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All Containers›Shop by use case›Lip care›Cosmetic or drug›The 60 percent rule, and why a tube is specialShop all lip care →
Cosmetic or drug

The 60 percent rule, and why a tube is special

By Dwight Davis, Founder

Updated

On this page5

There is one place in this regulation where the size of the container changes what the label is allowed to be, and lip balm lands on it almost by definition.

The rule

21 CFR 201.66(d)(10): where the Drug Facts labeling would require more than 60 percent of the total surface area available to bear labeling, a modified format may be used.

In deciding whether the 60 percent threshold is crossed, the uses listed are limited to the minimum required by the applicable monograph.

So it is a measurement, not a judgment. Label area, panel area, a ratio.

Why lip balm hits it

A standard twist tube gives you a label perhaps 55 by 55 millimeters wrapped round a narrow cylinder. A full-format Drug Facts panel does not fit on that alongside a brand, an identity, a net quantity and an ingredient list.

Which is why nearly every medicated lip balm on a shelf uses the modified format, and why the category is named in the discussion of the provision.

What the modified format allows

Smaller minimum type for the "Drug Facts (continued)" title and the headings, a floor of 7 point.

Less leading, provided ascenders and descenders do not touch.

More than one bulleted statement on a horizontal line, and bullets that need not align vertically.

The box or enclosure may be omitted where color contrast sets the panel off instead.

It is real relief and it is not unlimited. The content does not shrink; the typography does.

The container is now a compliance decision

This is the point worth carrying out of the section. Choosing a smaller tube can put you over the 60 percent threshold, and choosing a larger one can put you under it. A two-panel label, an extended-content label or a small carton all change the total surface area available to bear labeling.

So on a drug-side product the container is chosen against the label, not the other way round. Work out the panel first, measure what the tube gives you, and let that decide the size, which is the reverse of how the decision is usually made.

References

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
21 CFR 347.50, Labeling of skin protectant drug products. Statement of identity is "Skin protectant", "lip protectant" or "lip balm"; the indication for a lip protectant is the prescribed phrase "temporarily protects and helps relieve chapped or cracked lips", with defined optional additions. 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.