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FDA registration
I am after some help , either links or answers to the following:
We are manufacturing a moisturizer with SPF 15 using only physical UV filters(ZnO and TiO2) If i want to sell this in the US, does this go under OTC or just cosmetics. What sort of regulations should i look under. For example in Australia, as long as it is SPF 15 or below, it is considered as moisturiser not sunscreen. Any help or guidance will be highly appreciated. Thanks -
15 Replies
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Any sunscreen in the US is an OTC. If you claim SPF, it is an OTC and you have to follow the monograph.
Relevant. https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-sunscreen-drug-products
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Thanks @Perry . Do you think it is possible to do it by myself (R&D chemist) or does it require a consultant better
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If you want to market and sell the product, hire a consultant to help you. If you want to become a manufacturer of sunscreen for other brands, then learn to do it yourself.
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The biggest requirement is probably money. You have to register your product and pay for some pretty extensive testing
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Thanks @Perry
IS there any link or document that i can follow to check on what acceptable and what not acceptable as claims for cosmetics -
Perry said:Any sunscreen in the US is an OTC. If you claim SPF, it is an OTC and you have to follow the monograph.
Relevant. https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-sunscreen-drug-products
Hey Perry,
how can I find a consultant ? or do you have a consultant that you could recommend? or do you offer this service? -
There are a number of testing labs that can do the requisite SPF, Broad Specturm and Water Resistance testing for you, depending on what you want to claim on your label.
In the US, Sunscreen products must be manufactured in an OTC-certified facility and there is additional testing required to validate manufacturing process and product stability.
All in all, it’s a pretty pricey endeavour, and with an SPF of only 15, is there some other aspects of your product that will entice consumers, because if what you have is yet another moisturizer with SPF 15 …
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@Rari you can write to this consultant (I worked with her for my OTC products, she is super reasonable
Melanie Cummings <melanie@repertoireconsulting.com>
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@MarkBroussard
Thanks for your reply.
Actually we do have a full range of products. This moisturizer is just one of them and i’m asking because i’m confused is it cosmetic or OTC.
Do you have any clue how does “GRASE” formulas work. -
@Shams This may be of interest (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=700.35). -
@ozgirl for this. I have gone through it and what i understood is according to this my product can be considered as GRASE, but my consultant-haven’t agreed with them though- says no, i still have to apply for new drug application. Not sure is it because they want to complicate it to get the job or because this is the truth.i have a moisturizer with SPF, I use only zinc oxide at 21%, i am not using any colorants nor any prohibited substances that FDA list.
Do you have any idea about this case. Thaks -
The maximum allowed use of ZnO in sunscreens in the US is 25% and that should give you an SPF in the range 30 - 50, but it all depends on what else is in your formula.
GRAS means Generally Regarded As Safe & Effective. If ZnO is the only sunscreen active ingredient in your formula, it should be GRASE and an OTC drug product. Unless there is something that is not revealed in your description of your product, you should fall under the FDA Sunscreen Monograph and would not need to file a new drug application.
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@MarkBroussard Much appreciated Mark.
I literally have nothing else but some emollients, emulsifiers and extracts.
So i don’t need NDA. Do i still need to list it though and register my establishment. -
@MarkBroussard Sorry i wrote this before i saw the other post where you made it so clear to me. Thanks again
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