Regulatory Open Forum

Hi folks.

Interesting hypothetical crossed my desk this afternoon and I was wondering if any of you would be willing and able to assist me in providing an answer to someone on the label claims for an OTC SPF product in the US.

Hypothetical - Sunscreen product has a planned SPF 40 claim expected based on formulation and on the prior experience with this particular combination of allowed OTC sunscreen monograph active agents.  When the testing is completed an SPF 43 is obtained.  The marketer is not looking to claim anything specifically over SPF 40 and instead wants to claim "SPF 40+" on the PDP.

As I read the requirements (and I am also looking at recent FDA statements that would allow for products with an SPF 50 to be specifically claimed on PDP) I interpret the current result as requiring either the specific value of the SPF test (i.e., SPF 43) or an allowed value claim of SPF 40.  I don't believe that SPF 40+ is an acceptable claim in this instance because the monograph states that you are expected to report the actual claim until you reach the maximum claimable threshold of SPF 50.

The marketer has told me (and pointed out) about several current products on the market using the "SPF XX+" language where XX can be 30, 40, 45, or 50.  My initial thought on this point was that the original final monograph from 1999 had capped the allowed SPF claim at 30 and that these companies were just willing to take a bit of a chance until the monograph was formally finalized and the stay of enforcement was formally lifted by FDA.  But I am second-guessing myself now that I am seeing such a wide range of these types of claims.

I believe that claiming SPF 40 when data would support SPF 43 is fully acceptable.  I also believe that when the data supports SPF 43 you can make the absolute claim of SPF 43.  But I am trying to determine if you can make an SPF 40+ claim when your product shows SPF 43 under the regulations.  Again, assuming that FDA would accept up to an SPF 50 claim on your product.

Any help would really be appreciated from my friends on here!  Thanks in advance!

Hi folks.

Interesting hypothetical crossed my desk this afternoon and I was wondering if any of you would be willing and able to assist me in providing an answer to someone on the label claims for an OTC SPF product in the US.

Hypothetical - Sunscreen product has a planned SPF 40 claim expected based on formulation and on the prior experience with this particular combination of allowed OTC sunscreen monograph active agents.  When the testing is completed an SPF 43 is obtained.  The marketer is not looking to claim anything specifically over SPF 40 and instead wants to claim "SPF 40+" on the PDP.

As I read the requirements (and I am also looking at recent FDA statements that would allow for products with an SPF 50 to be specifically claimed on PDP) I interpret the current result as requiring either the specific value of the SPF test (i.e., SPF 43) or an allowed value claim of SPF 40.  I don't believe that SPF 40+ is an acceptable claim in this instance because the monograph states that you are expected to report the actual claim until you reach the maximum claimable threshold of SPF 50.

The marketer has told me (and pointed out) about several current products on the market using the "SPF XX+" language where XX can be 30, 40, 45, or 50.  My initial thought on this point was that the original final monograph from 1999 had capped the allowed SPF claim at 30 and that these companies were just willing to take a bit of a chance until the monograph was formally finalized and the stay of enforcement was formally lifted by FDA.  But I am second-guessing myself now that I am seeing such a wide range of these types of claims.

I believe that claiming SPF 40 when data would support SPF 43 is fully acceptable.  I also believe that when the data supports SPF 43 you can make the absolute claim of SPF 43.  But I am trying to determine if you can make an SPF 40+ claim when your product shows SPF 43 under the regulations.  Again, assuming that FDA would accept up to an SPF 50 claim on your product.

Any help would really be appreciated from my friends on here!  Thanks in advance!