Piroctone olamine is widely evaluated for scalp-care shampoos, rinse-off treatments, deodorizing products, and antimicrobial cosmetic concepts. For purchasing and formulation teams, however, selecting this ingredient requires more than checking an INCI name and a price. Solubility, use level, claim language, regional regulation, surfactant compatibility, preservation strategy, stability, and supplier documentation all affect whether a laboratory sample can become a compliant commercial product.
This guide gives skincare and hair-care brands a practical framework for sourcing and formulating with Piroctone Olamine. It separates ZLEY supplier data from published finished-formula research and from market-specific regulatory requirements. That distinction is essential: evidence for one shampoo does not automatically validate another formula, and an ingredient permitted in a cosmetic does not automatically support an OTC drug claim.
Quick Answer for Buyers
ZLEY® BIOCARE-OCT has the INCI name Piroctone Olamine. ZLEY supplies it as a white crystalline powder that is soluble in alcohol, with a recommended use range of 0.01%-0.5%. In a shampoo project, a practical laboratory screen may compare a control with several concentrations inside that range, but the final level must be justified by efficacy, safety, stability, regulatory status, claims, and cost-in-use.
Before ordering, identify the target markets and intended claims. In the European Union, Piroctone Olamine is listed in Annex V of the Cosmetics Regulation with maximum concentrations of 1.0% in rinse-off products and 0.5% in other products when used as a preservative. In the United States, it is not among the active ingredients listed in FDA OTC Monograph M032 for control of dandruff, seborrheic dermatitis, or psoriasis. U.S. claim strategy therefore requires specific regulatory review.
ZLEY® BIOCARE-OCT Product Facts
| Item | ZLEY supplier information | Buyer action |
|---|---|---|
| INCI | Piroctone Olamine | Match the INCI across the specification, COA, SDS, safety assessment, and finished-product label. |
| Appearance | White crystalline powder | Set an incoming appearance standard and investigate color or physical-form changes. |
| Solubility | Soluble in alcohol | Develop and document a suitable premix rather than assuming direct water-phase dissolution. |
| Recommended dosage | 0.01%-0.5% | Use the range for laboratory screening; determine the commercial level through formula-specific validation. |
| Supplier positioning | Antimicrobial, deodorizing, scalp-care, and preservative-support applications | Review each intended claim and do not treat supplier positioning as automatic finished-product substantiation. |
See the current ZLEY® BIOCARE-OCT product page and request controlled technical documents before approving a purchase order. Website specifications are useful for screening, while the signed specification and lot-specific COA should control release.
What Published Shampoo Studies Actually Tested
Published research can help a formulator design a prototype, but it must be read at the formula level. Several studies used Piroctone Olamine with different surfactant systems, co-actives, wash frequency, contact time, and test populations.
0.75% Piroctone Olamine plus 2% Salicylic Acid
A double-blind, randomized bilateral study involving 19 subjects compared a shampoo containing 0.75% Piroctone Olamine plus 2% Salicylic Acid with a shampoo containing 1% zinc pyrithione. Subjects used the products twice weekly for almost four weeks. Both shampoos reduced dandruff, and the Piroctone Olamine/Salicylic Acid combination appeared slightly more effective for severity and affected area.
This study does not isolate Piroctone Olamine from Salicylic Acid and its 0.75% concentration is above the ZLEY supplier-recommended maximum of 0.5%. It is evidence for the tested finished formula, not a recommended ZLEY use level.
0.5% Piroctone Olamine in a Sulfate-Free Shampoo
A clinical evaluation in 41 subjects tested a sulfate-free shampoo containing 0.5% Piroctone Olamine. The authors reported anti-dandruff efficacy, reduced density of Malassezia species, and good remanence after use. This concentration sits at the upper end of ZLEY’s stated recommended range.
Scalp Microbiome Study in 100 Participants
A study of 100 dandruff sufferers characterized scalp microbiome changes after three weeks of treatment with either a control shampoo or a shampoo containing 0.5% Piroctone Olamine. The reported microbiome changes were consistent with improved clinical signs and adherent scalp flaking scores versus the control.
Together, these studies support a development rationale, but they do not guarantee identical performance in another surfactant system. The brand should substantiate its own finished product, instructions, claims, and target population.
