BASF Had to License Back the Molecule It Invented

FDA published a notice this morning announcing final order OTC000008-1, which removes aminobenzoic acid and trolamine salicylate from the sunscreen monograph. Both are now formally not GRASE.

The order also says, in the response to comments, that the agency "is not aware of any sunscreen drug products containing PABA or trolamine salicylate being marketed in the United States."

So the immediate supply consequence is nothing. The interesting part is what the list looks like on the other side of it.

Sixteen actives went into section 352.10 in the May 21, 1999 final monograph and stayed there, untouched, for twenty-seven years.

One was added in June. Two come off on September 11, 2027, when today's order takes effect, and the count lands at 15 (chart below).

A list that ends 2027 one entry shorter than it started in 1999 is a strange thing to call progress. The entry that went on is stranger.

What the Order Actually Does

The operative text is four lines long. It strikes paragraphs (a) aminobenzoic acid (PABA) and (p) trolamine salicylate from section M020.10, redesignates what is left, and rewrites the combination rules in M020.20(a) to match the new lettering.

Effective date is September 11, 2027, a full year out. On that date any product still carrying either ingredient becomes an unapproved new drug requiring an NDA under section 505.

Padimate O stays. It is octyl dimethyl PABA, and the order that strikes PABA over comments about contact dermatitis does not mention the ester at all.

FDA issued the proposed order behind this, OTC000008, on September 24, 2021. Today's document closes two of its proposals and defers everything else, and the agency's own footnote calls this "the first final order issued under this Order ID."

That is the part worth sitting with. Five years of docket produced a decision on the two ingredients nobody sells, and everything OTC000008 proposed to do to the actives your formulations actually run on is still sitting in the same unfinalized proposal.

Twenty-Seven Years, Then Six Hundred Days

Bemotrizinol got on the list by a different road entirely.

DSM Nutritional Products LLC filed a Tier 1 OTC monograph order request on September 23, 2024, asking FDA to add the ingredient at concentrations up to 6 percent. The final order, OTC000039, issued June 10, 2026, and took effect August 9, 2026.

That is 625 days from filing to final order. The agency's own proposal on the legacy actives has been open 1,813 days and is not finished (chart below).

The whole bemotrizinol clock started and stopped inside the OTC000008 clock. Same office, same monograph, same statute.

The difference is that one of them had a company paying for it.