Cosmetic or drug

Adding SPF

Updated October 2026

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A different monograph Testing, not calculation The label changes again Whether to do it at all References

An SPF lip balm is the most requested product in the category and the hardest one for a small maker to produce legally.

A different monograph

Sunscreens are covered by OTC Monograph M020, a deemed final administrative order that carried forward the conditions published in 1999 as 21 CFR part 352. Since the CARES Act it is amended by administrative order rather than by rulemaking, and several provisions, labeling and maximum SPF among them, are still being worked through.

What that means in practice: the requirements are live and in force, and the ground under some of the detail is moving. Check the current order rather than a summary written a few years ago.

A combination of a skin protectant and a sunscreen is dealt with in 347.20(d) together with the sunscreen monograph, and that combination is what a medicated SPF lip balm actually is.

Testing, not calculation

This is the part that ends most home attempts. An SPF value is a measured result, not a number you derive from the percentage of zinc oxide you added. It comes from testing to the monograph method, on human subjects, at a laboratory.

Which costs real money per formula, and applies per formula: change the wax, the oil ratio or the pigment load and the tested value no longer describes what you are selling.

Supplier literature quoting an SPF for an ingredient is describing that ingredient in somebody else's tested formula. It is not your result and you may not print it.

The label changes again

Drug Facts with the sunscreen active and its purpose, the SPF value, the prescribed uses and warnings, directions including reapplication, and where applicable the broad spectrum statement.

On a lip balm tube, with a skin protectant active as well, this is the tightest label in the category, and the small-package provision is doing all the work.

Whether to do it at all

An honest read: SPF is a real product with real demand and it is a poor first product. The testing cost lands before the first sale, the formula is locked by it, and the manufacturing standard is cGMP.

Makers who want to serve that demand usually do it later, or through a co-packer already running tested sunscreen formulas, which is a legitimate route and worth pricing early.

References

FDA, OTC Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use, the deemed final administrative order carrying forward the 1999 21 CFR part 352 conditions, amended by administrative order under the CARES Act rather than by rulemaking. fda.gov

21 CFR 347.20, Permitted combinations of active ingredients. Which monograph actives may be combined, and with what labeling. Combinations of a skin protectant with a sunscreen are addressed in 347.20(d) and in the sunscreen monograph. ecfr.gov

21 CFR 201.66, Format and content requirements for OTC drug product labeling (the Drug Facts panel). Paragraph (d)(10) permits a modified format where the panel would otherwise require more than 60 percent of the total surface area available to bear labeling. ecfr.gov

Written from the federal regulation and FDA guidance named on each page, not from a laboratory or a legal practice. Whether a particular formula and a particular label make a cosmetic or a drug is a determination about your product, and this is not that determination.