Is Minoxidil safe in cosmetics?
Minoxidil has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: restricted.
Moderate
Active Ingredient
Minoxidil
Also known as: 2,4-Pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide, Pyrimidine, 2,4-diamino-6-piperidino-, 3-oxide, 2,6-Diamino-4-(piperidin-1-yl)pyrimidin-1-ium-1-olate, 5-25-12-00317, BRN 0886240 (+13 more)
INCI: MINOXIDIL
Minoxidil (CAS 38304-91-5) is a cosmetic active ingredient functioning as vasodilator; hair-growth stimulant; potassium-channel opener. 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 38304-91-5 →
Auto-generated CPSR Part A draft with source citations
Function
vasodilator; hair-growth stimulant; potassium-channel opener
Safety Rating
MODERATE
Regulatory Status
EU EU Status
prohibited
US US Status
restricted
US Notes
FDA-approved OTC drug for androgenetic alopecia: 2% approved for women (1991), 5% approved for men (1988). Not a cosmetic ingredient in the US — classified as an OTC drug under monograph system. Adverse effects include allergic contact dermatitis.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Minoxidil.
Calculate MoS for your specific formulation with the MoS Calculator.
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 372
(EC) 2009/1223
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (7)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| IN | banned | - | all cosmetics — classified as drug in India |
| IN | drug_classification | - | anti-hair loss products claiming treatment effect |
| AU | therapeutic_good | - | hair growth |
| BR | banned | - | Pharmaceutical drug; prohibited as cosmetic ingredient |
| CA | banned | - | - |
| CA | drug_classification | - | - |
| KR | prohibited | - | - |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Hair Loss Treatment | 2–5 | 5 | FDA OTC |
Additional Ingredient Properties
3 property records from structured ingredient metadata.
hair_conditioning
{"cas_number": "38304-91-5", "ingredient_class": "hair_growth", "chemical_type": "other", "substantivity_to_hair": "poor", "deposition_from_shampoo": "no", "deposition_from_conditioner": "yes", "conditioning_mechanism": "vasodilation_follicle_activation", "hair_penetration": "scalp_follicle_deep", "molecular_weight_effect_on_penetration": "low_MW_penetrates_deeply", "cuticle_smoothing": "no", "18_…
pregnancy_detail
{"pregnancy_safe": "no", "breastfeeding_safe": "no", "trimester_restriction": "all", "risk_category": "FDA-C", "reason": "Vasodilator; potential fetal cardiovascular effects", "alternative_ingredient": "Rosemary extract (topical, post-pregnancy)", "source": "FDA; dermatology literature"}
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "yes", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv":…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Hair fixative
Softener and conditioner
Regulatory List Membership (2)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Minoxidil.
Regulatory Flags
prohibited-eu
drug-not-cosmetic
annex-ii
otc-drug-us
contact-dermatitis-risk
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
2,4-Pyrimidinediamine, 6-(1-piperidinyl)-, 3-oxide
Pyrimidine, 2,4-diamino-6-piperidino-, 3-oxide
2,6-Diamino-4-(piperidin-1-yl)pyrimidin-1-ium-1-olate
5-25-12-00317
BRN 0886240
2,3-Dihydro-3-hydroxy-2-imino-6-(1-piperidinyl)-4-pyrimidinamine
EINECS 253-874-2
6-Piperidino-2,4-diaminopyrimidine 3-oxide
6-(1-Piperidinyl)-2,4-pyrimidinediamine 3-oxide
Regaine
2,6-Diamino-4-piperidinopyrimidin-1-oxid
Theroxidil
Men's Rogaine
Minodyl
2,4-Diamino-6-piperidinilpirimidina-3-ossido
Minossidile
Minoxidilum
UNII-5965120SH1
Chemical Function
Softener and conditioner
Hair fixative
Regulatory Lists
banned; Europe; Personal care
pharmaceutical
Canada; pharmaceutical
Canada; 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
MINOXIDIL
ChEMBL ID
CHEMBL802
Max Phase
4
Adverse Event Associations
1252
Frequently Asked Questions
Is Minoxidil allowed in the EU?
Minoxidil EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Minoxidil do in cosmetics?
Minoxidil functions as: vasodilator; hair-growth stimulant; potassium-channel opener. It is classified as a Active Ingredient in our database. CAS number: 38304-91-5.
Is Minoxidil used outside cosmetics?
Minoxidil also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Minoxidil compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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