Lutein, Vitamin C & Vitamin E

Lutein, vitamin C and vitamin E reference formula at example amounts of 250 mcg, 60 mg and 22.5 mg per serving, developed as a tablet or capsule.

Lutein, Vitamin C & Vitamin E is a reference formula for brands building an eye-nutrition product around three actives: a carotenoid, a water-soluble vitamin and a fat-soluble vitamin. The example serving carries 250 mcg of lutein, 60 mg of vitamin C and 22.5 mg of vitamin E, and the brand sets the final amounts for its market. This page covers the three named actives of the reference formula.

Tablet is the lead format because the three actives fit one compressed unit, and a capsule version carries the same actives in a blended fill. The development work centers on a microgram-level carotenoid next to milligram-level vitamins, the vitamin E form and unit, and color and stability of the finished unit.

Ingredient Composition

IngredientPer ServingRaw Material FormAlternative Form (same amount of active)
Lutein250 mcg (example amount)Marigold flower extract as a free-flowing powder, specified on lutein content, for example the Marigold Extract 10–20% Lutein grade; 250 mcg lutein per servingA higher-assay marigold extract, with the input recalculated to 250 mcg of lutein
Vitamin C60 mg (example amount)L-ascorbic acid, specified on an ascorbic acid basis; 60 mg vitamin C per servingSodium ascorbate, with the input recalculated to 60 mg of ascorbic acid; natural-source Acerola Cherry Extract 17–25% Natural Vitamin C with the input set from its vitamin C content
Vitamin E22.5 mg (example amount)Dry tocopheryl acetate powder, with the form and the label basis set in the specificationNatural-source tocopherol grades, declared on their own basis

Amounts are stated as mcg of lutein (C40H56O2, 568.9 g/mol; PubChem CID 5281243), mg of vitamin C on an ascorbic acid basis (C6H8O6, 176.12 g/mol; CID 54670067) and mg of vitamin E. Reference labels state vitamin E in mg and, for a few, in IU; the conversion depends on the natural or synthetic form, so the IU labels are kept apart and no conversion is applied on this page. Marigold lutein is commonly an ester, and the assay basis, free lutein or ester, is set with the supplier.

Intended Benefits & Formula Rationale

This formula is designed for products positioned around eye nutrition and antioxidant nutrition. Lutein, vitamin C and vitamin E are included together so that one serving carries a carotenoid and two antioxidant vitamins.

Intended Benefit DirectionKey IngredientsFormulation Rationale
Antioxidant vitamin nutrition for the eyeVitamin C, Vitamin EA Cochrane review of 26 trials found that people with age-related macular degeneration taking antioxidant vitamins were less likely to progress to late disease (odds ratio 0.72, moderate-certainty evidence), with most evidence from the AREDS trial [1]. Evidence: Referenced
Lutein in the eye formulationLuteinIn the AREDS2 trial, adding lutein and zeaxanthin to the AREDS formulation did not further reduce progression to advanced macular degeneration, and the authors noted that lutein and zeaxanthin could be an appropriate carotenoid substitute for beta carotene [3]. Evidence: Mixed

The AREDS trial used 500 mg of vitamin C and 400 IU of vitamin E per day with beta carotene and zinc [2], much more than the example amounts here, so amounts, claims and target market are brand decisions reviewed for each sales market.

Available Formats

The lutein, vitamin C and vitamin E reference formula is built for a tablet version and a capsule version; counts per serving are design choices that the brand can adjust.