Regulatory Decision: Define the Market Before the Formula
| Market or document | Key point for buyers | Development implication |
|---|---|---|
| ZLEY supplier recommendation | 0.01%-0.5% | Use as the technical screening range for this specific grade. |
| European Union Cosmetics Regulation, Annex V | For preservative use: maximum 1.0% in rinse-off products and 0.5% in other products | Confirm intended function, product type, safety assessment, and the current consolidated regulation before launch. |
| U.S. FDA OTC Monograph M032 | Piroctone Olamine is not listed among the monograph active ingredients for dandruff control | A U.S. product cannot rely on M032 based on Piroctone Olamine alone. Obtain regulatory advice before making treatment or control claims. |
| Other markets | Limits and product classifications differ | Create a market matrix covering ingredient status, concentration, claims, labeling, notification, and responsible-party requirements. |
The current consolidated EU Cosmetics Regulation lists Piroctone Olamine in Annex V. The FDA M032 monograph page provides the U.S. conditions and permitted active ingredients for OTC dandruff, seborrheic dermatitis, and psoriasis products.
Words such as “treats dandruff,” “controls seborrheic dermatitis,” or “antifungal treatment” can change product classification. Cosmetic wording such as “helps keep the scalp clean,” “supports a balanced scalp environment,” or “helps reduce the appearance of visible flakes” still requires substantiation and market-specific claim review.
How to Build the Premix
ZLEY identifies Piroctone Olamine as alcohol soluble. A formulator should therefore begin with a controlled solvent screen rather than adding the powder directly to the finished shampoo. Record the solvent or carrier, active-to-solvent ratio, temperature, mixing time, order of addition, clarity, and time to complete dissolution.
- Confirm the approved solvent system with the current TDS and supplier technical team.
- Prepare a small premix and verify that no crystals remain before addition.
- Add the premix at a documented stage where it remains compatible with the surfactant and thickener system.
- Check the formula immediately and after 24-48 hours because viscosity and clarity may continue to change.
- Repeat the process at pilot scale; mixing energy and addition rate often differ from laboratory conditions.
If the product must be alcohol-free, do not assume the same process will work. Ask the supplier about alternative solubilization approaches and verify the active remains available, homogeneous, and stable in the selected system.
Prototype Screening Plan
The table below is an example development ladder inside the ZLEY recommendation. It is not a regulatory standard or a universal efficacy recommendation.
| Prototype | Purpose | Questions to answer |
|---|---|---|
| 0% control | Establishes base performance | How much flake reduction, sensory performance, and microbial control comes from the chassis alone? |
| 0.1% | Low-level compatibility screen | Does the active dissolve, remain clear, and avoid destabilizing viscosity? |
| 0.3% | Mid-level performance and cost screen | Is there a meaningful improvement over control without unnecessary formula cost? |
| 0.5% | Upper end of ZLEY’s recommended range and evidence-aligned benchmark | Can the formula remain stable, pleasant, safe, compliant, and support the intended claim? |
Keep all other variables constant when comparing levels. Changing fragrance, surfactant ratio, thickener, preservative, and active level at the same time makes the result difficult to interpret.
Surfactant, Viscosity, and Sensory Checks
A successful scalp shampoo must deposit and rinse appropriately while remaining pleasant enough for repeat use. Screen the active in the complete surfactant system, including amphoteric, anionic, nonionic, and cationic components where relevant.
- Clarity: check haze, crystals, sediment, and color under controlled lighting.
- Viscosity: measure after manufacture, after 24-48 hours, and during stability; do not rely only on the first reading.
- Foam and rinse: compare foam volume, foam quality, rinse feel, and residue against the control.
- Conditioning: assess wet combing and hair feel because scalp efficacy does not compensate for poor consumer experience.
- Fragrance and odor: confirm that the active and solvent system do not change the intended profile.
- Packaging: verify pump or cap function, leakage, paneling, stress cracking, and formula discoloration.
For related scalp-care concepts, ZLEY also supplies Climbazole and the oil-control active Capryloyl Glycine. Combining actives changes the regulatory, safety, solubility, and evidence assessment; evaluate the complete system rather than adding ingredients only to strengthen the label story.
Do Not Assume It Replaces the Preservative System
ZLEY positions Piroctone Olamine for antimicrobial and preservative-support applications. That does not mean every formula will pass preservation testing with Piroctone Olamine as the only control measure. Shampoo contamination risk depends on water activity, raw materials, manufacturing hygiene, packaging, consumer use, pH, and the full antimicrobial system.
