Red 27 Lake

What Is It?

In cosmetics and personal care products, Red 27 (D&C Red No. 27) and Red 27 Lake are colorants used in the formulation of blushers, lipsticks, foundations and other makeup products.

Why Is It Used?

Red 27 and Red 27 Lake color cosmetics and personal care products.

Scientific Facts

Red 27 is a color belonging to the fluoran class. The fluoran colors are characterized by fluorescence when exposed to light and tend to brighten the appearance of the product in addition to having a red hue.

Safety Information

The Food and Drug Administration (FDA) has reviewed the safety of Red 27 and Red 27 Lake and determined that they may be safely used for coloring cosmetics and personal care products, as well as drugs when conforming to FDA specifications. These ingredients are approved for use in products intended for use on the lips, but are not permited for use in products intended for use in the area of the eye. According to U.S. regulations, all Red 27 and Red 27 Lake manufactured for use in products is subject to certification by the FDA. This certification process ensures that the strict chemical and identity specifications set by FDA are met. Cosmetic Ingredient Review (CIR) has deferred evaluation of these ingredients because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.

All color additives used in foods, drugs and cosmetics in the United States must be approved by FDA and listed in the Code of Federal Regulations. In some cases, FDA requires that each batch of color produced for use in regulated products can be used only if it is certified by the agency to meet strict specifications. FDA maintains a laboratory especially for this purpose and color manufacturers must pay a fee to support this activity. FDA only approves colors after extensive review of all safety data and publication of the basis for its approval in the Federal Register.

You can find out more about FDA regulation of colors at: http://www.cfsan.fda.gov/~dms/cos-col.html

Link to FDA Code of Federal Regulations for Red 27

Red 27 is listed as CI 45410 in the Cosmetics Directive of the European Union and is a colouring agent allowed for use in all cosmetics and personal care products. 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid are limited to 1% and 2%, respectively. The various insoluble lakes, salts and pigments of Red 27 (Red 27 Lakes) are also permitted. When used in cosmetic products in the European Union, this ingredient must be called CI 45410.

Link to the EU Cosmetic Regulation: 
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

You can learn more about the regulation and labeling of colors at: 
http://www.personalcarecouncil.org/colors-cosmetics-regulation-and-nomen…

More Scientific Information

Red 27 is chemically named as 2′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein. As a fluorescein color, it exhibits fluorescence properties which means that the absorption of light triggers the emission of light with a longer wavelength. This can have the effect of making the product appear to glow. Fluorescence is named after the mineral fluorite, composed of calcium fluoride, which often exhibits this phenomenon. Red 27 is soluble in water at neutral or alkaline pH. Red 27 lake is an insoluble pigment used in applications where bleeding of the color is undesirable.