Quick Labeling FAQ

Here are some of the basics of labeling and the questions that frequently come up about the basic labeling.

What goes on the FRONT panel?

  1. Name. Your unique product name; the name that separates your lavender soap from someone else’s lavender soap.
  2. Identity.  What is the product? (soap, lotion, bubble bath, etc).
  3. Net Quantity of Contents.  How much actual product is there?  In both US (oz, pounds, pints, etc) AND metric (ml, grams, liters, kilos).

Cosmetics and non-cosmetic products have the same BASIC labeling requirements, but there are some differences. See Cosmetics vs Non-Cosmetics Requirements

Of course, other marketing type information can also go on the front panel of the package!

FOR COSMETICS, the name may not include the name of one ingredient if there are two or more ingredients in the product. See What’s in a Name?

FOR SOAP, the identity of the product may not include the name of one ingredient, unless that ingredient is present at a “substantial or significantly effective amount”.  See Using an Ingredient Name in a Product Name for a more detailed discussion.

The statement must be in both US Customary (ounces, pounds, fluid ounces, pints) AND in metric (grams, kilos, milliliters, liters). Liquid products are measured by volume; solid and semi-solid products are measured by weight. See Net Contents – Weight and Volume

It must be large enough text – usually 1/8″ high, measuring the lower-case “o” for upper and lower case text or the uppercase “L” for all upper case text. (For packages less than about 2 ounces, the text can be 1/16″ high.) See Net Contents Big Enough?

The net contents should be placed in the bottom 30% of the label, parallel to the bottom of the container.

What goes on the BACK or SIDE panels?

For all products:

  1. The business name and address of the responsible party.
  2. Directions for safe use (if applicable)
  3. The declaration of ingredients (Cosmetics only)
  4. Any required warning statements (Cosmetics only)

Again, you can use the side and back panels for additional marketing text touting the wonderfulness of your products and why a consumer should buy them.  Remember not to use any claims that could be construed as “drug” claims (see blog posts FDA Cracking Down on Cosmetic Product Claims and More on Product Claims for more info).

1. Business Name and Address

The address must include the full street address, city, state and zip code of the place where the product is manufactured OR the place where business is conducted (records kept, business decisions made, etc.)

IF the name used on the label is listed in a CURRENT phone or city directory (print or online) and the street address is included in the listing, then the street address may be omitted from the label (but the city, state and zip code are still required).

For NON-COSMETICS, the street address to be omitted on the label IF it is listed in a readily accessible, widely published, and publicly available resource, including but not limited to a printed directory, electronic database, or Web site.116 CFR 500.5(d)

While technically it only applies to all non-cosmetic products, including soap that is exempt from the definition of a cosmetic, it seems likely that the FDA would accept it as well. See Street Address – Your Choices.

No.  The actual physical address is required.

No. The address needs to be the “place where business is conducted.”  Obviously, you aren’t sitting in Kinko’s or the UPS store carrying out your business activities.

2. Directions for Safe Use

If there is something the consumer should know in order to use the product safely, that needs to be included on the label.

Not always. However, if there is something the consumer should know to use the product safely that must be included on the package.

How to apply the product. How often to use it. How to store it.

If the product might normally separate or change the way it looks, that could be included so the customer is not surprised or think something is wrong with the product.

If the tub will become slippery, that might be included.

3. Ingredient Declaration

An ingredient declaration is required for all cosmetic products. Ingredients are not required on soap that is not a cosmetic or on other non-cosmetic products.

Yes. The only possible exception is if the ingredient could be considered an “incidental ingredient.” See What are INCIDENTAL INGREDIENTS?

It is ALWAYS correct to list the ingredients in descending order of predominance from most present in the product to least present in the product.

The alternative order is to list all the ingredients that are present at more than 1% in descending order of predominance, then list ingredients present at 1% or less in any order, then list all color additives regardless of the amount. To be listed this way, the color additives must the approved for use in cosmetics and listed by their correct name.

