One product, several regimes
A sun protection product is one of the clearest examples of a category whose regulatory identity depends entirely on where it is sold. The formulation can be identical, the testing can be to the same international standards, and the classification can differ completely.
That has consequences beyond compliance paperwork. Classification determines whether the labelling is prescriptive or general, whether particular terms are defined, whether there is pre-market assessment, and how much freedom a manufacturer has in wording.
For anyone reading a pack, it explains why an imported product looks so different from a domestic one, and why copy written for one market causes problems in another.
| UK and EU | United States | Australia | |
|---|---|---|---|
| Classification | Cosmetic product | Over the counter drug | Therapeutic good for many products |
| Pre-market assessment | None | Regulated under the drug framework | A regulatory pathway applies |
| Labelling style | General obligations plus convention | Prescribed panel and format | National standard for sunscreens |
| Is broad spectrum defined | No | Yes, by critical wavelength | Addressed within the standard |
| Water resistance wording | Resistance claim with evidence held | Claim must state a tested duration | Addressed within the standard |
| Who carries obligations | The responsible person named on the pack | The manufacturer or distributor under drug rules | The sponsor under the therapeutic goods framework |
Framework of this publication. It describes how published rules and guidance fit together and is not a measurement, a survey or a study.
The United Kingdom and the European Union
Cosmetics. No pre-market approval. A responsible person holds a product information file with a safety assessment. Ultraviolet filters are controlled by a positive list. Claims are governed by general criteria rather than by prescribed wording, supplemented by the European Commission recommendation that produced the categories, the printed figures, the cap and the circled ultraviolet A mark.
The character of the regime is general obligation plus universal convention. Its strength is adaptability; its weakness is that a reader cannot tell which parts of the label are required and which are convention.
The United States
Over the counter drugs, regulated by the Food and Drug Administration. That classification produces a very different pack.
Labelling is prescriptive, with a Drug Facts panel setting out active ingredients, uses, warnings and directions in a specified format and order. Terms are defined: broad spectrum is available only to products meeting a critical wavelength criterion, and water resistance claims must state a tested duration rather than being made in the abstract. Wording implying complete protection is not available, and the vocabulary permitted for describing protection is constrained.
The result is a pack that tells a reader more about conditions and directions, in a fixed format, at the cost of flexibility and of a certain amount of readability.
Australia
Many sun protection products in Australia are therapeutic goods, regulated by the Therapeutic Goods Administration, with a national standard covering sunscreens. Products whose primary purpose is sun protection are treated differently from cosmetics that happen to contain an ultraviolet filter, and there is a regulatory pathway that products go through rather than a purely post-market system.
The Australian arrangement is the clearest example of a jurisdiction treating sun protection as a public health matter first and a cosmetic matter second, which is unsurprising given the ultraviolet conditions the population lives in.
Elsewhere
Other jurisdictions place the product in other categories, and the effect on labelling follows. Some treat sunscreens as a subset of drugs or health products with their own review pathway. Some operate cosmetic regimes closer to the European model. Some set their own maximum labelled factor.
We do not attempt a survey. A publication that does not print figures it cannot source should not attempt a comparative table of dozens of regimes, and businesses selling internationally take specialist advice as a matter of course.
What this means for wording
Three practical consequences follow, and each one produces recognisable problems.
Terms do not travel. Broad spectrum carries a defined test in one jurisdiction and no definition in another. Wording drafted where the term is defined arrives elsewhere with an authority it does not have, and wording drafted where it is undefined can be non-compliant where it is.
Maximum labelled figures differ. A cap on the printed factor is a labelling convention or rule of a particular market, and a product labelled above a local cap is a labelling problem rather than a product problem.
Prescribed panels do not translate. A Drug Facts panel on a British pack is not required, is not expected and can create confusion. Equally a British pack arriving in a prescriptive market lacks required elements.
The pattern that causes the most difficulty is the one that treats a single global artwork as the efficient option. It saves origination cost and produces packs that are wrong in most markets.
Cross border selling
The practical exposure has grown with online marketplaces. A product compliant where it was manufactured, shipped directly to a consumer in another jurisdiction, arrives with labelling designed for a different regime, no local responsible person and claims that may not be permitted.
For a reader, the useful signal is the one described in the responsible person and the product information file: a pack sold in Great Britain should carry the name and address of a responsible person established here. A pack without one has probably not been placed on the market through the ordinary route.
What does travel: the test methods
Amid the divergence there is one substantial area of agreement, and it is worth stating because it is easy to miss.
The measurement methods are largely international. The in vivo determination of the sun protection factor and the in vitro determination of ultraviolet A photoprotection are published as international standards, and their use is widespread across jurisdictions whatever the local classification of the product. A laboratory in one country running the same method as a laboratory in another produces results intended to be comparable.
This means the divergence between regimes is not usually about what is measured. It is about how the measurement is expressed, which words may accompany it, what else must appear alongside it and who carries the obligation. The physics is agreed; the vocabulary is not.
That is a reassuring fact for a reader looking at an imported pack, and a slightly deflating one for anyone hoping that a different regime implies better testing. In most cases it implies the same testing described differently.
Is one system better
It is tempting to prefer the prescriptive approach, since defined terms and a fixed panel remove ambiguity. The trade offs are real in both directions.
A prescriptive regime is clear, enforceable and slow to change, and its fixed panels are frequently unread. A general regime adapts quickly, places judgement on the business, and relies on enforcement that is less visible and on conventions that a reader cannot distinguish from rules.
This publication does not campaign for either. What it does insist on is that a reader should be able to find out which is which, which is the gap it exists to fill.
Maximum labelled figures and why they differ
One visible difference between markets is the highest figure a pack may display, and it is worth understanding as a labelling decision rather than as a statement about products.
Where a cap exists, its function is the same everywhere: to stop the numeral rising into a region where the difference in the fraction reaching skin is small, the measurement uncertainty is proportionally larger, and a doubling numeral would be read as a doubling benefit. That reasoning is set out in protection categories and why labels stop at 50.
Different jurisdictions have reached different answers about where to place the cap and how to express what lies above it, and some have not capped at all. A product tested at the same value can therefore appear with different figures in different markets, which looks like a difference in the product and is a difference in the labelling rule.
For a reader looking at an imported pack, the practical point is that a higher printed figure than British packs carry is not evidence of a better product. It is evidence of a different convention about where a scale should stop.
What to take from this
Cosmetic here, drug in the United States, therapeutic good in Australia. Classification determines whether labelling is prescriptive or general and whether terms are defined, so identical wording carries different weight in different markets and copy does not travel.