer 2 — Toxicological & Historical Safe Use Concentrations - **cn_iecic_max** (leave_on): ≤ 2% — NMPA IECIC (2025) Entry 06145 (2025) - **cn_iecic_max** (rinse_off): ≤ 1% — NMPA IECIC (2025) Entry 06145 (2025) ## 4. Layer 3 — Formulation Quartiles & Compatibility - **Optimal pH Window**: 4.5 – 7.5 - **Max Process Temp**: ≤ 70°C - **Synergy Pairings**: SODIUM DNA, PANTHENOL, MADECASSOSIDE, COPPER TRIPEPTIDE-1, POLYACRYLATE CROSSPOLYMER-6, ECTOIN - **Incompatibilities**: High specific gravity (~2.0) causes sedimentation in low-yield-stress fluids; requires Polyacrylate Crosspolymer-6 or Carbomer + Xanthan Gum yield-stress gel network; Avoid prolonged high-shear homogenization (>3,500 rpm) after addition to prevent mechanical fracture of silica micro-needles ## 5. Academic Monograph ■ [1. Chemical Identity & International Labeling Nomenclature] - INCI Name: HYDROLYZED SPONGE | CAS No.: N/A | EC No.: N/A - Origin: SYNTHETIC | Functions: Skin Conditioning - Physicochemical Profile: Formula SiO2·nH2O (Biogenic Amorphous Silica + Sponge Peptide Matrix) | MW /(Polymer/Complex) | / | Ionic Nature: non-ionic | CosIng/MFDS - Official Regional Label Names: US [HYDROLYZED SPONGE] · EU [HYDROLYZED SPONGE] · CN [水解海绵] · JP [加水分解カイメン] · JP Quasi-Drug [加水分解カイメン] ■ [2. Dermatological Mechanism of Action & Functional Role] - High-purity biogenic amorphous silica micro-spicules (150~250 µm length, 10~15 µm diameter) isolated from freshwater sponges. Mechanically penetrates the stratum corneum to create transient physical micro-channels, dramatically enhancing the transdermal delivery of hydrophilic macromolecules (PDRN, exosomes, peptides, growth factors) while stimulating basal keratinocyte proliferation and dermal collagen remodeling. ■ [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. 6306 (水解海绵)) - 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 ~ 1.0% (Median 0.3%, Ref: UNIZ LAB Bio-Spicule Technical Monograph & PubMed PMIDs (33900650, 35383978)) — Micro-needle silica spicule transdermal delivery enhancer (DDS) - [emulsion_cream] Typical range: 0.05 ~ 1.0% (Median 0.25%, Ref: UNIZ LAB Bio-Spicule Technical Monograph & MFDS Standard) — Micro-channel skin renewal & barrier remodeling cream active ■ [5. Formulation Engineering, Stability & Incompatibility Matrix (Layer 3-B)] - Addition Phase: Final Cool-down Phase (< 45°C; Low-shear paddle mixing ONLY — avoid prolonged high-shear rotor-stator homogenization to prevent spicule needle fracture) - Optimal pH Range: pH 4.5 ~ 7.5 | Max Process Temp: Max 70°C | Electrolyte Tolerance: HIGH - Incompatibility / Caution: High specific gravity (~2.0) causes sedimentation in low-yield-stress fluids; requires Polyacrylate Crosspolymer-6 or Carbomer + Xanthan Gum yield-stress gel network - Incompatibility / Caution: Avoid prolonged high-shear homogenization (>3,500 rpm) after addition to prevent mechanical fracture of silica micro-needles - Synergy Pairings: SODIUM DNA, PANTHENOL, MADECASSOSIDE, COPPER TRIPEPTIDE-1, POLYACRYLATE CROSSPOLYMER-6, ECTOIN | Reference Trade Names: UNIZ LAB Bio-Spicule™ 99+, Spongilla Micro-Spicule ■ [6. Peer-Reviewed Literature & Official Compendia Evidence] - PMID 35034416 (2022, Journal of cosmetic dermatology): A novel dermal delivery system using natural spicules for cosmetics and therapeutics. - PMID 23513460 (2012, Journal of the Medical Association of Thailand = Chotmaihet thangphaet): The study on effects and safety of Spongilla lacustris in 3% hydrogen peroxide solution on rat skin. - PMID 37295506 (2023, Journal of the American Academy of Dermatology): DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b ## 6. Linked PubMed Literature - [PMID: 35034416] A novel dermal delivery system using natural spicules for cosmetics and