Knowde Enhanced TDS
Identification & Functionality
- Chemical Family
- Chemical Name
- INCI Name
- Ingredient Origin
- Cosmetic Ingredients Functions
- 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
- Odor
- Odorless
- Appearance
- White powder
- EINECS No.
- 215-222-5, 220-941-2
- Typical Properties
- Heavy Metals
| Value | Units | Test Method / Conditions | |
| Critical Wavelength | 373.0 | nm | — |
| In-Vitro | 14.8 | — | UVA-PF (ISO-24443) |
| In-Vivo SPF | 33.2 | — | — |
| Triethoxycaprylylsilane (Nominal Content) | 3.8 | % wt | — |
| SPF | approx. 1.6 | Units | — |
| Zinc Oxide (Nominal Content) | 96.2 | % wt | — |
| UVA-PF | approx. 0.75 | Units | — |
| Value | Units | Test Method / Conditions | |
| Arsenic Content | max. 2 | ppm | — |
| Cadmium Content | max. 10 | ppm | — |
| Lead Oxide Content | max. 10 | ppm | — |
Regulatory & Compliance
- Certifications & Compliance
- COSMOS
Not certified
- Statements
Allergens
Regulation (EC) n°1223/2009 as amended: Zano® 10 Plus is free of allergens.
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® 10 Plus does not contain and/or is manufactured from Genetic Manipulated Organisms (GMO).
Microbial stability
Zano® 10 Plus being mostly a zinc oxide (CAS: 1314-13-2) powder, is free of micro-organisms. Zinc oxide is known to present bacteriostatic properties.
BSE/TSE
Zano® 10 Plus is free of animal derived ingredients. As a result, Zano® 10 Plus is free of Transmissible Spongiform Encephalopathy (TSE), including Bovine Spongiform Encephalopathy (BSE).
Animal testing
Zano® 10 Plus has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of EverCare.
Residual Solvent
Zano® 10 Plus process results to potential residual solvents as follows.
Solvent Class Specification limit Ethanol III Trace level. Max 1% based on Loss on drying (2 hours @ 105°)
– Total ethanol and moistureVOC
The only possible trace of residual solvent in Zano® 10 Plus is ethanol. Zano® 10 Plus is totally free of any other Volatile Organic Compounds (VOC).
SVHC
Zano® 10 Plus 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 updated 8th of July 2021, in a concentration above 0.1%.
CMR
Zano® 10 Plus is not manufactured using substances classified as CMR (Carcinogenic, Mutagenic, Toxic for reproduction). Moreover, under normal and foreseeable circumstances Zano® 10 Plus would not be expected to contain any substances classified as CMR above generally acknowledged regulatory standards or technical limit guidelines.
CITES
Zano® 10 Plus 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® 10 Plus:
- During the surface treatment, it should not be excluded that some trace of ethanol is still present in the Zano® 10 Plus. The trace level is specified at maximum 1% based on loss on drying (2 hours @105°c), total of moisture and Ethanol.
- Does not contain nor come into contact with animal derived materials during manufacture and storage.
- Zano® 10 Plus is 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, limited. 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, byproduct 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® 10 Plus is consequently compliant with vegan standards.
Conflict Minerals
Zano® 10 Plus 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® 10 Plus are listed under the California Proposition 65.
- Moreover Zano® 10 prior coating typically contains trace impurities of cadmium < 10 ppm, lead oxide < 10 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® 10 Plus 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
- All the substances going into the composition of the Zano® 10 Plus are registered and compliant with current Reach regulations EC n° 1907/2006.
- Zano® 10 Plus is a zinc oxide with a surface treatment with the following composition:
Constituents CAS Registration
deadlineRole of EverCare in the
supply chainZinc Oxide 1314-13-2 2010 Manufacturer Triethoxycaprylylsilane 2943-75-1 2013 Down-stream user - 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.
- As a down-stream user, only supplier(s) of Triethoxycaprylylsilane with confirmed and effective REACH registration are used (based REACH registration number: 01-2119972313- 39).
FDA
- EZUF NL B.V is registered as drug establishment with F.E.I number 3016994900.
- Zano® 10 Plus is registered with the US FDA with the NDC code 15613-110.
- Zano® 10 Plus is compliant for OTC products on the US market.
- Cosmetic Regulations
Zano® 10 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® 10 Plus is fully in line with the approval and specifications outlined above.
Global Regulatory compliance / suncare products
Zano® 10 Plus 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® 10 Plus is registered with the US FDA with NDC code 15613-100 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.- Impurities
Chemicals impurities
Based on best of our knowledge, Zano® 10 Plus 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® 10 Plus, the zinc oxide prior to the surface treatment, 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® 10 Plus prior to surface treatement. The resulting analysis highlights that those elements are mostly on or below the detection limit of the ICP-AES technique of 1 ppm.
- Manufacturing Flow
- Zano® 10 is manufactured from high purity zinc oxide (100% from mineral origin).
- The manufacturing process for Zano® 10 Plus materials includes thermal treatment and sieving, followed up by a surface treatment after which the material is packed. There are no purification or sterilization (irradiation) steps involved.
- Zano® 10 Plus is manufactured and tested in compliance with GMP Part II / ICH Q7 requirements.
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 have been observed in standard regulatory tests.
- Skin sensitization: Zinc oxide is not a skin sensitizer.
Packaging & Availability
- Packaging Type
Storage & Handling
- Shelf Life
- 36 Months
- Storage Information
Keep in closed container, out of humidity and sun/light exposure.