Tools and directories

The words, in the order you meet them

By Dwight Davis, Founder

Updated October 2026

On this page5

The formula The process The failures The regulation References

Terms as you encounter them, rather than alphabetically.

The formula

Anhydrous. Containing no water. Why a lip balm needs no preservative.

Ratio. Wax to butter to liquid oil, by weight, as percentages of the whole.

Slip. How readily the balm glides. A property of the liquid oil.

Deposit. How much product transfers to the lip.

INCI. The naming system used for cosmetic ingredient declaration. Cera Alba, not beeswax.

The process

Melt temperature. High enough to destroy all existing crystal structure.

Pour temperature. Lower, where the melt fills cleanly without excessive shrinkage.

Second pour. Topping the tubes after the shrink dimple has formed.

Reference set. First, middle and last tube of a run, kept for comparison.

The failures

Bloom. White surface film from fat recrystallizing after warmth. Cosmetic.

Graining. Gritty texture from large crystals, caused by incomplete melting or slow cooling. Not recoverable in the tube.

Sweating. Oil separating to the surface. A formula fault.

Drag. Failure to glide. Too much wax, or the wrong one.

The regulation

Lip protectant drug product. Defined in 21 CFR 347.3 as one that temporarily prevents dryness and helps relieve chapping of the lips; "traditionally called lip balm."

Monograph. The conditions under which a class of OTC drug is generally recognized as safe and effective. 21 CFR 347 for skin protectants; OTC Monograph M020 for sunscreen.

Drug Facts. The standardized OTC drug labeling panel, 21 CFR 201.66.

The 60 percent rule. 201.66(d)(10): a modified panel format where the full one would need more than 60 percent of the available labeling surface.

NDC. The labeler code and product identifier an OTC drug carries.

cGMP. 21 CFR 210 and 211. Applies to drug products at any business size.

MoCRA. The cosmetics registration and listing regime, with small-business exemptions that do not extend to safety substantiation.

References

21 CFR 347.3, Definitions. "Lip protectant drug product. A drug product that temporarily prevents dryness and helps relieve chapping of the exposed surfaces of the lips; traditionally called ‘lip balm.’" 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

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

US Food and Drug Administration. Registration & Listing of Cosmetic Product Facilities and Products under MoCRA, including the small-business exemptions and what they do not cover. fda.gov

21 CFR Parts 210 and 211, Current Good Manufacturing Practice for finished pharmaceuticals, which apply to OTC monograph drug products with no exemption based on the size of the business. 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.