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What You Should Know About Labeling Cosmetics and Drugs

October 31, 2016

Did you know that certain cosmetics are actually considered drugs? Instead of falling under the categories of cosmetics, personal care products, or cosmeceuticals, certain cosmetics fall under the drug category if they are meant to treat or prevent disease or affect the structure of the body, according to the United States Food & Drug Administration (FDA).

Depending on which category your personal care product falls under, your FDA labels should follow the correct rules and guidelines associated with each of the categories.  

What’s the Difference Between Cosmetics and Drugs?

If you’re in the pharmaceutical, cosmetics, or personal care product industry, you may be wondering where to draw the line between pharmaceuticals and cosmetics. While it may seem to make sense that your sunscreen or anti-dandruff shampoo be considered a cosmetic product, they’d both actually be considered a drug since these products are meant to affect the structure or function of the body and prevent or treat disease.

According to the FDA, drugs are defined as products that are meant to to prevent or treat disease, or affect the function or structure of the body. In addition to sunscreens and anti-dandruff shampoos, other personal care products that fall under the drug category include diaper ointments, antiperspirants, and acne treatments. Drugs must receive FDA premarket approval.

On the other hand, products such as nail polish, skin moisturizers (as long as they don’t contain SPF), perfumes, lipsticks, shampoo, makeup (as long as they don’t contain SPF), toothpastes, deodorants, and hair colors all fall under the cosmetics category. However, these products are not subject to FDA premarket approval, and instead must be legally regulated by the cosmetic company.

Can a Product be Both a Drug and Cosmetic?

Certain products fall under the drug and cosmetic category, including anti-dandruff shampoos, antiperspirants, or makeup and moisturizers that contain SPF. These products must abide by the regulations of both cosmetics and drugs.

Other products such as hair removal and microdermabrasion services may belong to other categories. The FDA doesn’t recognize a “cosmeceuticals” category.

How to Label Cosmetics and Drugs

There’s a lot of information to learn whenever FDA labels are involved, but it’s all to ensure the safety of your customers. Visit the FDA’s website to learn more about cosmetic product labeling requirements. If your product identifies with both a cosmetic and a drug, follow these guidelines for labeling over-the-counter products. Drugs should be labeled according to the FDA’s drug and over-the-counter guidelines.

At SheetLabels.com, we specialize in providing FDA labels to a wide range of markets and industries. Whether it’s cosmetic labels, chemical labels, food labels, or fitness industry labels, we can help! Our unmatched quality, excellent customer service, and fast turnaround time make us an excellent option for your labeling needs.

If you have any questions about our products and services, or if you’d like assistance during any part of the ordering process, please don’t hesitate to contact us for more information. We provide printed or blank labels to more than 50,000 customers nationwide. We know labels and we’re here to help you every step of the way! 

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