Blended ingredients used in the product (such as pre-made bases or preservatives) must have their component ingredients listed in the ingredient declaration based on the percentage of use in the entire formula.

Infusions, extracts, and teas are blended ingredients. The liquid used should be listed in the ingredient declaration based on how much there is in the WHOLE.

For example, if you used 10 oz of olive oil in the infusion and added that to your product, and the total amount of the product batch was 100 oz, then the olive oil is 10% of the whole and should be placed in the ingredient declaration after items present at 11% and before items present at 9%.

The extract is listed based on the amount of the plant components that made it into the product. Usually it is less than 1% and can be listed in any order with the other ingredients present at 1% or less

Fragrances (whether fragrance oils or essential oils) may be listed as “fragrance” without identifying all the component ingredients in the fragrance blend.

Alternately, you may list fragrance components, such as essential oils, by their actual names.

Yes and no.

Outside the US, soap is a cosmetic and an ingredient declaration is required.

Inside the US, if the soap is a cosmetic, an ingredient declaration is required. If the soap is not a cosmetic (that is, exempt from the definition of a cosmetic) then an ingredient declaration is not required. See Ingredient Declarations for Soap (US Only)

Yes and no.

The INCI name is the officially and internationally accepted name of the ingredient. For example, the INCI name for “baking soda” is “sodium bicarbonate” and the INCI name for “lye” is “sodium hydroxide” (or “potassium hydroxide”).

YES, you should use the INCI name for ingredients. See What is INCI? for more information.

EXCEPT, in the United States, for BOTANICAL (plant-based) ingredients, you should use the COMMON ENGLISH NAME. You may use the international (INCI) name in parenthesis, but should not use it first. Examples of correct names for botanical ingredients in the US:

  • Lavender flower oil
  • Lavender flowers
  • Shea nut butter
  • Coconut Oil
  • Coconut (Cocis Nucifera) Oil
  • Hemp Seed Oil
  • Hemp (Cannabis Sativa) Seed Oil

Easiest way to figure it out is to use the Ingredient Lookup provided by the Handcrafted Soap and Cosmetic Guild. You’ll need to be a registered user (free) to access it.

No, not for cosmetics or soap that is a cosmetic. The oils and lye (or the saponified result) must be listed.

Example: Sodium hydroxide, coconut oil OR sodium cocoate.

Use the full chemical name “sodium hydroxide” or “potassium hydroxide.”

4. Warning Statements

Warning statements are required on:

  • Bubble bath
  • Feminine deodorant products (including some yoni products)
  • Suntanning preparations that do not contain sunscreen
  • Products containing alpha or beta hydroxy acids

Other Frequently Asked Questions

No.  If it is a “true soap” (made from oil and lye), AND the only claim is that it cleanses AND it is only called “soap,” it is exempted from the FDA cosmetic regulations (but not the basic consumer commodity labeling requirements).

If it is exempted from the FDA cosmetic labeling regulations, an ingredient listing is not required.  That doesn’t mean you can’t put an ingredient listing on the package, but it is not required, and isn’t regulated by the FDA rules for cosmetic ingredient declarations. See blog post Ingredient Labels for Soap for more info.

You cannot use the Organic symbol unless you are registered with National Organic Program.

You should not use the word “organic” on your front panel. See blog post What About “Organic” Cosmetics for more info.

You can identify organic ingredients in your ingredient declaration with an asterisk (*) and then place a footnote below that those are organic ingredients. Don’t use the word “organic” to describe the ingredients in the actual ingredient declaration. You can also state the percentage of organic ingredients in the product.

You still need to provide the consumer with the necessary information that would be required on the label.

Selling in person, you could put the information in signage and on a card to go with the product.

Selling online, put the information in the product description and also provide a card or documentation with the product when it is shipped.

Other questions?

If you have a question that isn’t answered here, please feel free to email me.This information (and more) is contained in Soap & Cosmetic Labeling and Navigating the Rules & Regs books.
Last updated June 14, 2022

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References

References
1 16 CFR 500.5(d)