FormatUnitPer ServingPack SizeOther Ingredients (typical)Suitability
Tablet1 tabletLutein 250 mcg, vitamin C 60 mg, vitamin E 22.5 mg60 or 100 tabletsMicrocrystalline cellulose, maltodextrin, modified corn starch, silicon dioxide, film coatLead format; three actives in one coated unit
Capsule1 capsuleLutein 250 mcg, vitamin C 60 mg, vitamin E 22.5 mg60 or 90 capsulesGelatin or vegetable shell, cellulose, flow agentBlended fill without a compression step

Raw Material Input & Fill (Design Estimate)

Design estimates. The lutein input assumes a 10% marigold extract (the low end of the linked grade), so 250 mcg of lutein needs 2.5 mg of extract; vitamin C is taken at 100% ascorbic acid, 60 mg; and vitamin E is taken as a 50% dry powder, so 22.5 mg needs 45 mg of powder. Together the three raw materials weigh about 107.5 mg per unit.

FormatRaw Material Input per UnitDesign FillBalance for ExcipientsVerification Before Scale-Up
TabletExtract 2.5 mg, ascorbic acid 60 mg, vitamin E powder 45 mg300 mg tablet weight192.5 mgContent uniformity of lutein, hardness, disintegration, color, content assay of the three actives
CapsuleExtract 2.5 mg, ascorbic acid 60 mg, vitamin E powder 45 mg250 mg per capsule142.5 mgBlend uniformity of lutein, fill weight variation, content assay of the three actives

Gummy and softgel versions are separate projects, because vitamin C and carotenoid stability in a gummy matrix and a lutein oil fill each need their own work.

Formulation Considerations

Microgram carotenoid among milligram vitamins. At 2.5 mg of extract against 60 mg of ascorbic acid, the lutein carrier is a small share of the unit. A premix of the marigold extract and a blending order are set first, and content uniformity of lutein across the first units decides whether the premix holds.
Color and light. Marigold extract is orange and sensitive to light and oxygen, and ascorbic acid darkens with moisture. A film coat, an opaque bottle and a desiccant are part of the stability plan.
Vitamin E form and unit. Reference labels state vitamin E in mg and in IU, and the example label lists a synthetic tocopheryl acetate. The form and the label basis go into the specification, and mg and IU option sets are not converted into each other.
Evidence and claims. The trials in [1] to [3] were run in people with age-related macular degeneration at higher amounts, and AREDS2 found no further risk reduction from adding lutein and zeaxanthin [3]. Claims on a finished product are reviewed for each sales market before a product is developed.

Customization Options

Brands adjust the amount of each active, the vitamin E form, the format and the add-ons.

ParameterRangeNote
Lutein per serving250, 300 or 500 mcgExamples for the brand; extract weight scales with the amount
Vitamin C per serving60, 100, 120 or 150 mgExamples for the brand; ascorbic acid dominates the raw material weight
Vitamin E per serving15.8, 22.5, 27 or 67 mgExamples for the brand; form and label basis set in the specification
FormatTablet or capsuleGummy and softgel are separate projects
Add-onsZinc, zeaxanthin, vitamin AA fourth active reshapes the tablet weight and the color and stability plan

The pilot run confirms content uniformity of lutein at microgram level, color and coating behavior of the tablet, capsule fill weight, and the content assay of all three actives in the first units against the labeled amounts.

Technical Status & Data Sources

ItemStatusDetails
Reference formulaNIH DSLDThe ingredient and amount come from a labeled product in the NIH DSLD (lutein 250 mcg, vitamin C 60 mg and vitamin E 22.5 mg on the label of CF014137, a multivitamin and mineral tablet; example DSLD labels 204705, 204722, 204726). The label names the three actives by name; a marigold lutein extract, ascorbic acid and tocopheryl acetate are set as the forms.
SpecificationSet in formulationMarigold extract (lutein content), L-ascorbic acid and vitamin E powder, per serving 250 mcg lutein, 60 mg vitamin C and 22.5 mg vitamin E; assay, form basis, residue 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] Evans JR, Lawrenson JG. Antioxidant vitamin and mineral supplements for slowing the progression of age-related macular degeneration. Cochrane Database Syst Rev. 2023;9(9):CD000254. DOI · PubMed<br>[2] Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001;119(10):1417-36. DOI · PubMed<br>[3] Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013;309(19):2005-15. DOI · PubMed

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