Formulating sunscreens with melatonin - acceptable in EU?

edited June 2014 in Formulating
A cosmetic scientist I spoke to mentioned that if you formulate sunscreen product with melatonin as one of the ingredients, the sunscreen would be viewed as a drug in the EU. Is this correct? 

I read the SCCS opinion on melatonin and from what I understand it would only be viewed as a drug if it's formulated in haircare products because it helps with hair growth and also if it's in medicines used to treat insomnia and other sleep disorders. 

Your thoughts on this matter would be greatly appreciated!

Thank you!


  • I disagree; if you don't make any medical claims related to melatonin, and the final product doesn't produce any physiological effects due to melatonin, the product can't reasonably be called a medicine just because it contains melatonin

    and unlike in the USA, suncreens are not classified as medicines or borderline medicines in Europe

    to my mind, the biggest point of contention in using melatonin will be finding enough toxicology data to prove that it's safe for use in leave-on skin products

    UK based formulation chemist. Strongest subjects: hair styling, hair bleaches, hair dyes (oxidative and non-oxidative) I know some stuff about: EU regulations, emulsions (O/W and W/O), toothpaste, mouthwash, shampoos, other toiletries
  • Thank you so much for clarifying that for me Bill!
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