therapeutics. — *Journal of cosmetic dermatology* (2022) - [PMID: 23513460] The study on effects and safety of Spongilla lacustris in 3% hydrogen peroxide solution on rat skin. — *Journal of the Medical Association of Thailand = Chotmaihet thangphaet* (2012) - [PMID: 37295506] DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial. — *Journal of the American Academy of Dermatology* (2023) - [PMID: 14787672] [Dermatitis, resembling scarlet fever, caused by Spongilla fluviatilis]. — *Sovetskaia meditsina* (1950) - [PMID: 41155317] Nano-Encapsulated Spicule System Enhances Delivery of Wharton's Jelly MSC Secretome and Promotes Skin Rejuvenation: Preclinical and Clinical Evaluation. — *International journal of molecular sciences* (2025) - [PMID: 41597907] A Multifunctional Peptide Linker Stably Anchors to Silica Spicules and Enables MMP-Responsive Release of Diverse Bioactive Cargos. — *Micromachines* (2026) - [PMID: 40103747] Enhanced Dermal Delivery of Nanoparticulate Formulation of Cutibacterium acnes Using Sponge Spicules for Atopic Dermatitis Treatment. — *International journal of nanomedicine* (2025) - [PMID: 39613270] Design, fabrication, and evaluation of antimicrobial sponge microneedles for the transdermal delivery of insulin. — *European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V* (2025) - [PMID: 38616270] Mesoporous silica coated spicules for photodynamic therapy of metastatic melanoma. — *Journal of nanobiotechnology* (2024) - [PMID: 37331627] Development and Assessment of Acyclovir Gel Plaster Containing Sponge Spicules. — *Journal of pharmaceutical sciences* (2023) - [PMID: 34254062] Transdermal delivery of heparin using low-frequency sonophoresis in combination with sponge spicules for venous thrombosis treatment. — *Biomaterials science* (2021) - [PMID: 28763230] Skin Delivery of Hydrophilic Biomacromolecules Using Marine Sponge Spicules. — *Molecular pharmaceutics* (2017) - [PMID: 39204189] Novel Synergistic Approach for Bioactive Macromolecules: Evaluating the Efficacy of Goat Placenta Extract in PEGylated Liposomes and Microspicules for Chemotherapy-Induced Hair Loss. — *Pharmaceuticals (Basel, Switzerland)* (2024) - [PMID: 38044095] Potential Lipolytic Effect of Panduratin A Loaded Microspicule Serum as a Transdermal Delivery Approach for Subcutaneous Fat Reduction. — *Biological & pharmaceutical bulletin* (2023) - [PMID: 33545292] Hair growth promoting effect of bioactive extract from deer antler velvet-loaded niosomes and microspicules serum. — *International journal of pharmaceutics* (2021) - [PMID: 28392646] The Effect of Micro-Spicule Containing Epidermal Growth Factor on Periocular Wrinkles. — *Annals of dermatology* (2017) - [PMID: ] Skin Delivery of Hydrophilic Biomacromolecules Using Marine Sponge Spicules — *Molecular Pharmaceutics* (2017) - [PMID: ] Spicule + EGF Microchannel Delivery — Korean Clinical Study — *Annals of Dermatology* (2017) - [PMID: ] Hyaluronic Acid-Liposome Sponge Spicule Hybrid Delivery — *Biomaterials Science* (2019) - [PMID: ] Nano-Encapsulated Spicule System Enhances Delivery of Wharton’s Jelly MSC Secretome and Promotes Skin Rejuvenation: Preclinical and Clinical Evaluation — *International Journal of Molecular Sciences* (2025) - [PMID: ] Niacinamide Spicule Microchannel Delivery — *Pharmaceutics* (2019) - [PMID: ] Sphistin Antimicrobial Peptide + Spicule Delivery — *Drug Delivery and Translational Research* (2025) - [PMID: 12191682] Microparticles derived from marine sponge collagen (SCMPs): preparation, characterization and suitability for dermal delivery of all-trans retinol. — *European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V* (2002) - [PMID: 19365781] Preparation and characterization of marine sponge collagen nanoparticles and employment