FDA regulations (21 CFR 701.3) require an ingredient declaration on a cosmetic product. This post explains how you build that ingredient declaration from your master formulation.
Ingredient Order
The ingredient declaration can always list all the ingredients in descending order of predominance. That is always correct, but sometimes difficult to do.
The alternate order of ingredients is:
- All ingredients except color additives that are present at more than 1%, listed in descending order of predominance.
- All ingredients except color additives that are present at 1% or less, listed in any order.
- All color additives, regardless of the amount.
Creating the Ingredient Declaration
The ingredient declaration is based on your formulation. That’s where you start.
1. Create the ingredient list.
Your formulation is most likely separated into the order the ingredients are used. For the ingredient declaration, you need a list by PERCENTAGE OF WEIGHT in the whole.
If you have a formulation by the amount by weight, you can calculate the percentage by dividing each ingredient by the total amount. For the example below, for the water it would be 60 ÷ 150 = 0.4 = 40%.
IMPORTANT NOTE: This formulation is given as an example only. It is NOT a final, tested, useable lotion formulation.
By weight
- 60 oz – water
- 30 oz – calendula infused sunflower oil
- 15 oz – shea butter
- 15 oz – cocoa butter
- 12 oz – glycerin
- 6 oz – BTMS-25
- 3 oz – emulsifying wax NF
- 3 oz – essential oil blend
- 1.5 oz – cetearyl alcohol
- 1.2 oz – Optiphen
- 0.3 oz – lavender mica
- ——————-
150 oz – TOTAL
By Percentage
- 40% – water
- 20% – calendula infused sunflower oil
- 10% – shea butter
- 10% – cocoa autter
- 8% – glycerin
- 4% – BTMS-25
- 2% – emulsifying wax NF
- 2% – essential oil blend
- 1% – cetearyl alcohol
- 0.8% – Optiphen
- 0.2% – lavender mica
- —————–
100% – TOTAL
2. Calculate the components of blended ingredients
Blended ingredients cannot be included in the ingredient declaration. You have to separate out the individual components and determine their percentage in the whole. Infusions, teas, and extracts, commercial products, color additives, and fragrance blends are often blended ingredients.
a) Infusions, extracts, and teas
Infusions, extracts, and teas are created by soaking some type of botanical in a liquid (solvent) such as alcohol, water, or oil. The plant material is then removed, but some (probably invisible) component of the plant remains. The part that remains is correctly named “extract”.
The amount of extract is unquantifiable but is likely very small (certainly less than 1%). The amount of the liquid remains essentially the same.
- 40% – water
20% – calendula infused sunflower oil- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 4% – BTMS-25
- 2% – emulsifying wax NF
- 2% – essential oil blend
- 1% – cetearyl alcohol
- 0.8% – Optiphen
- < 1% – calendula extract
- 0.2% – lavender mica
b) Commercial products
Trade names cannot be used in the ingredient declaration.
Commercial products, such as emulsifiers and preservatives, are frequently blended ingredients. Often, the “INCI” name lists the component ingredients with “(and)”. While this is a good way to identify the ingredient, it is NOT acceptable in the ingredient declaration.
Typically the Safety Data Sheet or other information about the product will contain sufficient information to figure out the amounts of the components well enough to correctly list them in the ingredient declaration.
In our example, we have BTMS-25 and Optiphen which are blended ingredients.
BTMS-25
BTMS-25 is 25% behentrimonium methosulfate and 75% cetearyl alcohol. The formulation contains 4% BTMS-25. To calculate the amount, it is the percentage in the product times the percentage of the component.
For the cetearyl alcohol: 4% * 75% = 3% (the same as .04 * .75 = 0.03). That is then added to the cetearyl alcohol that was already in the ingredient list: 3% + 1% = 4%.
For the behentrimonium methosulfate: 4% * 25% = 1% (the same as .04 * .25 = 0.01)
Optiphen
This preservative is a blend of 55.6% phenoxyehtanol and 44.4% caprylyl glycol. Since the amount of Optiphen is already less than 1%, the components are less than 1%, so we don’t actually need to know the exact amount … it’s just less than 1%.
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
4% – BTMS-25- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 2% – essential oil blend
- 1% – behentrimonium methosulfate
1% – cetearyl alcohol0.8% – Optiphen- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula extract
- 0.2% – lavender mica
c) Color additives
Commercially purchased color additives are actually often several color additives blended together to get a unique color. “Colored mica” is commonly a blend since mica itself doesn’t actually have any color.
Your supplier should be able to provide you with a list of the components in your color additive. In our example, the lavender mica is actually a blend of mica, titanium dioxide, ultramarines, and manganese violet. Since these are all color additives, they go at the end of the ingredient declaration — regardless of the amount.
