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Orange 4

What is it?

In cosmetics and personal care products, Orange 4 (D&C Orange No. 4) is used as a color in the formulation of a wide variety of products.

Safety Information

The Food and Drug Administration (FDA) reviewed the safety of Orange 4 and approved the use of this ingredient for coloring externally applied cosmetics (this does not include products intended for use on the lips or the eye area) and personal care products if it conforms to FDA specifications. FDA determined that this color may also be used in coloring externally applied drugs.

According to U.S. regulations, all Orange 4 that is 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 this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
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Why is it used in cosmetics and personal care products?

Orange 4 is used to color to cosmetics and personal care products.

Scientific facts:

Orange 4 is a synthetic pigment sometimes referred to in general terms as a monoazo color. Color additives are classified as straight colors, lakes, and mixtures. FDA defines straight colors as color additives that have not been mixed or chemically reacted with any other substance. Orange 4 is a straight color.

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