Parapharmacy.org

A reference on parapharmacy in Europe

Ingredients

Zinc oxide

Zinc oxide is an inorganic UV filter authorised in EU sunscreens under Annex VI of Regulation (EC) No 1223/2009. It is one of the two principal mineral UV filters used in European parapharmacy sunscreens, alongside titanium dioxide.

At a glance

INCI name
Zinc Oxide; Zinc Oxide (nano) when in nanomaterial form
Chemical formula
ZnO
CAS number
1314-13-2
Regulatory class
UV filter authorised under Annex VI of Regulation (EC) No 1223/2009 (entry 30 in the non-nano form and a separate entry for the nano form), with specific conditions; also used as a colorant and as a skin-conditioning agent in other cosmetic contexts
Cosmetic function
UV filter (broad-spectrum); also sunscreen, skin-protecting

What it is

Zinc oxide is an inorganic, white, water-insoluble compound used in cosmetics as a UV filter and a pigment. It absorbs and scatters ultraviolet radiation across a broad-spectrum range covering UVA and UVB wavelengths, which is the basis of its sun-protection function. It is also used in nappy-rash creams and in some powder cosmetics, where it contributes both protection and a degree of opacity.

How it is used in parapharmacy products

Zinc oxide appears in EU sunscreens as a labelled UV filter, often in combination with other authorised filters from Annex VI of the Cosmetic Regulation to achieve the required broad-spectrum protection and the SPF and UVA-protection performance demanded by ISO test methods. The maximum concentration permitted is set in the Annex; the current EUR-Lex text is the authoritative source.

Two forms of zinc oxide are listed in Annex VI: the non-nano form and the nano form (Zinc Oxide (nano)). The latter has its own entry with specific conditions, adopted following SCCS opinions on the safety of zinc oxide nanomaterials in finished cosmetic products. The nano form must be declared with the suffix "(nano)" on the ingredients list under Article 19(1)(g) of the Regulation.

Outside sunscreens, zinc oxide is used in infant-care creams targeting nappy-area skin irritation; in this context, depending on intended use and claims, the product can be a cosmetic or a medical device, or in some cases a medicinal product. Regulatory classification follows the presentation and function tests described in the EU instruments.

Regulatory status

Zinc oxide is authorised as a UV filter in Annex VI of Regulation (EC) No 1223/2009, with conditions including a maximum concentration, restrictions on use in spray applications (because of concerns about respiratory exposure to nano-zinc-oxide aerosol), and other conditions specific to the nano form. The SCCS has published opinions evaluating the use of zinc oxide as a UV filter and as a nanomaterial; these opinions are the scientific basis for the Annex conditions and are publicly available on the Commission's SCCS pages.

Evidence summary

Zinc oxide's ability to attenuate UVA and UVB radiation in a finished cosmetic vehicle is well-established physically. Its in-vivo protection performance in a sunscreen depends on the formulation, the dose applied per unit skin area, and the test methodology (ISO 24444 for SPF and ISO 24443 for UVA-PF). Comparative effectiveness against other UV-filter combinations is a question of finished-product testing, not of the ingredient in isolation.

Safety and known considerations

Topical zinc oxide on intact skin is generally well tolerated, with allergic contact dermatitis rare. The principal safety question on which SCCS opinions have focused is the use of the nanomaterial form, particularly in spray products, where there is a concern about inhalational exposure to the aerosolised nanoparticles. The Annex VI conditions for Zinc Oxide (nano) reflect these considerations and may include restrictions on aerosol formulations. Products containing nanomaterials are notified to the CPNP with specific nanomaterial fields completed by the responsible person under Article 16 of the Regulation.

References & further reading

  1. Regulation (EC) No 1223/2009, Annex VI (UV filters) — consolidated text on EUR-Lex: eur-lex.europa.eu.
  2. SCCS opinions on Zinc Oxide and Zinc Oxide (nano): health.ec.europa.eu/scientific-committees.
  3. ISO 24444:2019 (SPF determination) and ISO 24443:2021 (UVA-PF determination): iso.org.

Last reviewed: May 2026.