Sunscreen is a drug, not a cosmetic
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What that means on the label
A Drug Facts panel rather than the cosmetic ingredient listing: active ingredients with their purpose, uses, warnings, directions and inactive ingredients, in the prescribed order and format. It looks like the back of a packet of painkillers because it is the same system.
The regulation is written for this product specifically
Section 201.327 is titled over-the-counter sunscreen drug products, required labeling based on effectiveness testing. The phrase at the end is the important one: the label follows from tests, not from what is in the jar.
Directions are mandatory and specific
How much to apply, how long before exposure, how often to reapply, and what else to do to limit exposure. These are regulated content rather than advice you compose, and they take up real space on a small bottle.
Which changes the whole product development order
A cosmetic can be formulated, labeled and sold. A sunscreen has to be formulated, tested, and then labeled with what the testing produced. Reformulating afterwards sends you back to the testing, which is why sunscreen ranges change slowly.
It also changes who can make it
Drug manufacturing carries its own expectations around facilities and records, well beyond what a cosmetic maker is used to. That is a bigger practical barrier for a small producer than the testing cost.
The adjacent products are not drugs
An after sun lotion sitting next to it on the same shelf, in the same bottle, is a cosmetic. The regime follows the product and the claims, not the aisle.
Imported and private label products carry it too
Buying a finished sunscreen to sell under your own brand does not move the drug requirements elsewhere; it makes you responsible for a drug product. The testing and the panel belong to whoever is named on the label.