Compliance
A sunscreen that cannot be registered is a sunscreen that cannot be sold.
Sunscreen is one of the most heavily regulated cosmetic categories because it makes a health claim. The requirements differ enough between markets that the same formula can be a cosmetic in one country and a drug in another.
Understanding this before formulation starts saves rework later. We build with the target market's rules in view from the beginning.
United States
Sunscreen is a drug
SPF claims make the product an OTC drug under the FDA monograph. Manufacturing, testing and labelling all follow drug rules, not cosmetic rules.
Read the detail →European Union
Nano labelling obligations
Cosmetic products fall under Regulation 1223/2009. Zinc oxide in nano form carries specific authorisation conditions and mandatory "(nano)" labelling.
Read the detail →China
Registration before sale
Cosmetics require filing or registration with the NMPA. Imported products follow a different route from domestically produced ones.
Read the detail →ASEAN
Harmonised directive
Ten member states implementing a common cosmetic directive, with notification procedures that differ country by country.
Read the detail →How we support registration
We prepare the material documentation behind your filing — composition, safety data, manufacturing information, and nano-specific technical data where applicable — and work with your regulatory team on the submission.
The marketing authorisation or product notification is held in the brand owner's name. That is correct legally and it is what you want commercially.