-
OTC Actives Testing for Sunscreen
I am working with a CM to manufacture a sunscreen product. We have already completed the FDA required UVB testing, resulting in an SPF 37, so we can claim SPF 35. The CM is validating a method for us to measure the active levels and is asking for a spec range for each active. Is there an industry standard used in this instance? I looked through the FDA’s website and could only find very vague answers. I know industry standard for batching is within 1% but does it need to be tighter for OTC actives since they are called out on pack?
Any advice would be much appreciated!
-
4 Replies
-
OTC Sunscreen actives are always +/- 10% of the Active amount. The assays aren’t that accurate, so you need every bit of that room.
-
Thank you so much!
-
The requirements for the +/- 10% for sunscreen actives aren’t in the sunscreen monograph or anywhere on the FDA website if you look for sunscreen information.
Where to find the regs for this, if you need them, is in the general requirements for all OTC drugs. A lot of people don’t realize that the general regulations also apply to sunscreens, because they’re not in the monograph - but they do.
-
What bobz said. Take the regulations very, very seriously. The FDA considers sunscreen to be just as much a drug as aspirin or cold medication. And if they coming poking around they DO NOT take kindly to the sentiment “Well it’s not a real drug”
Log in to reply.
