New Year’s Resolutions – Check Your Labels!

With the New Year come New Year’s resolutions. Besides the old standbys to lose weight, eat better, exercise more, and reduce stress, how about a new one this year — review your product labels to make sure they are compliant with the regulations!  Eliminate the stress you might have from wondering whether your products would get quarantined if the FDA (or some other officious government agency) decided to check your labels or inspect your premises.

It doesn’t take much to check and see if they are compliant.  If they aren’t, well, then at least you know what to do about it and can schedule in the time necessary to take care of it.

Here’s what to look for:

Identity of the Product

  Is the product identity clearly stated on the front of the package?  

The product identity is what the product IS. The consumer should be able to tell what the product is so they know if it’s what they want to purchase.  It is important, especially if your product might be confused with something else such as a lotion bar that looks like soap, or a bath fizzy that looks like a cupcake.  It only needs one or two words.

Net Contents

  Are the net contents on the front?  

The net contents — that is, how much product is in the package — must go on the front of the package. For anything except the smallest packages (under 2 oz usually), the net contents need to be parallel to the bottom of the package, and within the bottom 30% of the front.

It may be tempting to put on the side or back because it looks better, but the net contents are required to be on the front.

  Is the net contents in the right measurement?  

For solid or semi-solid products, the net contents should be stated in avoirdupois (weight) ounces and grams (g). Both US and metric are required.

For liquid products, the net contents should be stated in fluid ounces (volume) and milliliters (mL).

  Is the net contents accurate?  

Keep in mind that if a bottle or jar is said to be a certain number of ounces (a four ounce jar, for example), it will hold four ounces by VOLUME, but how much it holds by WEIGHT depends upon what’s inside it. A fluffy cream, a lotion or a whipped soap will weigh less; salt or sugar scrubs may weigh more.  Don’t assume: measure the actual weight and put that on the label.

Where products have a variation in the weight because of the way the soap is cut or the bottle/jar is filled, weigh or measure! You can put a lower amount on the label than is actually in the package – but not more than is actually in the package. Be as accurate as possible.

  Is the net contents text large enough?  

For most products, the text of the net contents must be 1/8″ high.  That’s WAY bigger than you would probably like or expect.

Different fonts have different heights – even when they are the same “font size.”  Print out the label text and actually measure it with a good ruler.

If the text is in upper and lowercase (i.e. Net Wt. or Net Contents), then measure the height of the lower case “o”. Keep in mind that when the lower case “o” is 1/8 inch high, the capital letters are usually 1/4 inch high.  That’s pretty big.

If the text is in upper case only (i.e. NET WT or FL OZ), measure the height of the upper case “L”.

If you don’t have enough room, using all upper case will keep the size down somewhat.  You can also use “condensed” text (taller and skinnier), but it can’t be more than 3 times as tall as it is wide.

Business Name and Address

  Is the business name and address on the label?  

The business name and address is required on the label.  It is normally placed on the back, sides or bottom (not on the front).

  Is the legal business name used?  

The business name to put on the label is the LEGAL business name. Unless you have filed a “doing business as” or are registered as a partnership, corporation or LLC with your state, the business name is your personal name.  Generally, it’s the same name that is on your bank account.

  Is the physical business address used?  

The address should be the physical address where business is conducted. Even if you get your mail at a PO Box or a mailbox service, the business isn’t conducted inside that little box.  It’s at a physical address, and that’s what needs to go on the label.

The city, state and zip code are always required. The street address may be omitted if it is listed online.  See Street Address – Your Choices for additional info on what does and doesn’t qualify.

Ingredient Declaration (Cosmetics Only)

  Are the ingredients included?  

Ingredients are required on all cosmetic products.  Cosmetics include any products that are are applied to the human body to cleanse, beautify or make more attractive (lotions, creams, bubble bath, bath fizzies, nail polish, shampoo, soap, hair products, make-up, etc.)

  Are the components of blended ingredients listed individually?  

Where a blended ingredient has been used, each of its component ingredients must be listed individually in the ingredient declaration. For example, a lotion base, a preservative blend, or a blended color additive would need the ingredients listed individually. Your supplier should be able to  provide you with a list of the ingredients.

  Are the ingredients listed in the right order?  