for the transdermal delivery of 17beta-estradiol-hemihydrate. — *Drug development and industrial pharmacy* (2009) - [PMID: 28403652] A contribution to pharmaceutical biology of freshwater sponges. — *Natural product research* (2018) - [PMID: ] Skin delivery of hyaluronic acid by the combined use of sponge spicules and flexible liposomes — *Biomaterials science* (2019) - [PMID: 31923929] Bio-based polymer nanofiber with siliceous sponge spicules prepared by electrospinning: Preparation, characterisation, and functionalisation. — *Materials science & engineering. C, Materials for biological applications* (2020) - [PMID: ] Topical Application of Exosomes Derived from Human Umbilical Cord Mesenchymal Stem Cells in Combination with Sponge Spicules for Treatment of Photoaging — *International journal of nanomedicine* (2020) - [PMID: 32544582] Callophycin A loaded chitosan and spicules based nanocomposites as an alternative strategy to overcome vaginal candidiasis. — *International journal of biological macromolecules* (2020) - [PMID: ] A novel dermal delivery system using natural spicules for cosmetics and therapeutics. — *J Cosmet Dermatol* (2022) - [PMID: ] DMT310, a novel once-weekly topical treatment for patients with moderate-to-severe acne vulgaris: Results of a phase 2b randomized, double-blind, placebo-controlled trial — *Journal of the American Academy of Dermatology* (2023) - [PMID: 39055902] Biomimetic Marine-Sponge-Derived Spicule-Microparticle-Mediated Biomineralization and YAP/TAZ Pathway for Bone Regeneration In Vivo. — *Biomaterials research* (2024) - [PMID: ] The topical application of Sphistin12-38 in combination with sponge spicules for the acne treatment — *Drug delivery and translational research* (2025) - [PMID: ] Coated sponge spicules for remodeling skin immune homeostasis in psoriasis treatment by releasing self-assembled phospholipid complex nanoparticles — *Colloids and surfaces. B, Biointerfaces* (2025) - [PMID: ] Percutaneous extraction using sponge spicules for disease diagnosis and therapeutic drug monitoring — *Scientific reports* (2025) - [PMID: ] Topical delivery of Lidocaine using spicules for local anesthesia — *Drug delivery and translational research* (2025) - [PMID: ] Design, fabrication, and evaluation of antimicrobial sponge-hydrogel bilayer microneedles: An integrated system for transdermal insulin delivery and glucose sensing — *Biomaterials advances* (2026) - [PMID: 42354780] Redox-Responsive GHK-Conjugated Sponge Spicules for Sustained Dermal Delivery and Enhanced Collagen Synthesis. — *Micromachines* (2026) - [PMID: ] Development of Sponge Microspicule Cream as a Transdermal Delivery System for Protein and Growth Factors from Deer Antler Velvet Extract — *Biol Pharm Bull* (2019) - [PMID: ] Enhanced Skin Delivery of Therapeutic Peptides Using Spicule-Based Topical Delivery Systems — *Pharmaceutics* (2021) - [PMID: ] Comparison of Different Methods for Spongin-like Collagen Extraction from Marine Sponges (Chondrilla caribensis and Aplysina fulva): Physicochemical Properties and In Vitro Biological Analysis — *Membranes* (2021) - [PMID: ] A New Spongilipid from the Freshwater Sponge Spongilla lacustris — *Bulletin of the Korean Chemical Society* (2009) - [PMID: ] Study of Physicochemical and Technological Properties of Spongilla Powder — *National University of Pharmacy (Ukraine)* (2018) - [PMID: ] Biological and Medicinal Importance of Sponge — *IntechOpen (Book Chapter)* (2016) - [PMID: ] Skin delivery of siRNA using sponge spicules in combination with cationic flexible liposomes — *Molecular Therapy: Nucleic Acids* (2020) - [PMID: ] Microneedle Therapy: A Medik8 Briefing for the Scientific Community — *Medik8 Skin Research* (2009) - [PMID: ] Transdermal Delivery