What Is It?
Red 28 (D&C Red No. 28) and Red 28 Lake are coloring agents. In cosmetics and personal care products, Red 28 is used in the formulation of soaps and detergnets, bubble baths, hair bleaches, hair conditioners, hair dyes and colors, makeup, and permanent waves. Red 28 Lake is used in the formulation of blushers, lipsticks, and other makeup products. Red 28 and Red 28 Lake are subject to certification by the Food and Drug Administration (FDA).
Why Is It Used?
Red 28 and Red 28 Lake impart color to cosmetics and personal care products.
Red 28 is a synthetic pigment sometimes referred to in general terms as a xanthene color. Color additives are classified as straight colors, lakes, and mixtures. Mixtures are color additives formed by mixing one color additive with one or more other color additives or non-colored diluents, without a chemical reaction. Red 28 is a mixture. Lakes, such as Red 28 Lake, are pigments which consist generally of an insoluble metallic salt of a certified color additive deposited on an inert substrate.
The Food and Drug Administration (FDA) has reviewed the safety of Red 28 and Red 28 Lake and determined that these ingredients may be safely used for coloring drugs cosmetics when they conforms to FDA specifications. Red 28 and its Lake are not permitted for use in products intended for use in the area of the eye. The Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) has deferred evaluation of this ingredient 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:
Link to FDA Code of Federal Regulations for Red 28 and Lakes
Red 28 and Red 28 Lake are listed as CI 45410 in the Cosmetics Directive of the European Union and may be used as coloring agents in all cosmetics and personal care products when they contain not more than 1% 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 2% 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid. When used in cosmetics and personal care products in the European Union, Red 28 and Red 28 Lake must be called CI 45410.
Link to the EU Cosmetic Regulation:
You can learn more about the regulation and labeling of colors at:
More Scientific Information
Certifiable color additives, such as Red 28 are used widely because their coloring ability is more intense than most colors derived from natural products; thus, they are often added in smaller quantities. In addition, certifiable color additives are more stable, provide better color uniformity and blend together easily to provide a wide range of hues. Certifiable color additives generally do not impart undesirable odors or flavors while color derived from foods such as beets and cranberries can produce such unintended effects. Certifiable color additives typically are available for use as either “dyes” or “lakes.” Dyes dissolve in water and are manufactured as powders, granules, liquids or other special purpose forms. Lakes are the water insoluble form of the dye. Lakes are typically more stable than dyes and are ideal for coloring products lacking sufficient moisture to dissolve dyes. Lakes are often used to form the coating of drug tablets. Red 28 is principally the disodium salt of 2′,4′,5′,7′-tetrabromo-4,5,6,7-tetrachlorofluorescein. In cosmetics and personal care products, Red 28 and Red 28 Lake function as colorants.
Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm
EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/