List ingredients in descending order of predominance.  That is, the ingredient with the highest amount goes first, then the one with the second highest amount, etc. If you are using a blended ingredient, check with the supplier to determine how to accurately place the component ingredients in your total list.

As an alternative, you can list all ingredients present at more than 1% in descending order of predominance, followed by all the ingredients present at 1% or less–which can be listed in any order. In the alternate listing, color additives can go at the end of the list, regardless of amount.

Are the ingredients named correctly?  

Ingredients should be listed by their standardized cosmetic ingredient name (the “INCI” name).  So, for example, baking soda is listed as Sodium Bicarbonate, epsom salts are listed as Magnesium Sulfate, and lye is listed as Sodium Hydroxide or Potassium Hydroxide (as applicable).

[US ONLY] Botanical ingredient names — that is anything that comes from a plant — should be listed by the common English name. This is true even though the standardized international requirements are for the Latin name to be used.  If you want, you may include the Latin name in parenthesis.  Example: Lavender Oil or Lavender (Lavandula angustifolia) Oil.

  Is the ingredient declaration text large enough?  

The text of the ingredient declaration must be at least 1/16″ high, measuring the lower case “o” for upper and lower case text, or measuring the upper case “L” for all upper case text. As with the net contents, you can save some room using all uppercase text, especially if it is slightly condensed.

If the total surface area of the package is less than 12 square inches, then you can reduce the text size to 1/32″ in height.  As an example, a typical bar of soap that is 3.5″ x 2″ x 1″ (about 5 ounces) has a total surface area of 25 square inches (which counts the front, back, top, bottom and sides).

Color Additives (Cosmetics Only)

  Have you used approved color additives?  

Only color additives that have been approved for use in cosmetics may be included in a cosmetic product.  When a cosmetic product contains a color additive that is not approved, it is considered an adulterated product and is illegal to be sold in the US.

  Are any color additives used approved for the type of product?  

Some color additives are approved for use in cosmetics — but with limitations.  For example, some can be used generally, some are limited to external use, and some may not be used around the eyes.  Any product that uses a color additive that isn’t approved for that use (for example, using a color additive in eye make-up that is not approved for eye area use) causes the product to be considered adulterated and therefore illegal to be sold.

In Closing

Now the New Year is just getting started and you’re working on those New Year’s Resolutions, take a moment to look over your labels and make sure they are A-okay for 2019.

Comments

  1. Thanks for the valuable update. Making labels larger this year. If I can’t see it my customers can’t.

  2. I appreciate your helpful blog posts! When listing ingredients, is it ok to say what they are and then list the constituents? For example, when listing a preservative, many customers have no idea what the specific ingredients are. So it seems like it would be helpful to list it like this on the ingredient declaration (example is a basic lotion bar): shea butter, beeswax, coconut oil, fragrance, preservative (glyceryl monocaprylate, glyceryl monoundeclenate).

    1. Author

      You need to list the component of the preservative separately, not in parenthesis, and in the correct order where they go in the WHOLE. Luckily, with preservative, each component of an ingredient is very likely (should) be present at 1% or less, so they can go with other ingredients present at 1% or less IN ANY ORDER. Ingredients present at 1% or less are listed after the ingredients present at more than 1%.

      Although you might see it on products, information on the FDA website says that they don’t want additional information in the ingredient list (like what the ingredient is used for). So leave out the word “preservative” and just list the preservative components where they go in the overall ingredient list. This earlier post, Calculating Percentages for Blended Ingredients covers the handling of blended ingredients is much greater detail.

  3. Is there a list of what words can and cannot be used on labeling? (or in advertising) Like the word ‘moisturizing’ is a no-no! But I’d love to see a listing of key words that can’t be used.

    1. Author

      There is no list of words that can or can’t be used. It comes down to the INTENDED USE of the product.

      If you want a soap product to be exempt from the definition of a cosmetic, then you can’t make any claims for it (on the label or in advertising) that it does anything other than clean. (So “moisturising” would not be acceptable.)

      Cosmetics are intended to cleanse or improve appearance — so using words that communicate that purpose are fine.

      Drugs, on the other hand, are intended to alter the function or structure of the body or to prevent, diagnose, mitigate or treat “disease” (physical issues 0f any kind, really). So words that communicate that are not a good idea. Using the name of a disease or physical affliction and indicating that the product will somehow have an effect on it is also not a good idea.

