Can block a launchUnited StatesSuncare

Sunscreen is a drug in the US, not a cosmetic

FDA regulates sunscreens as it does other nonprescription drug products, holding them to safety and effectiveness standards rather than treating them as cosmetics.

A Korean SPF product crosses the border as a drug, which is a different filing, a different label and a different timeline from the rest of your range.

Exceptions and limits

The Consumer Goods (Cosmetics) Information Standard 2020 does not apply to therapeutic goods within the meaning of the Therapeutic Goods Act 1989, and it applies to cosmetic products manufactured in or imported into Australia after the end of 180 days from its commencement.
Korea’s Cosmetics Act defines functional cosmetics as a closed list of five effects, and a product sold for any of them must first undergo an examination by the Minister of Food and Drug Safety, or have a report submitted to the Minister on its safety and effectiveness, before it may be sold.
Korea’s Cosmetics Act defines a class of functional cosmetics that includes products aiding in protecting the skin from ultraviolet rays, and a responsible seller who manufactures or imports one must undergo an evaluation by the Minister of Food and Drug Safety or file a report on its safety and effectiveness, against a published review period of sixty days and a stated fee of 189,000 KRW.
FDA added bemotrizinol as a permitted sunscreen active ingredient in June 2026, widening the filter set available to sunscreens sold in the United States.
Of 8 beauty product pages selling into the United States that advertise an SPF value, 1 publishes a Drug Facts panel and 2 name an active ingredient, the two elements that distinguish an over-the-counter drug label from marketing copy, while 0 carry any warning text at all.

95 of a possible 97Tier A, primary document or measured outcome. Nothing at this tier is allowed past 97, however good it looks.

Verified August 4, 2026Rechecked every 180 days, next by January 31, 2027.

Constraint

Held since August 4, 2026A rule, law or policy that limits what you may do or say. The earliest date we are willing to say this held. It may well have been true before that; we do not backdate a record past the evidence we have read. Supported, version 1.

This entry is wrong if

FDA reclassifies sunscreens as cosmetics, or states they are not subject to nonprescription drug requirements.

Written before the record was published, not after. If you can show this, send it to hello@tryorbt.com and the correction goes on the record with the entry.

Evidence

Tier Aregulation
U.S. Food and Drug Administration: Sunscreen: How to Help Protect Your Skin from the Sun
Just as it does with other nonprescription drug products, FDA regulates sunscreens to ensure they meet safety and effectiveness standards.
Read 2026-08-04 · Public domain · page hash 3e65c9483628

History

v1createdAugust 4, 2026
Initial entry from primary regulator text, read 2026-08-04.

Append-only. Nothing in this list is edited or removed once written, including the entries that record our own mistakes. Every change to every record is on the corrections page, and the same log is in entries.json under revisions.

suncare
spf
otc-drug
market-entry
k-beauty

Cite this entry

“Sunscreen is a drug in the US, not a cosmetic”, The Orbt Market Index 0.1.0, entry omr:us:sunscreen-regulated-as-nonprescription-drug, retrieved September 9, 2026, https://tryorbt.com/markets/entry/us--sunscreen-regulated-as-nonprescription-drug. Dataset: https://doi.org/10.5281/zenodo.22679129

Orbt, "Sunscreen is a drug in the US, not a cosmetic," Orbt Market Index, entry omr:us:sunscreen-regulated-as-nonprescription-drug, verified August 4, 2026, https://tryorbt.com/markets/entry/us--sunscreen-regulated-as-nonprescription-drug.

@misc{orbt-us-sunscreen-regulated-as-nonprescription-drug,
  title        = {Sunscreen is a drug in the US, not a cosmetic},
  author       = {{Orbt}},
  year         = {2026},
  doi          = {10.5281/zenodo.22679129},
  note         = {The Orbt Market Index 0.1.0 (dataset DOI 10.5281/zenodo.22679129), entry omr:us:sunscreen-regulated-as-nonprescription-drug. Verified 2026-08-04},
  howpublished = {\url{https://tryorbt.com/markets/entry/us--sunscreen-regulated-as-nonprescription-drug}},
  license      = {Orbt Index Public Licence. Free to quote and cite; not to redistribute}
}

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