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Zinc oxide | CAS No: 1314-13-2 | GMP-certified suppliers
A medication that supports diaper dermatitis care, helps relieve minor skin irritations, and provides broad topical protection including shielding the skin from ultraviolet exposure.
Therapeutic categories
Primary indications
- For adjunctive treatment of diaper dermatitis
- Also, it can be used to treat minor skin irritations (eg, cuts, burns, and scrapes, poison ivy)
- Zinc oxide can be used in ointments, creams, and lotions to protect against sunburn and other damage to the skin caused by ultraviolet light
Product Snapshot
- Zinc oxide is an inorganic small‑molecule API supplied for topical formulations such as creams, ointments, lotions, and other cutaneous products
- It is used for barrier protection in diaper dermatitis, minor skin irritations, and topical photoprotection
- It is approved for use in the US and Canada
Clinical Overview
Pharmacologically, zinc oxide exhibits astringent, protective, and soothing actions when applied to the skin. These properties support reduction of superficial irritation, moisture-associated skin damage, and mild inflammatory responses. Its particulate nature enables reflection and scattering of UVA and UVB radiation, contributing to its long-standing use in sun-protection products.
The mechanism of action is primarily physical rather than systemic. Zinc oxide forms an adherent barrier film on the stratum corneum, limiting contact with irritants and reducing transepidermal water loss. This barrier effect creates a more stable microenvironment that supports natural epidermal recovery processes.
Systemic absorption following topical administration is minimal due to the compound’s low solubility and particulate characteristics. As a result, classical ADME parameters are not clinically characterized to the same extent as those of systemically active pharmaceuticals. When used on intact skin, systemic exposure is expected to be negligible.
Safety considerations center on local tolerability. Zinc oxide is generally well tolerated, though occlusive application over large areas may contribute to maceration in susceptible individuals. Use should be limited to external application, avoiding inhalation of fine powders. Toxicity risks are low when used as directed in dermatologic preparations.
Zinc oxide is incorporated in numerous over-the-counter barrier creams, diaper rash products, calamine formulations, and mineral-based sunscreens. For API procurement, sourcing should prioritize material with appropriate particle size distribution, controlled impurity levels, and compliance with pharmacopeial specifications to ensure consistent performance in topical dosage forms.
Identification & chemistry
| Generic name | Zinc oxide |
|---|---|
| Molecule type | Small molecule |
| CAS | 1314-13-2 |
| UNII | SOI2LOH54Z |
| DrugBank ID | DB09321 |
Pharmacology
| Summary | Zinc oxide functions as a topical barrier agent that protects damaged or irritated skin by forming an occlusive layer that limits moisture and external irritants. Its pharmacologic effects include astringent and soothing activity, as well as reflection of ultraviolet radiation through physical light scattering. These properties support its use in diaper dermatitis, minor skin irritations, and as a physical sunscreen component. |
|---|---|
| Mechanism of action | It acts by providing a physical barrier to prevent skin irritation and help heal damaged skin. |
| Pharmacodynamics | Zinc oxide has astringent, soothing and protective properties and is used in topical preparations for eczema, slight excoriations, wounds and haemorrhoids. It also reflects ultraviolet radiation and can be used as a physical sunscreen. |
ADME / PK
| Absorption | No significant percutaneous absorption from topically applied zinc oxide. |
|---|---|
| Half-life | Intended for local use only, no systemic absorption. |
| Protein binding | Intended for local use only, no systemic absorption. |
| Metabolism | Intended for local use only, no systemic absorption. |
| Route of elimination | Intended for local use only, no systemic absorption. |
| Volume of distribution | Intended for local use only, no systemic absorption. |
| Clearance | Intended for local use only, no systemic absorption. |
Formulation & handling
- Primarily formulated for topical use as an insoluble inorganic oxide; oral forms require dispersion or suspension strategies due to negligible solubility.
- Highly stable solid with minimal degradation risk; formulation focus is on uniform particle size distribution to ensure consistent opacity and barrier function.
- Oral zinc oxide products may be affected by dietary components that chelate zinc, so excipient selection should minimize interactions that further reduce bioavailability.
Regulatory status
| Lifecycle | The product remains under U.S. patent protection until 2028, indicating a mid‑stage lifecycle with limited generic exposure in its current markets. With commercialization focused in the United States and Canada, market maturity will increase as the U.S. patent expiry approaches. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Zinc oxide is a longstanding mineral UV filter with no single originator; branded sunscreen products use it as a functional ingredient rather than a proprietary API. These formulations are marketed across North America, reflecting broad global availability of zinc‑oxide–based sunscreens. The listed U.S. patent expiring in 2028 appears formulation‑specific, and its timeline suggests existing or imminent generic and multi‑supplier competition for zinc oxide itself, which is already widely commoditized. |
|---|
Safety
| Toxicity | Acute oral toxicity (LD50): 7950 mg/kg [Mouse]. |
|---|
- Exhibits low acute oral toxicity (mouse LD50 ~7950 mg/kg), but bulk powder can pose inhalation and mechanical irritation risks during handling
- Fine particulate form may cause transient eye, skin, or respiratory irritation
- Implement standard dust‑control measures
Zinc oxide is a type of Dermatics
Dermatics is a prominent subcategory within the pharmaceutical Active Pharmaceutical Ingredient (API) sector. It focuses on the development and production of APIs specifically designed for dermatological applications. These APIs play a crucial role in the formulation of various pharmaceutical products used in the treatment of skin disorders, including creams, ointments, gels, and lotions.
Dermatics APIs are meticulously developed to address specific dermatological conditions such as acne, psoriasis, eczema, fungal infections, and other related ailments. The APIs used in these formulations are carefully selected for their therapeutic efficacy, safety, and compatibility with the skin.
Manufacturers of Dermatics APIs employ rigorous quality control measures to ensure the purity, potency, and stability of their products. These APIs undergo extensive testing to meet stringent regulatory standards and pharmacopoeial guidelines. Additionally, the production processes adhere to Good Manufacturing Practices (GMP) to guarantee consistent quality and minimize the risk of contamination.
With the increasing demand for advanced dermatological treatments, Dermatics APIs are subject to continuous research and development. Newer APIs are being explored to enhance efficacy, minimize side effects, and improve patient compliance. The field of Dermatics APIs is characterized by innovation, as researchers strive to develop novel compounds and delivery systems that address unmet therapeutic needs.
In summary, Dermatics APIs are a vital component of pharmaceutical formulations used in the treatment of skin disorders. They undergo stringent quality control measures and are constantly evolving to provide effective and safe dermatological solutions.
Zinc oxide (Dermatics), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Zinc oxide API manufacturers & distributors
Compare qualified Zinc oxide API suppliers worldwide. We currently have 11 companies offering Zinc oxide API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Belgium | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Critical Minerals Refinin... | Producer | United States | United States | CoA | 4 products |
| Croda Europe | Producer | United Kingdom | United Kingdom | CoA, GMP | 5 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | CoA, GMP, ISO9001, MSDS | 170 products |
| Grillo-Werke AG | Producer | Germany | Unknown | CoA, GMP | 1 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Jost Chemical | Producer | United States | United States | CoA, USDMF | 14 products |
| L. Brüggemann GmbH | Producer | Germany | Unknown | CoA | 1 products |
| Pharm Rx Chemical Corp | Distributor | United States | Unknown | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Sakai Chemical Industry | Producer | Japan | Japan | CoA, JDMF | 1 products |
When sending a request, specify which Zinc oxide API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Zinc oxide API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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Technical
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Regulatory
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