CHOLECALCIFEROL

CHOLECALCIFEROL (CAS 67-97-0) is a cosmetic active ingredient functioning as Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes;. EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.

View industrial chemical safety profile for CAS 67-97-0 →

Auto-generated CPSR Part A draft with source citations
Function
Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes; keratinocyte differentiation regulator; barrier support; immune modulator
Safety Rating
POOR

Regulatory Status

EU EU Status prohibited
US US Status restricted
US Notes Not categorically prohibited in US cosmetics. Referenced in FDA OTC Monograph M016 (Skin Protectant Drug Products) at 400 USP Units cholecalciferol combined with Vitamin A 10,000 USP Units in permitted combination products. Not listed as an approved sunscreen active under OTC Monograph M020. When intended for therapeutic purposes classified as a drug under the FD&C Act; as nutritional supplement regulated under DSHEA. Any cosmetic product making claims related to vitamin D's physiological functions would likely be regulated as a drug or drug-cosmetic combination.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for CHOLECALCIFEROL.

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Expert safety assessment and concern-level summary for CHOLECALCIFEROL.

Regulatory Flags

eu-prohibited annex-ii no-sccs-opinion no-cir-review pharmaceutical-api fda_food_additive

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
CHOLECALCIFEROL
ChEMBL ID
CHEMBL1042
Max Phase
4
Adverse Event Associations
17331
View full pharmaceutical profile →

Frequently Asked Questions

Is CHOLECALCIFEROL safe in cosmetics?

CHOLECALCIFEROL has a safety rating of "POOR" in our database. EU status: prohibited. US status: restricted.

Is CHOLECALCIFEROL allowed in the EU?

CHOLECALCIFEROL EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does CHOLECALCIFEROL do in cosmetics?

CHOLECALCIFEROL functions as: Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes; keratinocyte differentiation regulator; barrier support; immune modulator. It is classified as a Active Ingredient in our database. CAS number: 67-97-0.

Is CHOLECALCIFEROL used outside cosmetics?

CHOLECALCIFEROL also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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