Hibiscus Phytocosméticos
Sunscreen and photoprotection
The longest regulatory route in the industry — and the category where the starting base decides the whole schedule.
Photoprotection is not developed like the rest of the portfolio. It is one of the nine product groups Anvisa keeps subject to registration, with prior review before any sale — and the claim the product is named after is a number measured in a test, not a description.
That changes two things at once: the schedule and the starting point. Starting from a base that has already been tested does not save you a step — it saves you the entire cycle of developing and substantiating a new base.
What changes compared with the other ranges
The difference that reorganises the schedule is regulatory. Most cosmetics are exempt from registration and reach the market through prior notification to Anvisa, within days. Sunscreen and children’s sunscreen are among the nine groups on the closed list in art. 34 of RDC 907/2024: they are subject to registration, with a full technical dossier, Anvisa review and publication in the Official Gazette before the first sale. Review time varies with complexity and usually runs to several months; registration is valid for ten years and renewable.
There is no shortcut here. Treating a sunscreen as a registration-exempt product is a health regulation offence, subject to penalties and to cancellation of the product’s regulatory status.
The second difference is subtler, and it is the one that decides where the formula starts. Every cosmetic needs safety and efficacy substantiation proportionate to what it promises — that is not unique to photoprotection. What changes here is the nature of the claim: SPF is a number, measured in a test on one specific formulation. It does not carry over on its own from one formula to another, and altering the base after the study can mean redoing the study. That is why, in photoprotection, choosing the starting base is a decision for the beginning of the project, not the middle.
The full guide to the process is in Anvisa cosmetics registration — worth reading before you lock a launch schedule.
This is Brazilian regulation. It describes what Anvisa requires in order to manufacture and sell in Brazil. Registration in the destination country rests with the importer, under its own health authority's rules.
Where we already have a base
We maintain in-house stick and BB cream bases with SPF 50 studies already run. Entering the category through one of those formats does not require developing and testing a base from scratch.
The important caveat. Whether the studies apply to the final product depends on how far it is customised and on the project's regulatory classification. The further the formula moves from the tested base, the closer the route gets to a new development — with the substantiation that requires.
That is exactly what we settle at the briefing, before any investment: what the base already solves and what your project will still need.
Photoprotection formats we produce
| Format | Minimum | Note |
|---|---|---|
| Stick | From 500 units | In-house base with SPF 50 studies |
| BB cream / tinted base | 20 kg per SKU | In-house base with SPF 50 studies |
| Cream, gel, lotion and serum | 20 kg per SKU | No tested base ready — feasibility assessed at the briefing |
Per-unit minimums are a starting reference: the exact number depends on the packaging the brand specifies, because that is what determines how much product fits in each piece. The capability matrix shows the full combination of format and product range.
Multifunctional is where the category grows
Much of the demand that reaches us is not for pure sunscreen: it is for a make-up or skincare product that also protects — a tinted stick, a BB cream, a tinted base. The commercial appeal is that of make-up or skincare; the SPF substantiation is not. The number on the label still depends on a test run on the formulation that leaves here.
The regulatory classification of these multifunctional products is decided case by case, with the regulatory specialist, based on which product group it falls under in the art. 34 list. It is the question to ask at the start of the project, because the answer changes the whole schedule — not the one you discover after the sample is approved.
Before we talk
Build your briefing in three answers
Three questions, and WhatsApp opens with the summary already written. The first reply you get comes with feasibility and lead time, instead of three more questions.
No data leaves this site: your answers become text inside your own message, and you can edit it before sending.
How the project runs
The flow is the same as the other ranges — up to 30 days from briefing to first sample and 10 working days of production, counted from the arrival of raw materials. What is added here is Anvisa’s review time, which varies with complexity and usually runs to several months.
No technical detail is exchanged before the NDA is signed. Regulatory work is part of what we deliver, from the technical dossier through to registration, in partnership with regulatory affairs specialists.
If you have not yet decided where the formula starts, the three development models explain what changes in time, investment and exclusivity on each route. If you already manufacture and are looking for photoprotection capacity, see contract manufacturing.
Looking to enter photoprotection?
Tell us the format and the SPF you have in mind — from there we can estimate schedule and regulatory route.