      It’s not the words themselves, it is what the consumer reads into the words as what the product is intended to do.

      1. I understand that but it seems so odd that you can’t use ‘moisturizing’ but CAN use ‘hydrating’. I’m so very confused!

      2. Also…can you say it’s ‘safe to use’ ? Is the word safe turning it into a drug? Like…’safe to use on lips’.

      3. Author

        It is the intended use that determines whether it is considered a cosmetic or a drug. “Safe to use on lips” doesn’t say what the intended use of the product is.

        • “Cures cancer and is safe to use on lips” = drug.
        • “Safe to use for the treatment of xyz” = drug
        • “Makes you pretty and is safe to use on lips” = cosmetic.
        • “Great soap and it cleans … and is safe to use on lips” = soap.
  4. Hi Marie, awesome resource, thanks so much for your work. Would writing on a salve that it “protects and soothes minor fissures” be a cosmetic or a drug claim?

    1. Author

      Drug claim. “Protects” is altering the function or structure of the body (and also mitigating or preventing disease). “Minor fissures” are structure of the body and also something that is being treated. A product that is intended to protect and soothe minor fissures is definitely an unapporved new drug.

  5. Hello Marie! Thank you so much for your website and for your books! I’m so confused with “natural” colorants. I use clays, coffee grounds, turmeric, botanicals, and other “natural” ingredients for my soap. Your book says that most of these items are not approved for use in cosmetics. However, I see loads and loads soapmakers who use the same ingredients and claim their soap as cosmetic. Now I’m confused! Is there any way to use “natural” ingredients in soap-as-cosmetic and not to break the law? Thank you!

    1. Author

      First off, just because someone is doing something and getting away with it doesn’t mean that it is legal or correct.

      A color additive is something that changes the color of a cosmetic product. ANY color additive used in a cosmetic must be on the list of color additives that are approved for use in cosmetics. Most herbs, spices and other botanicals that will change the color of soap are NOT on that list.

      Soap, if it is exempt from the definition of a cosmetic (that is the bulk of it is the alkali salt of fatty acids (lye/oil/water) AND it is labeled and marketed only as “soap”) is not subject to the color additive restrictions that apply to cosmetics.

      However, if a soap makes any claim to improve the appearance or beautify, then it IS a cosmetic, and the restrictions apply.

      There is no way to legally use a “natural color additive” in a cosmetic.

  6. This is super helpful! Love your website and content! I have a quick question. I need a little bit more clarification on this comment from another one of your posts….

    “Neither the product name nor the product brand are required on the label. However, if a product name is used, it is important to note that the FDA regulations specifically forbid the use of an ingredient name in the name of the product.”

    Does this mean I can not name a product Amala Firming Balm if it has the herb Amala?

    Thanks for your support!

    1. Author

      Technically, that is correct – the product name (“Amala Firming Balm”) cannot contain the name of an ingredient (Amala).

      You can say that the product is a firming balm and that it contains amala – but the statement is supposed to be separate from the name of the product (it would be marketing text on the front).

  7. Where is the regulation that net weight must be located in a specific placement on the label? I’ve seen requirements about the size of the text, but haven’t come across regulations about the specific placement (bottom 30%, parallel to the bottom of the label, etc) in my research. If your label is round, how must the net weight be shown? In a curve (parallel to the bottom)?

    1. Author

      The federal regulation for the placement 21 CFR 701.13(f) (last sentence of the paragraph):

      “It shall be placed on the principal display panel within the bottom 30 percent of the area of
      the label panel in line generally parallel to the base on which the package rests as it is designed to be
      displayed.”

      It is also referenced in the Cosmetic Labeling Guide on the FDA website here: https://www.fda.gov/cosmetics/labeling/regulations/ucm126444.htm#clgj

      Finally, the same requirements are included in the National Institute of Standards and Technology Handbook (Uniform Packaging and Labeling Regulation) which has been adopted in part or in full by all states. You can find it here: https://www.nist.gov/sites/default/files/documents/2017/05/09/13-section-IVa-14-h130-final.pdf

      The requirement is that the net contents are parallel with the bottom of the PACKAGE (not necessarily the LABEL) … so they should be straight, even if the label is curved.

