Is Ursodiol safe in cosmetics?
Ursodiol has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Cosmetic Ingredient
Ursodiol
Also known as: Ursodesoxycholic acid, Ursocholic acid, deoxy-, Cholan-24-oic acid, 3,7-dihydroxy-, (3α,5β,7β)-, (3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid, 4-10-00-01604 (+13 more)
INCI: URSODIOL
Ursodiol (CAS 128-13-2) is a cosmetic cosmetic ingredient functioning as Skin conditioning, skin protecting. EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 128-13-2 →
Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning, skin protecting
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
(4R)-4-[(3R,5S,7S,8R,9S,10S,13R,14S,17R)-3,7-dihydroxy-10,13-dimethyl-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1H-cyclopenta[a]phenanthren-17-yl]pentanoic acid
InChIKey
RUDATBOHQWOJDD-UZVSRGJWSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted for cosmetic use (note: also an FDA-approved pharmaceutical — ursodeoxycholic acid — for gallstone dissolution, but cosmetic use is separate and permitted)
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ursodiol.
Calculate MoS for your specific formulation with the MoS Calculator.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Humectant
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Ursodiol.
Known Synonyms
Ursodesoxycholic acid
Ursocholic acid, deoxy-
Cholan-24-oic acid, 3,7-dihydroxy-, (3α,5β,7β)-
(3α,5β,7β)-3,7-Dihydroxycholan-24-oic acid
4-10-00-01604
BRN 3219888
3-alpha,7-beta-Dihydroxy-5-beta-cholanoic acid
EINECS 204-879-3
7-beta-Hydroxylithocholic acid
17-beta-(1-Methyl-3-carboxypropyl)etiocholane-3-alpha,7-beta-diol
Peptarom
Urso DS
Urso Forte
NSC 657950
Acido ursodeossicolico
Acidum ursodeoxycholicum
UNII-724L30Y2QR
(3a,5b,7b)-3,7-dihydroxy-cholan-24-oate
Chemical Function
Humectant
Softener and conditioner
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
pharmaceutical
pharmaceutical
pharmaceutical
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
URSODIOL
ChEMBL ID
CHEMBL1551
Max Phase
4
Adverse Event Associations
3285
Frequently Asked Questions
Is Ursodiol allowed in the EU?
Ursodiol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Ursodiol do in cosmetics?
Ursodiol functions as: Skin conditioning, skin protecting. It is classified as a cosmetic ingredient in our database. CAS number: 128-13-2.
Is Ursodiol used outside cosmetics?
Ursodiol also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Ursodiol compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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