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 2% – essential oil blend
- 1% – behentrimonium methosulfate
- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula extract
0.2% – lavender mica- mica
- titanium dioxide
- ultramarines
- manganese violet
d) Fragrances
You have some options when it comes to fragrances because the components of a fragrance are protected — they do not need to be disclosed. Most commonly, the fragrance is just identified as “fragrance.” Note that even if it is made up purely of essential oils, it is still identified as “fragrance.”
However, if you know the components of the blend and you want to list them in the ingredient declaration, you can do so. In our example, the essential oil blend is 75% lavender essential oil and 25% chamomile flower essential oil.
“FRAGRANCE”
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
2% – essential oil blend- 2% – fragrance
- 1% – behentrimonium methosulfate
- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula extract
- mica
- titanium dioxide
- ultramarines
- manganese violet
LISTED
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
2% – essential oil blend- 1.5% – lavender essential oil
- 1% – behentrimonium methosulfate
- .5% – chamomile flower oil
- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula extract
- mica
- titanium dioxide
- ultramarines
- manganese violet
3. Verify ingredient names
In most cases, the name used to identify the ingredient should be that name adopted by the International Cosmetic Ingredient Dictionary and Handbook. This is often referred to as the “INCI” name, as it is normally the name accepted as the international standard.
There are some exceptions.
Emulsifying Wax NF
Emulsifying Wax NF is not included in the Cosmetic Ingredient Dictionary; it is listed in the National Formulary, which is one of the go-to resources if the ingredient isn’t in the Cosmetic Ingredient Dictionary. There are MANY products that are “emulsifying wax,” but ONLY those that meet the National Formulary formulation may be referred to as “emulsifying wax NF” in the ingredient declaration. To qualify, it must be a blend of cetearyl alcohol and a polysorbate. If the emulsifying wax you are using doesn’t meet that qualification, then the components in the blend must be individually listed.
Botanical Ingredients
In the US, the common English name should be used to identify botanical ingredients. The scientific name (as used internationally) may be used in parentheses, but is not required.
Note, however, that the FDA does not appear to be enforcing this requirement and seems to be accepting botanical ingredients listed using the international (scientific name) standard.
English Name only
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 2% – fragrance
- 1% – behentrimonium methosulfate
- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula extract
- mica
- titanium dioxide
- ultramarines
- manganese violet
With Scientific name
- 40% – water
- 20% – sunflower (helianthus annuus) oil
- 10% – shea (butyrospermum parkii) butter
- 10% – cocoa (theobroma cacao) butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 1.5% – lavender (lavandula angustifolia) essential oil
- 1% – behentrimonium methosulfate
- .5% – chamomile (anthemis nobilis) flower oil
- < 1% – phenoxyehtanol
- < 1% – caprylyl glycol
- < 1% – calendula (calendula officinalis) extract
- mica
- titanium dioxide
- ultramarines
- manganese violet
4. Reordering for better marketing
English Name only
- 40% – water
- 20% – sunflower oil
- 10% – shea butter
- 10% – cocoa butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 2% – fragrance
- < 1% – calendula extract
- < 1% – caprylyl glycol
- < 1% – phenoxyehtanol
- 1% – behentrimonium methosulfate
- mica
- titanium dioxide
- ultramarines
- manganese violet
With Scientific name
- 40% – water
- 20% – sunflower (helianthus annuus) oil
- 10% – shea (butyrospermum parkii) butter
- 10% – cocoa (theobroma cacao) butter
- 8% – glycerin
- 3% – cetearyl alcohol
- 2% – emulsifying wax NF
- 1.5% – lavender (lavandula angustifolia) essential oil
- < 1% – calendula (calendula officinalis) extract
- .5% – chamomile (anthemis nobilis) flower oil
- < 1% – caprylyl glycol
- < 1% – phenoxyehtanol
- 1% – behentrimonium methosulfate
- mica
- titanium dioxide
- ultramarines
- manganese violet
Ingredients that are present at 1% or less may be listed in any order. Sometimes you can re-order the ingredients in that group to make it look a little better.
5. Fragrance Allergens
At some point in the future, the FDA will issue regulations specifying which fragrance allergens will need to be included in the ingredient declaration. The FDA were supposed to publish the proposed rule in June, 2024, but then announced that it would be published in October 2024. We’ll see.
Once the list is published, there will be a time period for them to finalize the rule and then some additional time to allow manufacturers to update their labels.
Summary
These are the basic steps to creating an ingredient declaration.
If you need help with your ingredient declaration or just want to get a side-check, it’s one of the things I can do as part of my consulting services.
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