Run a documented microbiological risk assessment and preservative efficacy test on the finished formula in the final package. Test the formula after relevant stability exposure, not only immediately after manufacture. If the active level is chosen for scalp-care performance rather than preservation, clearly document both functions and the evidence supporting each.
Example Stability and Validation Matrix
| Test | What to monitor | Why purchasing should care |
|---|---|---|
| Room-temperature control | Appearance, odor, pH, viscosity, active assay if available, and package function | Provides the comparison baseline for every accelerated condition. |
| Elevated temperature | Color, odor, crystallization, separation, pH drift, and viscosity | Reveals formula or packaging risk before scale-up. |
| Low temperature | Crystals, haze, pumpability, and recovery after returning to room temperature | Important for winter transport and cold-market distribution. |
| Freeze-thaw where relevant | Separation, sediment, viscosity recovery, and package integrity | Helps define shipping controls and distribution risk. |
| Preservative efficacy | Microbial reduction and recovery under the selected method | Confirms the complete protection system rather than relying on an ingredient assumption. |
| Consumer-use simulation | Dispensing, water ingress, residue, cap contamination, and dose consistency | Connects laboratory stability to actual use conditions. |
Define acceptance criteria before starting the study. “No obvious change” is not an adequate release standard. Set limits for pH, viscosity, appearance, odor, mass loss, microbiological quality, and packaging performance.
Supplier Documents to Request
- Current TDS with INCI, appearance, solubility, recommended use level, processing, storage, and shelf life.
- SDS covering handling, transport, exposure controls, and emergency information.
- Signed specification with identity, assay, appearance, moisture, impurity, and microbiological limits where applicable.
- Lot-specific COA tied to the approved specification and identifiable test methods.
- Country of origin, manufacturer identity, batch traceability, and change-notification policy.
- Residual solvent, heavy metal, allergen, GMO, animal-origin, and other statements required by the target markets.
- Quality-system, complaint, deviation, and recall contacts.
- Market-specific support documents requested by the safety assessor or responsible person.
Approve the signed specification before the commercial order. A COA reports one batch; it does not replace the agreement that defines acceptable future batches.
Incoming Quality Control
Procurement, quality, and R&D should agree on incoming checks before the first shipment. Verify container integrity, label, lot number, quantity, appearance, and every COA result against the approved specification. Depending on risk, periodically verify identity, assay, moisture, relevant impurities, and microbiological quality through an internal or qualified external laboratory.
Retain samples from the development lot and commercial lots. If a later batch changes shampoo color, clarity, odor, viscosity, or performance, retained samples provide a common comparison for the manufacturer and supplier.
RFQ Checklist for Piroctone Olamine
- Product format: clear shampoo, opaque shampoo, scalp serum, rinse-off treatment, deodorant, or another format.
- Target concentration and intended ingredient function.
- Target countries and exact proposed claim language.
- Surfactant system, pH target, solvent restrictions, preservative system, fragrance, and packaging.
- Sample quantity, first commercial order, annual forecast, and preferred pack size.
- Required delivery date, destination, shipping terms, and shelf life required on arrival.
- Complete document list and any customer-specific specification.
- Known technical problems such as crystallization, haze, viscosity loss, color change, or microbial failure.
FAQ
What is the INCI name?
The INCI name is Piroctone Olamine. Verify consistent naming across the specification, COA, SDS, safety report, and finished-product ingredient declaration.
Is Piroctone Olamine water soluble?
ZLEY lists BIOCARE-OCT as soluble in alcohol. Formulators should develop a controlled premix and confirm compatibility with the complete shampoo rather than assuming direct dissolution in water.
How much should be used in shampoo?
ZLEY recommends 0.01%-0.5% for this grade. The final level must be selected through finished-formula efficacy, safety, stability, microbiological, claim, regulatory, and cost evaluation.
Can it be the only preservative?
Do not assume so. The complete formula and package must pass an appropriate preservative efficacy test and microbiological risk assessment.
Can a U.S. shampoo claim to treat dandruff with Piroctone Olamine?
Piroctone Olamine is not one of the active ingredients listed in FDA OTC Monograph M032. Obtain qualified U.S. regulatory advice before using dandruff-treatment, seborrheic-dermatitis, antifungal, or other drug-like claims.
Request a Sample and Technical File
Send ZLEY your target formula, market, use level, annual volume, solvent restrictions, proposed claims, and required documents. The technical and commercial teams can then provide a relevant sample, current specification, quotation, and formulation discussion.