Dimethicone

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Dimethicone and Methicone are silicone based polymers. The only difference between these two polymers is that the repeating unit of Dimethicone contains two methyl groups, while the repeating unit of Methicone contains one methyl group. Other Dimethicone and Methicone based polymers that may be used in cosmetics include Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C30-45 Alkyl Dimethicone, C24-28 Alkyl Dimethicone, C30-45 Alkyl Methicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearoxy Dimethicone, Stearyl Methicone, Stearyl Dimethicone and Vinyl Dimethicone.

In cosmetics and personal care products Dimethicone and related ingredients are used in the formulation of a wide range of cosmetic and personal care products including cosmetic creams and lotions, bath soaps, shampoo and hair care products. The most widely used ingredient in this group is Dimethicone.

The Food and Drug Administration (FDA) reviewed the safety of Dimethicone and approved its use as a skin protectant active ingredient in over-the-counter (OTC)drug products.

The safety of Dimethicone, Methicone Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C30-45 Alkyl Dimethicone, C24-28 Alkyl Dimethicone, C30-45 Alkyl Methicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearoxy Dimethicone, Stearyl Methicone, Stearyl Dimethicone and Vinyl Dimethicone has been assessed by the Cosmetic Ingredient Review (CIR) Expert Panel. The CIR Expert Panel evaluated the scientific data and concluded that these ingredients were safe for use in cosmetics.CIR Safety Review: The CIR Expert Panel reviewed the group of silicon polymer derivatives (Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C30-45 Alkyl Dimethicone, C24-28 Alkyl Dimethicone, C30-45 Alkyl Methicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearoxy Dimethicone, Stearyl Methicone, Stearyl Dimethicone, Vinyl Dimethicone) together because they are similar in composition and use. For this reason, the CIR Expert Panel was able to consider the scientific information available for all of the ingredients to support the review of the safety of these ingredients for use in cosmetics and personal care products. The CIR Expert Panel considered it unlikely that any of the silicone polymers would be significantly absorbed into the skin due to the large molecular weight of these polymers. The CIR Expert Panel also considered limited positive inhalation toxicity data and took into account the fact that only a few of the tested silicones were in aerosol formulations and were at very low concentrations. The CIR Expert Panel also considered that particles from cosmetic formulations containing these ingredients would not likely be inhaled because expected particle sizes would primarily be above the upper size limit for respirable particles.

Link to FDA Code of Federal Regulations regulation for Dimethicone
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...

Dimethicone, Methicone and the releated polymers may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive:
http://ec.europa.eu/enterprise/cosmetics/html/consolidated_d...

World Health Organization: The Joint FAO/WHO Expert Committee on Food Additives has established an acceptable daily intake level for Dimethylpolysiloxane (Dimethicone) of 0 to 1.5 mg/kg body weight. http://www.inchem.org/documents/jecfa/jecmono/v06je42.htm

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