Lutein & Zeaxanthin

Two-carotenoid lutein and zeaxanthin reference formula with 20 mg and 4 mg per serving, developed as a softgel, with a capsule option.

Lutein & Zeaxanthin is a reference formula for brands building a carotenoid pair product with example amounts of 20 mg of lutein and 4 mg of zeaxanthin per serving. The two carotenoids are isomers that share one oil phase, so the development work centers on the marigold-derived raw material and its ratio, keeping both carotenoids stable against light and oxygen, and the softgel or capsule system that carries them.

Softgel is the lead format because both carotenoids are fat-soluble and sit well suspended in oil, with a capsule version for brands that prefer a dry fill. The reference labels hold zeaxanthin from 100 mcg to 10 mg next to lutein, so the ratio of the two is a brand decision set around the 5:1 example.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Lutein20 mg (example amount)Lutein from marigold extract, for example the Marigold Extract 10–20% Lutein grade; specification 20 mg lutein per serving, assay basis and isomer content set with the supplierA higher-assay marigold extract, which needs a smaller input weight for the same 20 mg of lutein
Zeaxanthin4 mg (example amount)Zeaxanthin from the same marigold-derived source or from a separate zeaxanthin ingredient; specification 4 mg zeaxanthin per serving, ratio to lutein set with the supplierA separate zeaxanthin concentrate, which allows a ratio other than 5:1

Amounts are stated as mg of free lutein and free zeaxanthin; both are C40H56O2 with a molecular weight of 568.9 g/mol (lutein, zeaxanthin on PubChem). The extract input equals the labeled amount divided by the assay, so a combined source that carries 20% lutein and 4% zeaxanthin supplies both amounts from 100 mg of extract.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around eye nutrition in adults. The two carotenoids are included together because they are the two carotenoids found in the human macula and the reference labels sell them as a pair.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Macular pigment nutritionLutein, ZeaxanthinA systematic review and meta-analysis of 46 studies with 3,189 participants with healthy eyes found that macular pigment optical density rose with lutein and zeaxanthin intake, with a mean increase of 0.11 units at 20 mg per day or more for 3 to 12 months [1]. Evidence: Referenced
Long-term eye nutritionLutein, ZeaxanthinIn the AREDS2 randomized trial, adding lutein and zeaxanthin to the AREDS formulation did not significantly reduce progression to advanced macular degeneration in the primary analyses (hazard ratio 0.90, 98.7% CI 0.76–1.07) [2]. Evidence: Contested

The amounts in each study were set by the study, and the populations differ, so amount, claims and target market for a finished product are brand decisions reviewed for each sales market.

Available Formats

The reference formula is built for a softgel version and a capsule version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Softgel1 softgel20 mg lutein, 4 mg zeaxanthin30 or 60 softgelsVegetable or medium-chain oil, gelatin or plant-based shell, glycerinLead format; both carotenoids suspended in oil
Capsule1 capsule20 mg lutein, 4 mg zeaxanthin60 or 90 capsulesMicrocrystalline cellulose diluent, anti-caking flow agent, plant-based capsule shellDry fill; powdered extract protected from light and air

Raw Material Input & Fill (Design Estimate)

Design estimates. The input is the labeled carotenoid weight divided by an assumed assay of 20% lutein and 4% zeaxanthin in the combined extract as purchased, so 100 mg of extract carries both amounts; the real input follows the certificate of analysis.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
Softgel100 mg combined extract480 mg fill per softgel380 mg oil and suspending agentSuspension stability, shell compatibility, assay of both carotenoids
Capsule100 mg combined extract270 mg per capsule170 mgFlow, fill weight variation, assay of both carotenoids, color

Gummy, powder and tablet versions are separate projects, because carotenoids need their own protection and dispersion system in those formats.

Formulation Considerations

Ratio and source. The ratio of lutein to zeaxanthin is fixed by the raw material or by a second ingredient. A 5:1 ratio of 20 mg to 4 mg can come from one extract, while other ratios need a separate zeaxanthin source and a second assay.
Two isomers, one assay. Lutein and zeaxanthin are isomers with the same molecular weight, so the assay method has to separate them. The specification names the method and reports each carotenoid on its own.
Light and oxygen. Both carotenoids lose potency in light and air. The fill carries an antioxidant, the units are packed in opaque containers, and stability is checked on the finished unit for each carotenoid.
Evidence and tier. The review in [1] covers adults with healthy eyes and the trial in [2] covers adults with macular degeneration, with different outcomes. The dose limit, the target audience and label wording for each sales market are reviewed before a product is developed.

Customization Options

Brands adjust the lutein amount, the zeaxanthin amount and ratio, the format and the add-ons.

ParameterRangeNote
Lutein per serving10, 20 or 40 mgExamples for the brand; fill weight changes with the amount
Zeaxanthin per serving1 or 4 mgSets the ratio to lutein and the choice of raw material
FormatSoftgel or capsuleGummy, powder and tablet are separate projects
Pack size30 to 90 unitsSet by the brand
Add-onsBilberry, vitamin CBilberry extract is a dry powder that suits the capsule format, and vitamin C needs a separate dry compartment in a softgel

The pilot run confirms suspension stability in the oil, shell compatibility, and the assay of both carotenoids in the first units against the specification.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (Lutein 20 mg + Zeaxanthin 4 mg on the label of CF008363; example DSLD labels 63231, 209399, 269662). The label names the ingredients as lutein and zeaxanthin; marigold extract is set as the raw material.
SpecificationSet in formulationLutein 20 mg and zeaxanthin 4 mg per serving from marigold-derived raw material; assay of each carotenoid, isomer content, residual solvent, pesticide and heavy-metal limits and method are fixed with the supplier. Unit size, fill weight and stability are set in formulation.
Data sourceNIH DSLDDSLD v9.4.0, downloaded 2026-01-10: 50,824 reference formulas merged from on-market labels with complete ingredient amounts. Counts show how labels are distributed.
Market reviewPer marketDose limits, labeling and claims are reviewed for each sales market before a finished product is developed.
ReferencesSources[1] Wilson LM, Tharmarajah S, Jia Y, Semba RD, Schaumberg DA, Robinson KA. The effect of lutein/zeaxanthin intake on human macular pigment optical density: a systematic review and meta-analysis. Adv Nutr. 2021;12(6):2244-2254. DOI · PubMed<br>[2] Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the AREDS2 randomized clinical trial. JAMA. 2013;309(19):2005-2015. DOI · PubMed

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