Eye Cosmetic Safety: FDA Guidance and Safety Checklist

Most eye cosmetics are safe when used correctly. But pay special attention to: infection risk , injury from applicators , and the use of unapproved color additives (color additives) . Keep it clean! Eye cosmetics are usually safe at the time of purchase, but if used improperly they can allow dangerous bacteria or fungi to grow in them. Later, when applied around the eyes, the cosmetic can cause infection. In a few cases, women have suffered temporary or permanent blindness from infections caused by eye cosmetics. See the “Safety Checklist” below to learn how to keep your eye cosmetics clean and prevent infection. Sometimes, even when a product is new, certain eye cosmetics can have contamination problems. The FDA has issued Import Alerts for cosmetics, including eye cosmetics, contaminated with harmful microorganisms. Don't share! Don't swap! Do not share or swap eye cosmetics with others — not even your best friend. Someone else's germs can be harmful to you. The “testers” in retail stores may pose an even higher contamination risk, because many people use the same sample. If you must try cosmetics in a store, be sure to use a disposable applicator, such as a clean cotton swab. Don't move! Applying makeup in a car or on a bus may seem like a time-saver, but resist the temptation — even if you are not the driver. If the vehicle jolts, brakes suddenly or is involved in a collision, you could injure your eye with a mascara wand or other applicator (for example, scratching the cornea). Even a minor scratch can lead to a serious infection. What's in it? Like any cosmetic sold at retail to consumers, eye cosmetics must declare their ingredients on the label under the regulations implementing the Fair Packaging and Labeling Act (FPLA). If you want to avoid certain ingredients, or compare ingredients across brands, you can check the ingredient list. A cosmetic sold at retail to consumers that does not bear an ingredient declaration is considered misbranded and is illegal in interstate commerce. For some very small packages kept in tightly compartmented display racks, a tear-off ingredient sheet may be provided next to the display. What color are you using? In the United States, the use of color additives is strictly regulated. Many colors approved for general cosmetics are not approved for use around the eyes. The FDA's import alerts for cosmetics containing illegal colors list some eye cosmetics. Stay away from kohl — and keep it away from children too! One color additive of particular concern is kohl (also known as al-kahl, kajal or surma). Kohl is used in some parts of the world to enhance the appearance of the eyes, but in the United States it is not approved for use in cosmetics . Kohl is usually composed of heavy-metal salts such as antimony and lead. People may assume that because kohl is traditionally used in some places, it must be safe; but there are reports linking the use of kohl to lead poisoning in children . An FDA import alert lists three main reasons for detaining imported kohl products: it contains unsafe color additives , making the product adulterated; the label falsely claims the product is “FDA Approved”; it lacks an ingredient declaration . Some eye cosmetics use the word “kohl” on the label only to indicate a shade, and do not actually contain real kohl. If the product label is compliant, you can check whether the colors declared on the label are on the FDA's list of colors approved for cosmetics, and confirm that they are also listed as permitted for use in the eye area . Want to dye your lashes? Permanent eyelash and eyebrow dyes/tints have caused serious eye injuries, including blindness. The FDA permits silver nitrate as a color additive for coloring eyebrows and eyelashes in professional-use-only cosmetics (21 CFR 73.2550). The restrictions on its use include: in viscous gel products, the silver nitrate content is at most 4% by weight . Such cosmetics containing silver nitrate are not suitable for people under 16 , and should not be applied for more than 1 minute . In addition, these products must not be distributed or sold directly at retail to consumers. The FDA has also issued import alerts for eyelash and eyebrow dyes containing coal-tar colors. Want to use false lashes or eyelash extensions? The FDA considers false eyelashes, eyelash extensions and their adhesives to be cosmetics, so they must meet the safety and labeling requirements for cosmetics. False lashes and extensions need to be held in place with an adhesive. Remember that the eyelids are very delicate, and allergic reactions, irritation or other injuries around the eye can be especially troublesome. Check the ingredients before using these adhesives. Having an adverse reaction? If a consumer has an adverse reaction to an eye cosmetic, first contact a medical professional. The FDA also encourages consumers to report cosmetic adverse reactions. Safety checklist If you use eye cosmetics, the FDA recommends following these safety tips: If any eye cosmetic causes irritation, stop using it immediately; if the irritation persists, see a doctor. If you have an eye infection or inflamed skin around the eye, avoid using eye cosmetics; wait until the affected area heals. Discard all eye cosmetics you used during the infection. Remember that there are bacteria on your hands that can cause infection if they get into your eyes; wash your hands before use. Make sure any tool that touches the eye area is clean. Do not share cosmetics; someone else's bacteria can be harmful to you. Do not let cosmetics gather dust or become contaminated with dirt; keep containers clean. Do not use eye cosmetics that are too old; manufacturers usually recommend discarding mascara 2–4 months after purchase. Discard dried-out mascara; do not thin it with saliva or water. Mouth bacteria can grow in mascara and cause infection, and adding water can also introduce bacteria and dilute the preservative system that inhibits microbial growth. Do not store cosmetics above 85°F (about 29.4°C). For example, cosmetics left for a long time in a hot car are more likely to suffer preservative failure or product deterioration. When applying or removing makeup, be careful not to scratch the eyeball or other sensitive areas. Never apply or remove makeup in a moving vehicle. Do not use cosmetics not intended for the eyes around the eye area. For example, do not use a lip liner as eyeliner; this could expose the eye to contaminants from the mouth, or to color additives not approved for use in the eye area. Avoid using color additives not approved for the eye area, such as “permanent” eyelash dyes and kohl. Take particular care to keep children away from kohl, because there are reports linking it to lead poisoning in children.