  8. Hi Marie,

    I am trying to start a new business and I have read both of your books which have been amazing! I can’t image trying to start a new business selling cosmetic products without having read your books first. So thank you for writing them. After reading both books and reading/searching through all of your blogs I still have a few clarifying questions.

    Did I understand correctly that a single ingredient can’t be used in EITHER the trade name or the product identifier/name? If I understood that correctly, am I allowed to list a single ingredient on the PDP to say something along the lines of “scented with Lavender essential oil to help relax and promote restful sleep”? Even though lavender is only one of four essential oils used for the scent (each essential oil is listed in the ingredients on the information panel)?

    This brings me to my second question. I see many companies providing information/descriptions of their products on the PDP. Is this allowed, or can I only provide descriptions/info. on the information panels?

    My biggest stressor is making sure my information and product descriptions fall within cosmetic standards and not an unapproved new drug. I have made a body cream (product identity name) with ingredients to help with Eczema and Psoriasis. I know I can’t use ANY medical terms (Eczema, Psoriasis) anywhere on my label. Therefore, would I be safe to say “helps to soothe red, inflamed, irritated and itchy skin with all natural moisturizers and is ultra-nourishing with shea butter, jojoba oil, coconut oil, and vitamin E oil”? (I saw the section in your book about defending why I think the product is considered all natural, so I am listing the ingredients I consider makes it natural). I have purchased some products from companies that their product identity is “for chest and sinus congestion” so I am hoping the words I have chosen, not for the product identity, but as additional descriptors will be ok.

    Thank you in advance for all of your help and time!
    Danielle

    1. Author

      I am glad the books were helpful to you!

      For COSMETICS, the name of an ingredient may not be included in the NAME of the product if there are two or more ingredients. There aren’t any restrictions for the trade name or the product identity.

      For SOAP (exempt from the definition of a cosmetic), the FTC has different rules which say that an ingredient may not be included in the IDENTITY of the product unless it is present at significant and functional levels (which are not definited).

      Other than the required information on the PDP and the few restrictions (as above), there is NOTHING that prevents you from putting all the “marketing text” you want all over your product … front, back, sides, top and bottom! Go ahead and market away!

      While psoriasis and eczema are obviously “medical” issues, so are inflamed, irritated and itchy. So that something that relieves inflamed, irritated or itchy skin is mitigating a medical issue — and so would be an unapproved new drug. “Redness” is a little more tricky … if it is COVERING the redness (as in make-up that evens out red blotchy skin), then it’s a cosmetic. But if it is TREATING or RELIEVING the redness (as in making it go away), then it’s a drug.

      Chest and sinus congestion are medical issues and a product that treats them would be a drug.

  9. Marie,
    My daughter, who just turned 13, is selling her homemade salve at our local farmer’s market this summer. One requirement is that we follow USDA rules, which I’ve never looked into before. She’s been selling to friends, family and at our local Christmas bazaar in the past. Now I’m thinking that the very name of her product “Tavia’s Healing Salve” might need to be changed. We have changed our wording on what people read about it, taking out the word healing when describing it, but I can’t figure out if we need to change the name. If so, what can we use? Just “Tavia’s Salve”? Is anything else allowed, like Tavia’s Soothing Salve”, which from some of the previous questions and answers looks like this is also making a claim? I’m finding your info helpful. Thanks so much!

    1. Author

      It comes down to the what the consumer thinks is the intended use – whether it is to “beautify and make more attractive” (cosmetic) or to treat, mitigate or prevent a disease, or to alter the function or structure of the body” (unapproved new drug).

      A “salve” is traditionally treatment of some kind (bruises, scrapes, itches, bites, etc) although the word can be used alone for a cosmetic if there are no other claims made. Once you add in “healing” – you have moved into an unapproved new drug because the consumer will likely feel that application of the salve is intended to heal whatever the issue is.

      Using “soothing” is a bit trickier since it doesn’t outright state that it will treat or mitigate, or that it will alter the function or structure of the body. However, since it’s a salve, the implication (based on tradition) is that it will treat … so “soothing” would likely be considered to “soothe” something that hurts like itches, bites, scrapes or bruises (making it an unapproved new drug).

      “Soothe” and “soothing” are used to describe things that ARE cosmetic — like bubble baths or relaxing things. But when combined with “salve” it’s likely to be taken the other way.

      (Also, remember these are FDA, not USDA rules.)

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