Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- INCI Name
- Ingredient Origin
- Cosmetic Ingredients Functions
- CAS No.
- 1314-13-2
- EC No.
- 215-222-5
- Technologies
Features & Benefits
- Benefit Claims
- Labeling Claims
- Product Highlights
Non-penetrating and safe
Zano® filters are very mild on the skin and have been tested to cause no irritation and sensitization and are non photo-allergenic. Zano® combines all other skin benefits of zinc oxide, such as anti-inflammatory, anti-microbial and and skin healing properties.
Natural and photostable
As a mineral product abundantly present on the globe, zinc oxide is considered as a natural UV filter. All uncoated Zano® are Cosmos and Ecocert certified. Zano® products are photostable without the use of stabilizers and do not lose their performance upon sunlight radiation.
Applications & Uses
- Markets
- Applications
- Sun Care Applications
- Use Level
- max. 25% (UV filter)
Properties
- Appearance
- White powder
- Odor
- Odourless
- Typical Properties
- Heavy Metals
| Value | Units | Test Method / Conditions | |
| Critical Wavelength | 371.0 | nm | — |
| SPF | approx. 1.5 | Units | — |
| UVA-PF | approx. 0.6 | Units | — |
| Zinc Oxide (Nominal Content) | 100 | % wt | — |
| Natural Index (Zano® 20) | 0 | — | ISO 16128-1:2016 and ISO 16128-2:2017 |
| Natural Origin Index (Zano® 20) | 1 | — | ISO 16128-1:2016 and ISO 16128-2:2017 |
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 2 | ppm | — |
| Cadmium Content | max. 10 | ppm | — |
| Lead Oxide Content | max. 20 | ppm | — |
Regulatory & Compliance
- Certifications & Compliance
- COSMOS
Certified
- Statements
Allergens
- Regulation (EC) n°1223/2009 as amended: Zano® 20 is free of allergens.
- Regulation (EC) 1169/2011 – Annex II: Based on our best knowledge, the listed food allergens are not likely to be present in Zano® 20.
Gluten
This raw material is, based on best of our knowledge, free of gluten.
Substances Prohibited
This raw material does not contain any of the substances listed in Annex II ('List of substances prohibited in cosmetic products') of the European Commission's Cosmetic Ingredient Database (CosIng).
GMO
Zano® 20 does not contain and/or is manufactured from Genetic Manipulated Organisms (GMO).
Microbial stability
Zano® 20 being a zinc oxide (CAS: 1314-13-2) powder, is free of micro-organisms. Zinc oxide is known to present bacteriostatic properties.
BSE/TSE
Zano® 20 is free of animal derived ingredients. As a result, Zano® 20 is free of Transmissible Spongiform Encephalopathy (TSE), including Bovine Spongiform Encephalopathy (BSE).
Animal testing
Zano® 20 has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of EverCare.
VOC
Zano® 20 is free of Volatile Organic Compounds.
Residual Solvent
Zano® 20 is produced with a process free of solvent. Zano® 20 is consequently free of residual solvents.
SVHC
Zano® 20 does not contain any Substances of Very High Concern (SVHC) as listed on the ECHA Website in the “Candidate List of Substances of Very High Concern for authorisation”, last up-dated 8th of July 2021, in a concentration above 0.1%.
CMR
Zano® 20 is not manufactured using substances classified as CMR (Carcinogenic, Mutagenic, Toxic for reproduction). Moreover , under normal and foreseeable circumstances Zano® 20 would not be expected to contain any substances classified as CMR above generally acknowledged regulatory standards or technical limit guidelines.
Endocrine distruptor
Zano® 20 is not a Endocrine distruptor (ED). Zano® 20 is free of ED.
CITES
Zano® 20 does not contain any plants which are protected by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).
Halal
Zano® 20:
- Does not contain nor come into contact with animal derived materials during manufacture and storage.
- Does not contain nor come into contact with alcohol and/or alcohol derived materials during manufacture and storage.
- Zano® Products are manufactured and tested in compliance with GMP Part II / ICH Q7 requirements
- Therefore, infringement of Islamic food laws is, based on our best knowledge and quality standards, excluded. An official certificate to this effect is not available.
Kosher
This raw material is not derived from, nor does it contain pork and/or pork derivatives. Therefore, infringement of Jewish food laws is, based on our best knowledge, excluded. An official certificate to this effect is not available.
Vegan
- This raw material is free of animal* origin and no animal* product, by-product or derivative are used within manufacturing process (e.g. additives, carrier substances, auxiliary materials like e.g. nutrient media used for fermented-based ingredients).
- * The term animal refers to the entire animal kingdom, that is all vertebrates and all multicellular invertebrates.
- Zano® 20 is consequently compliant with vegan standards.
Conflict Minerals
Zano® 20 is used free of Conflict Minerals as defined by the Dodd-Frank Act (e.g. gold, tin, tantalum, and tungsten emanating from the Democratic Republic of Congo (DRC) and adjoining countries (DRC countries)).
Proposition 65
- No ingredients going in to the composition of the Zano® 20 are listed under the California Proposition 65.
- Moreover Zano® 20 typically contains trace impurities of cadmium < 10 ppm, lead oxide < 20 ppm (expressed as lead) and arsenic < 2 ppm which are known to the state of California to cause cancer or reproductive toxicity as listed under Proposition 65 State Drinking Water and Toxic Enforcement Act.
