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Creating FDA Compliant Labels

May 20 2024 – Essential Labs

Creating FDA Compliant Labels
Creating FDA Compliant Labels

As private label manufacturers, we believe it’s our responsibility to provide customers with guidance on label application protocols. This document outlines the standards employed at Essential Labs to consistently achieve precise label placement on your packaging.

Showcasing your Brand

Your labels have to do a lot of work to stand out on a shelf crowded full of products. Obviously your logo must maintain a prominent place on your label, but consider, too, how to display the bigger story—let your label express your vision. Does your product contain organic content? Is your product based on an ingredient like olive oil, lavender or honey? Are you a local merchant selling in local stores? Those marketing messages will need to shine through.
We highly recommend working with a professional designer with experience designing for the natural and sustainable market.

What to Include On Your Label

The US Food and Drug Administration (FDA) requires specific information on cosmetic labels. You can find a complete guide to these requirements on their website. There you will also find a guide to help you understand what the law requires. Briefly, US law requires labels to:

  • State “manufactured for (client’s name)” and must include your phone number and street address so your customers may easily identify and contact the distributor.
  • Ingredients must be declared in descending order of predominance. Ingredients present at a concentration not exceeding 1% may be listed in any order after the listing of the ingredients present at more than 1% in descending order of dominance. Color additives of any concentration may be listed in any order after the listing of the ingredients, which are not color additives. If you are importing to another country be sure to familiarize yourself with that country’s labeling regulations. They can vary dramatically from country to country.
  • The actual weight of the product, both in standard and metric (with metric first, so as to comply with EU requirements).
  • Warning statements needed or as required by law. For example, these are needed for bubble baths or products that contain AHA. The US Government Publishing Office provides guidelines here. Cosmetics Europe provides EU guidelines here.

Universal Product Code (UPC)

Many consumer fulfillment houses, like Fulfillment by Amazon, and larger retail stores require a Universal Product Code that they can scan as part of their inventory management process. You can learn more at GS1 US. You can keep up to date on Fulfillment by Amazon requirements here.

Best Practices for Consistent Labels:

  • We recommend a poly material, as opposed to paper, with a permanent adhesive and a resistant UV coating. Paper labels tear easily and are more susceptible to staining from oils and fingerprints during transportation, storage and on your retail shelf.
  • Make sure clear or frosted labels have an opaque liner, such as craft paper so the machine will see the eye mark.
  • UV-coat or varnish your labels to prevent scuffing of the labels in transport and handling. Your labels will look nicer longer, too, when your consumer is using your product with wet hands or in a wet environment like the shower.
  • Uncoated labels will be damaged by Essential Oils. Get samples of your label material to try with your product before committing to the production run.
  • Embrace your label company. Tell them how your final product will be used, the ingredients in it and the market you’re going to. They will help you find the best label for your brand and your product packaging.

Creating FDA Compliant Labels:

As we mentioned above, the FDA* standardizes cosmetic labeling laws under the authority of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). Please note that we always recommend that an attorney who is familiar with FDA rules performs a review of your labels, but we will try and guide you on the basics. For a more intensive understanding, please visit the FDA’s website here.

*If a product will be exported then it must also follow international regulations.

Typical Issues While Creating Compliant Labels

Let’s start out with some items that we find to be missing or listed incorrectly almost every time we review a customer’s labels, and then we will continue.

  • First is identifying the manufacturer or distributor AND how to reach them. This is often missing and absolutely required on the cosmetic label.
  • The second item we often find missing is the actual weight of the cosmetic in both standard and metric. The department of weights and measures requires these to be displayed on the label. One example is 2 oz (56.7 g) or 2 fl oz (59.14 ml). The net quantity of contents declaration must accurately reveal the quantity of cosmetic in the container in terms of weight, volume, measure, numerical count, or combinations of count and weight, volume or measure. Unless there is a firmly established, general consumer usage or trade custom to the contrary in your locale, the statement must be in terms of fluid measure if the cosmetic is liquid and in terms of weight if the cosmetic is solid, semi-solid, viscous, or a mixture of solid and liquid.
  • Not only must the ingredients be identified by a standardized name, but labels also require a mandated type size. Ingredients must be listed as 1/16″ OR 1/32″ (Labeling surface, less than 12 sq. in), while the contents must be listed as 1/16″ (PDP less than 5 sq. in.) OR 1/8″ (PDP 5-25 sq. in.) OR 3/16″ (PDP 25-100 sq. in.) and the warning statements must be listed as 1/16”

Required Warnings for Compliant Labels

  • When selling your product online or in your marketing materials, you must ALWAYS state the intended use of the product. With that said, there are some warnings that the FDA requires to be listed exactly as they are written in the 21 CFR 740 (please refer to the link from earlier).
  • Please note any claims you make must always be reviewed by your attorney on an annual basis. The reason for this is that “plant-based” and “clean beauty”, to name a few, which were so popular years ago, are now being attacked for truth in labeling.
  • An example of one is Feminine Deodorant Sprays. A feminine deodorant spray which, for the purpose of this regulation, is defined as “any spray deodorant product whose labeling represents or suggests that the product is for use in the female genital area or for use all over the body” must bear the caution stated below. The regulation further states that the use of the word “hygiene” or “hygienic” or similar words renders any such product misbranded. Caution–For external use only. Spray at least 8 inches from skin. Do not apply to broken, irritated, or itching skin. Persistent, unusual odor or discharge may indicate conditions for which a physician should be consulted. Discontinue use immediately if rash, irritation, or discomfort develops.
  • The other warning is for Foaming Detergent Bath Products. A foaming detergent bath product–also known as bubble bath product–is, for the purpose of this regulation, defined as “any product intended to be added to a bath for the purpose of producing foam that contains a surface-active agent serving as a detergent or foaming ingredient.” The caution stated below is required on the label of any foaming detergent bath product which is not clearly labeled as intended for use exclusively by adults. The following are two examples of label statements identifying a product as intended for use exclusively by adults: “Keep out of reach of children” and “For adult use only.” If the bubble bath product is intended for use by children, the phrase “Keep out of reach of children” may be expanded to further read “except under adult supervision.” The regulation further requires that the label “Shall bear adequate directions for safe use” of the product. Caution–Use only as directed. Excessive use or prolonged exposure may cause irritation to skin and urinary tract. Discontinue use if rash, redness or itching occurs. Consult your physician if irritation persists. Keep out of reach of children.

Questions for Your Filling House Labeling Compatibility

Just to name a few:

  • Love your look – work with your designer to make the label you want
  • Correct information including manufacturer contact info and INCI, and weight.
  • Label size and material
  • UV Coating
  • UPC Code if needed
  • Label and packaging compatibility check
  • Send them to the fill house of your choice or get to hand labeling! Ask your filling house what type of label setup they require before you print your labels. As an example, does their labeling equipment require a central 3” core, should the Label Direction number be “Unwind Direction 4,” with 1/8” separation.