United States (MoCRA)

Using INCI Names in Your FDA Product Listing

A practical walkthrough of entering ingredients by INCI name in a MoCRA product listing, including how to handle trade-secret fragrance components.

Diane R.4 min read

The part of a MoCRA product listing that trips people up isn't the facility registration or the responsible person field. It's staring at a formula sheet full of supplier trade names and realizing none of them are what the listing actually wants from you.

MoCRA requires facility registration and product listing with the FDA, along with a named responsible person, safety substantiation, and adverse event recordkeeping. The listing itself wants ingredients identified in a standardized way, and that standardized way is INCI nomenclature, the same naming system used across most of the world's cosmetic regulatory systems. Water is Aqua everywhere, not "purified water" or your supplier's bottling name for it.

Start by separating trade names from INCI names

Every raw material you buy has at least two names attached to it: whatever the supplier calls it on their invoice or spec sheet, and its actual INCI designation. Your formula sheet from a supplier might say "HydraSilk 200" or "EcoPreserve Blend," and neither of those means anything to a listing that expects standardized nomenclature. The supplier's technical data sheet or SDS is where you find the real INCI names underneath the trade name, usually in the composition section.

Do this ingredient by ingredient, and do not guess based on what a product name implies. A preservative blend with a nature-themed trade name is not necessarily what it sounds like. Pull the actual INCI names from the documentation every time.

Expanding supplier blends

Trade name products are frequently blends of several components, and your listing needs the actual ingredients, not the blend's marketing name. If a supplier sells "PreservEco 5" as a blend of phenoxyethanol and ethylhexylglycerin, your listing should show those two INCI names as separate ingredients, not "PreservEco 5" as a single line.

This matters even more when you are also tracking concentration for safety substantiation. If PreservEco 5 is used at 1% in your formula and its own documentation shows it is 80% phenoxyethanol and 20% ethylhexylglycerin, then your finished product actually contains 0.8% phenoxyethanol and 0.2% ethylhexylglycerin. Multiply the component percentage by the blend's use level every time. Skipping this step is one of the most common ways a percentage ends up wrong in a filing.

Handling fragrance as a trade secret

Fragrance is where INCI naming gets genuinely different from every other ingredient category. A fragrance house will not hand you the full formula of "Blossom Accord No. 4," and you are not expected to reverse-engineer it. The convention across most regulatory systems, including in listings that follow INCI practice, is that the fragrance blend itself is listed under the generic term for a fragrance mixture, while any individual components that carry their own disclosure requirements, like known allergens above a threshold, get named individually alongside it.

Practically, this means:

  1. List the fragrance or flavor as a mixture using the standard generic term for it.
  2. Ask your fragrance supplier directly which individual components in their blend are known allergens or otherwise require individual naming under current guidance, and at what concentration in the blend.
  3. Multiply those component percentages by your finished product's usage rate of the fragrance blend to get real concentrations, exactly the way you would for any other supplier blend.
  4. Keep the fragrance house's documentation on file, since that is your paper trail if a question comes back to you later.

A worked example

Say your lotion formula uses 0.5% of a fragrance oil blend, and the supplier discloses that one allergen component makes up 3% of that blend. The real concentration of that allergen in your finished lotion is 0.5% times 3%, which works out to 0.015%, or 150 ppm. Whether that crosses a disclosure threshold depends on the specific rule in the market you are filing for and whether the product is leave-on or rinse-off, so check the applicable threshold rather than assuming.

A quick format check before you submit

Check Why it matters
Every ingredient shown by INCI name, not trade name Trade names are not recognized in the listing
Blends expanded into individual components The listing wants real ingredients, not marketing bundles
Percentages reflect component-in-blend math, not blend use level alone A raw use-level percentage overstates or understates the real component concentration
Fragrance handled as a mixture entry plus any individually disclosed components Protects trade secrecy while meeting disclosure duties
Water listed as Aqua Standard INCI convention

Why this groundwork pays off everywhere

Once you have done the work of mapping every raw material to its real INCI name and expanded every blend into honest percentages, that same ingredient data serves any market you expand into next, not just the one you started with. Cosmetic Comply is built around exactly this mapping step. Feed it your formula and ingredient list, and it matches each item to its INCI name and CAS number, expands supplier blends and carries the real percentages through, and flags anything that needs a closer look before it gets anywhere near a submission. Canada is live today, with the US, EU, and Australia on the way, so the ingredient work you do now is not wasted the moment you want to sell somewhere new.

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