Shaded Lines
A shaded line is a line of similar products that have the same composition, are sold under the same brand or trade name, and only vary by color.1 Only the following types of cosmetic products can qualify as a shaded line:2
- Eye makeup – eyebrow pencil, eyeline, eye shadow, eye lotion, eye makeup remoer, mascara, other eye makeup preparations.
- Makeup preparations (not eye) – blushers, face powders, foundations, body paints, lipstick, makeup bases, rouge, other makeup preparations.
- Nail polish and enamels
A shaded line can include both sets and single products and they would all have the same ingredient declaration.
Conventional Ingredient Declaration
A conventional ingredient declaration would mean that each product would have a unique label that listed the ingredient declaration in that particular product. Where there were several products in a package, the ingredients for each product would be listed separately.3
However, there are special provisions are made for shaded lines so that all the individual or sets of products can have the same label, so long as the only difference is in the colors used.
Combined Ingredient Declaration
The alternate order for the ingredient declaration takes into account ALL of the products in the shaded line. The ingredients are listed in the following order:4
- Ingredients present in ALL of the products at more than 1%, listed in descending order of predominance, based on the cumulative amount (percent) in all products;
- Ingredients, other than color additives, present in ALL products at 1% or less, listed in any order;
- Ingredients present in one or more products but not all products, identified by the product(s) which contain the ingredient;
- Color additives present in all products;
- Color additives present in some, but not all products, prefaced by “May contain.”5
Example
Let’s take an example of three lipsticks, made with mostly the same ingredients, and produced in three colors:
| Pink | Rose | Purple | |
|---|---|---|---|
| Castor Oil | ✔ | ✔ | ✔ |
| Jojoba Oil | ✔ | ✔ | ✔ |
| Chia Seed Oil | ✔ | ✔ | ✔ |
| Candelilla Wax | ✔ | ✔ | ✔ |
| Hydrogenated Soybean Oil | ✔ | ✔ | ✔ |
| Hydrogenated Coconut Oil | ✔ | ✔ | ✔ |
| Tin Oxide6 | ✔ | ||
| Synthethic Fluorphlogopite6 | ✔ | ||
| Iron Oxides | ✔ | ✔ | ✔ |
| Mica | ✔ | ✔ | |
| Titanium Dioxide | ✔ | ✔ | |
| Red 30 | ✔ | ||
| Carmine | ✔ |
-
Ingredients present in ALL of the products at more than 1%, listed in descending order of predominance, based on the cumulative amount (percent) in all products:
Castor oil
Jojoba oil
chia seed oil
candelilla wax -
Ingredients, other than color additives, present in ALL products at 1% or less, listed in any order:
Hydrogenated soybean oil
Hydrogenated coconut oil -
Ingredients present in one or more products but not all products, identified by the product(s) which contain the ingredient:
Tin oxide (Pink Lipstick)
Synthetic fluorphlogopite (Rose Lipstick) -
Color additives present in all products:
Iron Oxides -
Color additives present in some, but not all products, prefaced by “May contain.”7
Mica
Titanium dioxide
Red 30
Carmine
The final ingredient declaration could be used on ALL of the products, including individually packaged (single) products and sets of two or more products. It would read:
Ingredients: Castor oil, jojoba oil, chia seed oil, candelilla wax, hydrogenated soybean oil, hydrogenated coconut oil, tin oxide (pink lipstick), synthetic fluorphlogopite (rose lipstick), and iron oxides. May contain: mica, titanium dioxide, red 30, carmine.
When dealing with shaded lines, it is much easier to do a combined ingredient declaration that works on all of the products!
1 21 CFR 701.3(g)
2 21 CFR 701.3(g)(2)(ii) referencing 21 CFR 720.4(c)(3), (7) and (8)(v)
3 21 CFR 701.3(a)
4 21 CFR 701(f) and 21 CFR 701.3(o)
5 21 CFR 701(o) and 21 CFR 701.3(g)(2)
6 Tin oxide and synthetic fluorphlogopite are ingredients frequently included in color additive blends (such as colored micas) but are not actually, themselves, approved color additives for use in cosmetics. As such, they are placed in the ingredient declaration with the regular ingredients, not with the color additives.
7 21 CFR 701(o) and 21 CFR 701.3(g)(2)
