Synthetic Wax

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Overview

What Is It?

Ozokerite, Ceresin and Montan Wax are mineral waxes, derived from coal and shale. Paraffin and Microcrystalline Wax are derived from petroleum. Emulsifying Wax, Synthetic Wax and Synthetic Beeswax are manufactured waxes. In cosmetics and personal care products, these waxes are used in many types of products including lipsticks, baby products, eye and facial makeup, as well as nail care, skin care, suntan, sunscreen, fragrance, and noncoloring hair preparations.

Why is it used in cosmetics and personal care products?

Ozokerite and other waxes thicken lipid (oil) portion of cosmetics and personal care products and help keep emulsions from separating into their oil and liquid components. These waxes lessen the brittleness of stick products and add strength and stability to lipsticks. These waxes also hold together the ingredients of a compressed cake.

Scientific Facts:

Ozokerite is a naturally occurring fossil wax found near soft shale. Most of the Ozokerite used in commercial applications is mined in Eastern Europe. Crude Ozokerite is black; after refining, its color varies from yellow to white. It hardens on aging and the hardness varies according to its source and refinement. Ceresin is a white to yellow waxy mixture of hydrocarbons obtained by purification of Ozokerite. Montan Wax is a wax obtained by extraction of lignite (woody coals). The crude wax is brown, but becomes white after purification. Paraffin and Microcrystalline Wax are distillation products of petroleum. Paraffin solidifies into plates, while Microcrystalline Wax solidifies into small, poorly defined needles. Emulsifying Wax is made from a mixture of cetyl and stearyl alcohol and polyoxyethylene derivatives of fatty acid esters of sorbitan. Emulsifying Wax is used in some drugs and is listed in the National Formulary (N.F.). When Emulsifying Wax used in a cosmetic or personal care product conforms to the standards listed in the National Formulary, it may be labeled as Emulsifying Wax N.F. Synthetic Wax is a blend of low molecular weight polymers of ethylene. Synthetic Beeswax is a blend of fatty esters, fatty acids, fatty alcohols, and high molecular weight hydrocarbons. The properties of Synthetic Beeswax resemble beeswax.

Safety

Safety Information:

The Food and Drug Administration (FDA) permits Paraffin to be used as an ophthalmic emollient in Over-The-Counter (OTC) ophthalmic drug products. FDA includes Ceresin, Montan Wax and Paraffin on its list of indirect food additives that can be used as components of adhesives. The safety of Ozokerite and the other fossil and synthetic waxes has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax, Synthetic Wax and Synthetic Beeswax were safe for use in cosmetics and personal care products. In 2003, the CIR Expert Panel considered available new data on Ozokerite and the other waxes and reaffirmed the above conclusion.

More safety Information:

CIR Safety Review: The CIR Expert Panel concluded that Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax, Syntethic Wax and Synthetic Beeswax have, at most, a potential for mild skin irritation and mild or no eye irritation. The CIR Expert Panel concluded that these waxes do not result in dermal sensitization.

When formulations containing these ingredients were tested, they produced no skin irritation and the formulations were not phototoxic.

FDA Code of Federal Regulations for Paraffin use in OTC ophthalmic drugs

FDA Code of Federal Regulations for Ceresin, Montan Wax and Paraffin use as an indirect food additive

Ozokerite and the other waxes may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.

More scientific Information:

Ozokerite, Ceresin, Montan Wax, Paraffin, Microcrystalline Wax, Emulsifying Wax, Synthetic Wax and Synthetic Beeswax are fossil and synthetic waxes. The word wax is applied to a wide variety of chemically different lipids, including mineral waxes, and petroleum waxes. Certain blends of chemicals useful for emulsification are sometimes referred to as emulsifying waxes. Waxes find uses in all types of cosmetics to impart high viscosity to emulsions and suspensions and to harden lipid-based materials, such as lipsticks and hair pomades. Waxes consist of an aliphatic series of straight-chain, branched-chain, and cyclic hydrocarbons, and some oxygenated resinous bodies.

Resources

Resources:

Find out more about the regulation of over-the-counter drugs:

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