Indocyanine Green

INCI: INDOCYANINE GREEN

CAS Number
3599-32-4 / EC 222-751-5
Function
Colorant, diagnostic dye
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes FDA-approved as injectable diagnostic drug (21 CFR) but not listed as permitted color additive for cosmetics under 21 CFR Parts 73, 74, or 82

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
low
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Pharmaceutical-grade ingredient with reproductive toxicity risk and anaphylactoid reactions reported; contains sodium iodide, contraindicated for iodine-sensitive individuals; not appropriate for cosmetic formulation.

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Concern Level: High

Regulatory Flags

colorant

Frequently Asked Questions

Is Indocyanine Green safe in cosmetics?

Pharmaceutical-grade ingredient with reproductive toxicity risk and anaphylactoid reactions reported; contains sodium iodide, contraindicated for iodine-sensitive individuals; not appropriate for cosmetic formulation. The EU classifies Indocyanine Green as "permitted". Safety rating: POOR.

Is Indocyanine Green allowed in the EU?

Indocyanine Green EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Indocyanine Green do in cosmetics?

Indocyanine Green functions as: Colorant, diagnostic dye. It is classified as a cosmetic ingredient in our database. CAS number: 3599-32-4 / EC 222-751-5.

What is the Margin of Safety for Indocyanine Green?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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