Zano® 10

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.

Certified

Allergens

Regulation (EC) n°1223/2009 as amended: Zano® 10 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 does not contain and/or is manufactured from Genetic Manipulated Organisms (GMO).

Microbial stability

Zano® 10 being a zinc oxide (CAS: 1314-13-2) powder, is free of microorganisms. Zinc Oxide is known to present bacteriostatic properties.

BSE/TSE

Zano® 10 is free of animal derived ingredients. As a result, Zano® 10 is free of Transmissible Spongiform Encephalopathy (TSE), including Bovine Spongiform Encephalopathy (BSE).

Animal testing

Zano® 10 has not been the subject of animal testing or retesting for cosmetic purposes by or on behalf of EverCare.

VOC

Zano® 10 is free of Volatile Organic Compounds.

Residual Solvent

Zano® 10 is produced with a process free of solvent. Zano® 10 is consequently free of residual solvents.

SVHC

Zano® 10 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® 10 is not manufactured using substances classified as CMR (Carcinogenic, Mutagenic, Toxic for reproduction). Moreover, under normal and foreseeable circumstances Zano® 10 would not be expected to contain any substances classified as CMR above generally acknowledged regulatory standards or technical limit guidelines.

Endocrine distruptor.

Zano® 10 is not a Endocrine distruptor (ED). Zano® 10 is free of ED.

CITES

Zano® 10 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:

• 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, 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 is consequently compliant with vegan standards.

Conflict Minerals

Zano® 10 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 are listed under the California Proposition 65.
• Moreover Zano® 10 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 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.

REACH

• Zano® 10 (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® 10 is registered with the US FDA with the NDC code 15613-100.
• Zano® 10 is compliant for OTC products on the US market.

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 is fully in line with the approval and specifications outlined above.

Global Regulatory compliance / suncare products

Zano® 10 Is compliant for use in sunscreen products globally with following restrictions:

Keep in closed container, out of humidity and sun/light exposure.