Label Tips

How does the law define a cosmetic?
The Food, Drug, and Cosmetic Act(FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

How does the law define a drug?
The FD&C Act defines drugs by their intended use, as "(A) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease..and (B) articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

All cosmetic labels are required by law to have the following:
• You must identify the manufacturer or distributor (by name) of the product and have a way for the customer to reach them. Use company name, address and phone number.

• You must list the ingredients in the order that they appear in your formula. The ingredients must be identified by their botanical (INCI) name. A marketing description and use of the product is nice, as is the fragrance name, but it is not required unless the product use is not obvious or you are exporting to another country.

• The Department of Weights and Measures requires the actual weight of the product both in standard and metric to be disclosed on the label. Metric should be first to comply with EU requirements.

• Include any warning statements needed or required by law as with bubble baths or products containing AHA’s. IE: “Warning: Not for use in or around eyes.”

If we are making, packaging and labeling your products, please read the following.
• Labeling varies between a clear stock and a white stock for the base label. White labels are on a clear or semi opaque liner. This allows the label machine to distinguish where a label starts and stops by using a laser. Basically the laser “eye” can be set to “look” for these breaks in opacity.

• A clear or frosted label stock needs to have an opaque liner material like craft or white to create the opacity for the “eye” to bounce off. An eye mark is needed on the back of the liner to create a virtual label that tells the eye to start and stop the machine so 1 label will come off at a time. Otherwise the machine will continue to apply multiple labels on the same container.

• Application: Always assume the label will be applied by a machine. The liner your labels come adhered to needs to be strong enough to withstand the tension labeling machines create when applying your label. Ask for the thickest material your printer has in stock. This is usually discussed in “mils” or the weight of the stock.

Note: It is imperative for your label company make sure the right adhesive is used for your packaging.

This is vital!

• It is always a good idea to UV-coat or varnish your labels if they will be shipped or handled with wet hands. Also, paper labels should be coated with a UV or similar coating to avoid “scuffing” of the label in transport. It is preferable for toiletries with paper labels to have coating to guard against smearing when in contact with moisture. We will not be responsible for smeared or damaged labels. An uncoated label will almost certainly be damaged by an Essential Oil.
  
• We do not label tubes. Tubes require some very unique poly materials that allow for the flex when squeezed. You may want to consider screening any tubes. Contact us for a quote.

• Clear labels have a great shelf appeal and look professional, but they do have a few pitfalls, i.e. any surface flaw in the bottle will show, Dust, oils and fingerprints are all likely to cause poor adhesion.

• UPC Codes: Your label company can help you establish your UPC numbers. These are not required by law, but some larger retailers prefer that you have them. For more info check out their website for details at www.uc-council.org.

• We must see and approve the shape and size of your labels prior to price quoting and scheduling a production run. Odd shapes or larger sizes many not fit on our machine and may require hand labeling, which is more expensive, but possible.

• The label core size required to fit our machine is a 3” core. Label direction is number 3 with an 1/8” separation.

Let your label company know.

Ship the Labels to:
Essential Wholesale
8850 SE Herbert Court
Portland, OR 97015
Attn: Production Department

All private label items must comply with all federal, state, and local cosmetic labeling and packaging regulations. This is your responsibility however, we would be happy to answer any question you may have. Or See CFR 701 for details.