Systems Market Analysis — *Marketsandmarkets 시장보고서* (2019) - [PMID: ] Establishment of Evaluation Methods for High-Tech Pharmaceuticals — *고려대학교 세종산학협력단 / 식약처* (2018) - [PMID: ] Percutaneous Collagen Induction Therapy: An Alternative Treatment for Scars, Wrinkles, and Skin Laxity — *Plastic and Reconstructive Surgery* (2008) - [PMID: ] Microneedling in All Skin Types: A Review — *Journal of Drugs in Dermatology* (2017) - [PMID: ] Effect of Curcumin and Spicule on the Improvement of Keratosis Pilaris — *건국대학교 산업대학원 (석사학위논문)* (2013) - [PMID: ] Comparative Study on Changes in Skin Condition according to Peeling Care Techniques — *Asian Journal of Beauty and Cosmetology* (2018) - [PMID: ] The Study on Effects and Safety of Spongilla lacustris in 3% Hydrogen Peroxide Solution on Rat Skin — *Journal of the Medical Association of Thailand* (2012) - [PMID: ] Use of Spongilla lacustris Powder for Treatment of Sports Injuries — *National University of Pharmacy (Ukraine)* (2015) - [PMID: ] Comparison of Exfoliation Effects of Deep Cleansers by Skin Type — *대한피부미용학회지* (2009) - [PMID: ] Study on the Local Wrinkle Cure Using Acupuncture Needle — *동의생리병리학회지* (2009) - [PMID: ] A Solid State NMR Investigation of Recent Marine Siliceous Sponge Spicules — *Minerals (MDPI)* (2016) - [PMID: ] Structural Characterization of Siliceous Spicules from Marine Sponges — *Biophysical Journal* (2004) - [PMID: ] Analysis of silicatein gene expression and spicule formation in the demosponge Amphimedon queenslandica — *University of Queensland (MPhil thesis)* (2014) - [PMID: ] Orthosilicic acid stimulates collagen type 1 synthesis and osteoblastic differentiation in human osteoblast-like cells in vitro — *Bone* (2003) - [PMID: ] Effect of oral intake of choline-stabilized orthosilicic acid on skin, nails and hair in women with photodamaged skin — *Archives of Dermatological Research* (2005) - [PMID: ] Epidermal "turnover time" — a re-examination — *British Journal of Dermatology* (1972) - [PMID: ] Induction of apoptosis of prostate cancer cells by the extract of the freshwater sponge — *Molekulyarnaya Meditsina (Molecular medicine)* (2022) - [PMID: ] Medicinal raw materials of animal origin (review) — *Вестник фармации* (2012) - [PMID: ] Badyaga harvesting: history and present state — *Рыбное хозяйство* (2014) - [PMID: ] Carbohydrate specificity of lectins — *학회 논문집(конференция)* (2014) - [PMID: ] Isolation and purification of lectins from Spongilla lacustris — *학회 논문집(конференция)* (2014) - [PMID: ] Badyaga sponge: fishery and biological value — *학회 논문집(конференция)* (2021) - [PMID: 41393269] Hydrolyzed Marine Collagen: Emerging Evidence of Benefits via the Oral Route - Review and Insights for Medical Aesthetics Practitioners. — *Clin Cosmet Investig Dermatol* (2025) - [PMID: 32330363] Wound healing action of nitric oxide-releasing self-expandable collagen sponge. — *J Tissue Eng Regen Med* (2020) - [PMID: 35082971] Adipose-Derived Stem Cell-Incubated HA-Rich Sponge Matrix Implant Modulates Oxidative Stress to Enhance VEGF and TGF-β Secretions for Extracellular Matrix Reconstruction In Vivo. — *Oxid Med Cell Longev* (2022) - [PMID: 37422339] Risk of bleeding in anticoagulated patients undergoing dental extraction treated with topical tranexamic acid compared to collagen-gelatin sponge: Randomized clinical trial. — *J Craniomaxillofac Surg* (2023) - [PMID: 35915285] Mechanically Enhanced Salmo salar Gelatin by Enzymatic Cross-linking: Premise of a Bioinspired Material for Food Packaging, Cosmetics, and Biomedical Applications. — *Mar Biotechnol (NY)* (2022) - [PMID: ] Nano-Encapsulated Spicule System Enhances Delivery of Wharton's Jelly MSC Secretome and Promotes Skin Rejuvenation: Preclinical and Clinical Evaluation — *PMC12564063* (2025)