# FLUORESCEIN SODIUM

URL: https://app.greenveil.ai/ingredients/ingredient_source_ref_annex_ref_ii_1332
Categories: beauty, cleaning, industrial, pharma
Functions: colorant, Dye
Identifier: 518-45-6

> FLUORESCEIN SODIUM is used as colorant / dye. Greenveil chemical-concern score: 100/100 — Critical concern based on regulatory listings.. Assessed from 9 sources.

## Safety assessment

- Chemical concern score: 100/100 — Critical concern based on regulatory listings.
- Confidence: 4
- Rationale: 2-(6-Hydroxy-3-oxo-(3H)xanthen-9-yl)benzoic acid; Fluorescein and its disodium salt (Acid Yellow 73 sodium salt; CI 45350), when used as a substance in hair dye products is prohibited in cosmetic products under Annex II of the EU Cosmetics Regulation (EC) 1223/2009.

## Regulatory status

- EU: banned — Annex II of EU Cosmetics Regulation (EC) 1223/2009: substances prohibited in cosmetic products.
- EU: allowed_listed — Annex IV of EU Cosmetics Regulation (EC) 1223/2009: colorants allowed in cosmetic products. Other conditions: 6%
- US: commercial use observed — EPA CPDat observed this chemical in 83 composition records across product categories including Raw materials, Laboratory supplies, Personal care. EPA CPDat classifies this chemical for functional uses including Dye.
- US: marketed drug occurrence — FDA NDC lists this ingredient in 12 active drug products and 12 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as chemical.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as concept.

_Assessed by Greenveil._