# POLYSORBATE 80

URL: https://app.greenveil.ai/ingredients/ingredient_dtxsid_dtxsid0021175
Categories: beauty, cleaning, food, industrial, pharma
Functions: Anti-static agent, Cleaning agent, Dispersing agent, Emulsifier, Flavouring and nutrient, Fragrance, Lubricating agent, Pharmaceutical, Solvent, Surfactant (surface active agent), Wetting agent (non-aqueous), anti-fogging agents
Identifier: DTXSID0021175

> POLYSORBATE 80 is used as anti-static agent / cleaning agent. EPA CPDat observed this chemical in 1566 composition records across product categories including Food and drug, Pesticides, Raw materials. Assessed from 88 sources.

## Safety assessment

- Chemical concern: not yet assessed
- Rationale: EPA CPDat observed this chemical in 1566 composition records across product categories including Food and drug, Pesticides, Raw materials.

## Regulatory status

- US: commercial use observed — EPA CPDat observed this chemical in 1566 composition records across product categories including Food and drug, Pesticides, Raw materials. EPA CPDat classifies this chemical for functional uses including Emulsifier, Fragrance, Surfactant (surface active agent).
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: DROPS; Potency: 0.02 %w/w
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: SOLUTION; Potency: 0.2 %w/w
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: SOLUTION/ DROPS; Maximum daily exposure: 13 mg
- US: inactive ingredient database — Route: AURICULAR (OTIC); Dosage form: SUSPENSION; Potency: 1 %w/v
- US: inactive ingredient database — Route: INTRA-ARTICULAR; Dosage form: INJECTION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRA-ARTICULAR; Dosage form: INJECTION, POWDER, FOR SUSPENSION; Maximum daily exposure: 5 mg
- US: inactive ingredient database — Route: INTRA-ARTICULAR; Dosage form: INJECTION, SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRALESIONAL; Dosage form: INJECTION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRALESIONAL; Dosage form: INJECTION, SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION; Potency: 4 %w/v
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, POWDER, FOR SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, SOLUTION; Potency: 5 %w/v
- US: inactive ingredient database — Route: INTRAMUSCULAR; Dosage form: INJECTION, SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRASYNOVIAL; Dosage form: INJECTION; Potency: 0.2 %w/v
- US: inactive ingredient database — Route: INTRASYNOVIAL; Dosage form: INJECTION, SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: CONCENTRATE; Maximum daily exposure: 4680 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION; Maximum daily exposure: 4680 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, FOR SOLUTION; Potency: 53 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION; Maximum daily exposure: 900 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION; Maximum daily exposure: 1170 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SOLUTION, CONCENTRATE; Maximum daily exposure: 4739 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: INJECTION, SUSPENSION; Potency: 0.5 %w/v
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: LIQUID; Maximum daily exposure: 720 mg
- US: inactive ingredient database — Route: INTRAVENOUS; Dosage form: SOLUTION; Maximum daily exposure: 900 mg
- US: inactive ingredient database — Route: INTRAVITREAL; Dosage form: INJECTION, SUSPENSION; Potency: 0.02 %w/v
- US: inactive ingredient database — Route: NASAL; Dosage form: SPRAY; Potency: 0.01 mg
- US: inactive ingredient database — Route: NASAL; Dosage form: SPRAY, METERED; Potency: 0.1 mg/1ml
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: DROPS; Potency: 0.05 %w/w
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: EMULSION; Maximum daily exposure: 26 mg
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SOLUTION; Maximum daily exposure: 8 mg
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SOLUTION, GEL FORMING, EXTENDED RELEASE; Potency: 0.05 %w/w
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SOLUTION/ DROPS; Potency: 0.25 %w/v
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SUSPENSION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: OPHTHALMIC; Dosage form: SUSPENSION/ DROPS; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE; Potency: 418.37 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED; Potency: 0.04 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, COATED PELLETS; Potency: 2 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, DELAYED RELEASE; Maximum daily exposure: 23 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, EXTENDED RELEASE; Maximum daily exposure: 10 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CAPSULE, LIQUID FILLED; Maximum daily exposure: 24 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: CONCENTRATE; Potency: 1 mg/1ml
- US: inactive ingredient database — Route: ORAL; Dosage form: ELIXIR; Potency: 2.5 mg/15ml
- US: inactive ingredient database — Route: ORAL; Dosage form: GRANULE, FOR SUSPENSION; Maximum daily exposure: 240 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: PASTE; Maximum daily exposure: 28 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER; Potency: 66 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: POWDER, FOR SUSPENSION; Maximum daily exposure: 150 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SOLUTION; Maximum daily exposure: 907 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION; Maximum daily exposure: 206 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION, EXTENDED RELEASE; Maximum daily exposure: 40 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: SUSPENSION/ DROPS; Maximum daily exposure: 23 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET; Maximum daily exposure: 233 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, CHEWABLE; Maximum daily exposure: 84 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, COATED; Maximum daily exposure: 18 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, DELAYED RELEASE; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, EXTENDED RELEASE; Maximum daily exposure: 10 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED; Potency: 24 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, FILM COATED, EXTENDED RELEASE; Potency: 8 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: ORAL; Dosage form: TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE; Maximum daily exposure: 34 mg
- US: inactive ingredient database — Route: RECTAL; Dosage form: ENEMA; Potency: 0.01 %w/v
- US: inactive ingredient database — Route: RECTAL; Dosage form: SOLUTION; Maximum daily exposure: 315 mg
- US: inactive ingredient database — Route: RECTAL; Dosage form: SUPPOSITORY; Potency: 72.15 mg
- US: inactive ingredient database — Route: RESPIRATORY (INHALATION); Dosage form: SUSPENSION; Maximum daily exposure: 1 mg
- US: inactive ingredient database — Route: SOFT TISSUE; Dosage form: INJECTION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: SOFT TISSUE; Dosage form: INJECTION, SUSPENSION; Maximum daily exposure: 4 mg
- US: inactive ingredient database — Route: SUBCUTANEOUS; Dosage form: INJECTION, SUSPENSION; Potency: 0.3 %w/v
- US: inactive ingredient database — Route: SUBCUTANEOUS; Dosage form: SUSPENSION; Potency: 0.3 %w/v
- US: inactive ingredient database — Route: SUBLINGUAL; Dosage form: TABLET; Potency: 0.08 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: AEROSOL, FOAM; Potency: 0.98 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: CREAM; Maximum daily exposure: 20 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: EMULSION; Potency: 2.5 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: GEL; Maximum daily exposure: 12 mg
- US: inactive ingredient database — Route: TOPICAL; Dosage form: LOTION; Potency: 15 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: OINTMENT; Potency: 0.1 %w/w
- US: inactive ingredient database — Route: TOPICAL; Dosage form: SYSTEM; Maximum daily exposure: 28 mg
- US: inactive ingredient database — Route: VAGINAL; Dosage form: AEROSOL, FOAM; Potency: 3 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: CREAM; Potency: 0.4 %w/w
- US: inactive ingredient database — Route: VAGINAL; Dosage form: SUPPOSITORY; Potency: 28 mg
- US: marketed drug occurrence — FDA NDC lists this ingredient in 14 active drug products and 14 total products.
- US: listed in openFDA substance — openFDA substance registry classifies this ingredient as polymer.

_Assessed by Greenveil._