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The FDA requires batch-to-batch certification for this ingredient that is held to a pretty rigorous standard. That means the CI 17200 in your cosmetics has been tested and approved before it ever reaches you.

Contact allergy to cosmetic-grade dyes used at low concentrations are uncommon but has been documented before.

This ingredient also goes by the name D&C RED NO. 33.

CI 17200 has a comedogenic rating of 1 and an irritancy rating of 2 on a scale of 0-5. This is based on peer-reviewed research from the man who invented the comedogenic scale.

A 1 on the comedogenic scale is about as low as it gets without being a flat zero, and makes sense for CI 17200.

It's a water-soluble dye used at very small concentrations (typically 0.001-0.1%), so it dissolves into the water phase of a formula rather than sitting on your skin the way an oil or wax would.

The irritancy rating of 2 reflects that, like most synthetic dyes, there's a small possibility of mild irritation ( particularly for people with existing dye sensitivities).

For the vast majority of people, it's a non-issue at typical use levels.

It's also worth keeping in mind that comedogenic and irritancy ratings are tested on individual ingredients, not finished formulas. The final product's formulation, concentration, and other ingredients all play a role in how something actually behaves on your skin.

Just so you know, the FDA ban on Red Dye No. 3 refers to CI 45430, not this ingredient. CI 45430 and CI 17200 are different chemical compounds with distinct safety and regulatory histories.

It's also worth noting that Red No. 3 (CI 45430) was already banned from cosmetics back in 1990, so the 2025 action just extended the ban to food and oral drugs. CI 17200 was never part of any of this.

Some people may experience allergies from this dye, especially asthmatics and those with an aspirin intolerance.

On top of that, this ingredient can counteract the effects of hard water by binding to the minerals in it.

One thing worth knowing is that Disodium EDTA has been shown to be a mild penetration enhancer. It can help other ingredients absorb into skin more effectively which can be a double-edged sword (great for actives, but can also make the active too strong if you have sensitive skin).

Clinical patch testing showed no significant skin irritation at typical use concentrations and minimal dermal absorption.

You'll most likely see this ingredient near the end of an ingredient list. It's typically found in concentrations less than 1%.