• DRUG FACTS

    Posted by JD on May 26, 2014 at 4:18 pm

    Hi,

    Does anyone know if we have to list our sunscreens as “Active Drugs”?   I am not making a claim but I do have benzophenone 3 and Octyl methoxy cinnamate in my formula as well as titanium dioxide. There is no “SPF” rating so do i need to list as “Active” ingredients?
    Thanks
    JD replied 9 years, 10 months ago 6 Members · 12 Replies
  • 12 Replies
  • Bobzchemist

    Member
    May 27, 2014 at 9:54 am

    Grey area. Just listing those materials on your label could be enough to trigger the drug regulations. You need to look up the exact regulations for using sunscreens to only protect your product, but if I recall correctly, in order to avoid SPF testing, etc., your packaging needs a statement like: “Benzophenone 3 and Octyl methoxy cinnamate are present only to preserve the integrity of this product. There are not enough of these materials in this product to provide any sun protection.”

  • Bobzchemist

    Member
    May 27, 2014 at 9:56 am

    And of course, you must never, ever even imply that your product protects against the sun’s radiation in any way on the package or in any literature or advertising.

  • JD

    Member
    May 27, 2014 at 11:48 pm

    That is a buzz kill. well, better to be safe than sorry. i better get back to changing my label.

    thank you!
  • DavidW

    Member
    May 31, 2014 at 6:04 pm

    In my opinion if you are not making a claim then you do not need to list them as actives.  We use sunscreens in some products that are not intended to be SPF products and therefore are not listed as actives.

  • cosmochem

    Member
    May 31, 2014 at 6:33 pm

    I do agree with David that you need to put a Drug Facts only when you claim an SPF value on it. Claiming SPF turns cosmetic into drug.

  • JD

    Member
    August 26, 2014 at 2:08 am

    Much appreciated and will remove those label options. Thank you!

    Ps..
    Can I use SPF drug facts if I use a posted formula from BASF or any other chemical company that gives their formula out? Can I claim that SPF?

  • Bobzchemist

    Member
    August 26, 2014 at 9:29 am

    Not in the US, at least not without testing the in-vivo SPF yourself.

  • OldPerry

    Member
    August 26, 2014 at 12:06 pm

    Right.  If you make the SPF claim, you have to demonstrate that it’s true via testing.  Pointing regulators to the BASF formula is not adequate for proof.

  • Bobzchemist

    Member
    August 26, 2014 at 1:59 pm

    There is a caveat here, though. 

    BASF, or a consultant, or a private label company, etc. can produce a SPF formula, do ALL the testing, provide the test results and data to you, and then license the formula to you. In that case, then as long as you do not change a single thing about that formula, you do not have to repeat the tests. When the FDA comes to inspect, you can show them the test data, etc. that has been provided to you.
    But, as Perry says, you can’t just point to a published formula and say “I did it just like that” and have the FDA be OK with it - you have to be able to show that, even if you didn’t perform or contract the testing yourself, it was done on your behalf. That’s why licensing the formula is a key point.
  • JD

    Member
    August 27, 2014 at 2:23 pm

    Those are both great commments! thank you! And I suppose companies don’t always offer test results,data and license just because you request it? Or do they?

    Question, if you formulate to those exact specifications and they are willing to send test results and data but no license, would that satisfy the FDA, and I could use the tested SPF rating? I would think license is just the business end not the formulation specifications and testing data?

  • RawMaterialGirl

    Member
    August 27, 2014 at 4:27 pm

    @bobzchemist is correct - grey area. If ingredients have dual functions, there should be a “max value” as to what you can use the ingredient for one use; anything above that use makes it an active ingredient. I also believe that if the ingredient is adding more than an SPF level of two, you have to list it as an active ingredient.

  • JD

    Member
    August 29, 2014 at 2:30 am

    Ok. Thank you. I’m not going there then. I’ll just not make mention of SPF.

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