What does polysorbate 80 do in eye drops?

In an over-the-counter eye drop, polysorbate 80 is a lubricant. FDA’s rules for nonprescription eye drops, 21 CFR 349.12, list it among the ophthalmic demulcents, ingredients that coat and lubricate the eye’s surface. Quell lists it as an active ingredient, Polysorbate 80 (1.0%), with the purpose “lubricant.” Chemically it’s also an emulsifier, which helps oil and water mix, and that suits a formula that blends both.

Why is polysorbate 80 used in eye drops?

There are two answers, one from the label and one from chemistry. On the label, polysorbate 80 has a single stated job: lubricant. That’s the role the Drug Facts panel assigns it, and it’s the role that counts legally. In chemistry, polysorbate 80 belongs to a family of compounds called surfactants, which have one end that’s attracted to water and another that’s attracted to oil. That structure lets them sit between oil and water and hold the two together.

Quell is an oil-and-water formula. Its actives are Glycerol (1.0%), Polysorbate 80 (1.0%) and Light Mineral Oil (0.5%), and the inactive list includes emu oil and other lipids. The tear film it’s designed to support also has an oily layer over a watery one. Quell is designed to reinforce the tear film’s oil layer to help reduce moisture loss, and an ingredient that’s comfortable on both sides of an oil-water boundary fits that design. The label itself doesn’t explain why each ingredient was chosen, so read the chemistry as background rather than a stated purpose.

What “active ingredient” and “purpose” mean

FDA’s labeling regulation for over-the-counter drugs, 21 CFR 201.66, defines an active ingredient as a component intended to furnish pharmacological activity or another direct effect in the body. Everything else is an inactive ingredient. On the Drug Facts panel, each active is listed with its strength and its purpose, a short word or phrase describing what it does.

For polysorbate 80 in Quell, the purpose is “lubricant,” the same as Glycerol (1.0%). The third active, Light Mineral Oil (0.5%), has the purpose “emollient.” Seeing polysorbate 80 listed as an active, with a strength and a purpose, tells you it’s one of the ingredients the product’s Uses depend on. Those Uses read: For use as a protectant against further irritation or to relieve dryness of the eye. The active ingredients section covers how that part of the panel is laid out.

Polysorbate 80 in FDA’s eye drop rules

Over-the-counter lubricating eye drops follow a set of FDA rules in 21 CFR part 349, often called the ophthalmic monograph. Section 349.12 lists the demulcents a product can use, each “within the established concentrations” for that ingredient. Polysorbate 80 appears there in the group of liquid polyols, alongside glycerin, propylene glycol and two polyethylene glycols. Quell’s label strength, Polysorbate 80 (1.0%), is within the range the regulation sets for it.

That listing is what lets a drop use polysorbate 80 as an active lubricant without a prescription. It’s a regulatory permission, not a statement about how any one person will respond. What is a demulcent in eye drops? walks through the whole list and how demulcents differ from emollients.

Where else polysorbate 80 shows up

Polysorbate 80 isn’t unique to eye drops. FDA’s food additive regulations, at 21 CFR 172.840, describe it as a compound made by reacting oleic acid with sorbitol and then with ethylene oxide, and permit it as an emulsifier in ice cream and other frozen desserts, among other uses. It also appears in cosmetics and many medicines. Its chemical name, polyoxyethylene (20) sorbitan monooleate, is the one you may see on technical documents.

Familiarity in food doesn’t tell you how it will feel in your eye; the eye and the stomach are different places. It does explain why the name turns up on so many ingredient lists.

Polysorbate 80 eye drops: side effects and the label

People often search for side effects of polysorbate 80 in eye drops, or whether it’s okay to use. The Drug Facts panel is the place that answers those questions for a specific product, through its warnings rather than a promise. For Quell, those are:

• The caution: Caution should be used in those with egg or bird allergies — For use in the eyes only.
• Do not use: If this product changes color.
• When using: Do not touch tip of bottle to any surface to avoid contamination.
• Stop use and ask a doctor: Stop use and ask a doctor if you feel eye pain or changes in your vision, if irritation or redness continues, or if the condition worsens or persists for 72 hours.
• If swallowed: If swallowed, get medical help or contact a Poison Control Center immediately.

If you’ve reacted to a product containing polysorbates before, whether a cream, a medicine or another eye drop, tell your doctor or pharmacist before using any drop that lists polysorbate 80. They can look at your history and the full ingredient list together. That’s more useful than a general answer, because reactions are personal.

Polysorbate 80 in Quell, at a glance

• Listed as: Polysorbate 80 (1.0%).
• Purpose on the label: lubricant.
• Listed in FDA’s ophthalmic demulcents at 21 CFR 349.12, within a set concentration range.
• Works alongside Glycerol (1.0%) (lubricant) and Light Mineral Oil (0.5%) (emollient).
• Part of a preservative-free, milky formula; the label notes it Product appears as a milky brown solution.

The complete panel, with all actives, inactives and warnings, is on the Drug Facts page.