Palm Origin
This material does not contain palm oil derived ingredients.
Heavy Metals
- Monitoring of heavy metals is carried out on a regular basis.
- If present, trace heavy metal levels in Zano® 20 will be well within the limits of the American (USP) and European (EP) pharmacopeia.
Microplastics
This material is not and does not contain microplastics.
Impurities
The presence of any impurities is non-intended and technically unavoidable in good manufacturing practice.
- Registration
REACH
- Zano® 20 (as 100 % zinc oxide) is registered and compliant with current Reach regulations.
- As European manufacturer of the zinc oxide (EINEC number 215-222-5), the registration reference for EZUF NL B.V is 01-2119463881-32-0212.
FDA
- EZUF NL B.V is registered as drug establishment with F.E.I number 3016994900.
- Zano® 20 is registered with the US FDA with the NDC code 15613-600.
- Zano® 20 is compliant for OTC products on US market.
- Cosmetic Regulations
Zano® 20 as zinc oxide (CAS: 1314-13-2), is
- Not listed in annex II & III of the Cosmetic regulation EU n° 1223/2009, as amended on prohibited and/or restricted substances.
- Not listed on the positive list for preservers.
- Zinc oxide listed in Annex VI to the Cosmetic Regulation EC 1223/2009 as amended can be used as UV filter up to 25%. Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
- The use of zinc oxide as a color in cosmetic product is restricted for application where deep lung exposure is possible. When used as colorants, zinc oxide must be called CI 77947.
Zinc oxide in nano and non-nano form is allowed as UV filter up to 25%. For the nano-form, only products with the following characteristics are permitted:
- Purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total.
- Median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm
- Water solubility < 50 mg/L
- Uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.
Zano® 20 is fully in line with the approval and specifications outlined above
Global Regulatory compliance / suncare products
Zano® 20 Is compliant for use in sunscreen products globally with following restrictions:
Countries Maximum concentration (as ZnO) Additional restriction / info Europe 25% Restrict usage to applications that avoid
end-user's lung exposure by inhalationSouth Korea 25 % Not known Japan No Limit Not known China Not known Not known. Zinc oxide is listed in the
Inventory of Existing Cosmetics Ingredients China.USA 25 % Zano® 20 is registered with the US FDA with NDC code 15613-600 Canada 25 % Applicants are required to keep information
for record-keeping purposes when nano zinc
oxide is used in sunscreen products. This information is required to be made available
upon requestTaiwan 25 % Restrict usage to applications that avoid
end-user's lung exposure by inhalationAustralia No Limit Not known Brazil 25 % Not known
Technical Details & Test Data
- Designing Performance
When used as single UV filter, the Zano® (Plus) products will each provide specific SPF, UVA and transparency levels that will all comply to international UVA regulations and broad-spectrum claims.
When used as a single UV filter, SPF values of 30+ are easy to achieve and when designing SPF 50+ products, Zano® can be combined with different boosters or other UV filters.- Manufacturing Flow
- Zano® 20 is manufactured from high purity zinc oxide (100% from mineral origin).
- The manufacturing process for Zano® 20 includes thermal treatment after which the materials are packed.
- There are no additive added and there are no purification or sterilization (irradiation) steps involved.
- The manufacturing process is further free of solvents.
- Zano® 20 is manufactured and tested in compliance with GMP Part II / ICH Q7 requirements.
- Impurities
Chemicals impurities
Based on best of our knowledge, Zano® 20 is free of the following chemicals / impurities:
- Polyacrylic Aromatic Hydrocarbons
- Paraben
- Petrolatum
- Phosphate
- Silicone
- Latex
- Phthalates
- Pesticides
- Formaldehyde
- 1,4-Dioxane
- Ethylene Oxide
- Sulfates
- Oxybenzone
- PABA (para-aminobenzoic acid)
- Monomers
- Nitrosamines
- Amines
Heavy Metals
- Zano® 20 as zinc oxide has the following typical impurities profile. All trace impurities are non-intentionally added and mostly coming from the raw material used for the manufacturing of the Zano® materials
- This listed impurities profile from ICP-AES measurement is the result of a statistical monitoring of known impurities during the production of one year.
% Average Pb 0.0006 Cd 0.0001 Fe 0.0001 As 0.0000 Al 0.0002 Ni 0.0000 Cr 0.0001 - Moreover Copper (Cu), Antimony (Sb), Cobalt (Co), Manganese (Mn), Thallium (Tl) and Mercury (Hg) are routinely monitored in Zano® 20. The resulting analysis highlights that those elements are mostly on or below the detection limit of the ICP-AES technique of 1 ppm.
Safety & Health
- Toxicological Profile
- Dermal irritation: No signs of corrosivity or irritation have been observed in standard regulatory dermal irritation and corrosivity tests.
- Eye irritation: No signs of eye irritation has been observed in standard regulatory tests.
- Skin sensitization: Zinc oxide is not a skin sensitizer.
Packaging & Availability
- Packaging Type
Storage & Handling
- Shelf Life
- 24 Months
- Storage Information
Keep in closed container, out of humidity and sun/light exposure.