The US FDA requires that ingredients of cosmetics must be
listed in descending order of predominance or concentration. This means that the ingredient with the
largest concentration is listed first, then the next largest, and so
forth. The first ingredient is usually the
vehicle, which is responsible to carry the other ingredients, creating the
actual suspension.
However, there are a few exceptions to this requirement.
1. Active drug ingredient(s)
If the cosmetic is also a drug, the active
drug ingredient(s) must be declared before declaration of the cosmetics
ingredients.
Some think that any ingredient in a cosmetic product noteworthy for its ability to improve skin is an “active” ingredient. However, this is actually not true since there are very specific rules around what ingredients are deemed “active” in cosmetics products.
Sec. 509 of the FD&C Act recognised that the product categories “drug” and “cosmetic” are not mutually exclusive. A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic. If this product claims to accomplish these through physiological activity or by changing the structure of the skin, it is also a drug.
Some think that any ingredient in a cosmetic product noteworthy for its ability to improve skin is an “active” ingredient. However, this is actually not true since there are very specific rules around what ingredients are deemed “active” in cosmetics products.
Sec. 509 of the FD&C Act recognised that the product categories “drug” and “cosmetic” are not mutually exclusive. A product intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance is a cosmetic. If this product claims to accomplish these through physiological activity or by changing the structure of the skin, it is also a drug.
2. Ingredients with less than 1% concentration
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 predominance.
3. Color additives
Color additives of any concentration may be
listed in any order after the listing of the ingredients which are not color
additives.
4. “And other ingredients”
The name of an ingredient accepted by FDA in
accordance with certain procedures as a trade secret need not be disclosed on
the label. In lieu of declaring the name of that ingredient, the phrase “and
other ingredients” may be used at the end of the ingredient declaration.
Now, the next question is how to estimate the concentration
of an ingredient in a skin care or cosmetic product. Read on to figure out the concentrations of
ingredients yourself.
How to Figure Out the
Concentration of an Ingredient in a Skin Care or Cosmetic Product?
You already know that the first listed ingredient is the most
concentrated ingredient in the product. This helps you determine the relative
concentration of each ingredient in the product. Note that it is impossible to determine the
exact amounts of each ingredient since disclosing that would reveal the company’s
formula.
Few common product ingredients can be used as a marker or
reference to estimate the relative concentration of the other ingredients.
- If water or aloe vera juice is the first ingredient on the label, it is likely that 75%-95% of the product is comprised of water.
- Emulsifiers (ingredients that hold the oil and water in mixture) are necessary if oil and water are combined in the product (like in lotions, foundations, cream, illuminators and moisturizers) – usually between 3% to 8%
- Fragrance is usually anywhere between .50% and 3% of the product. So if the ingredient is listed after fragrance, it is likely in less than 3% of the product.
- Vitamin C, unless otherwise listed on the label, is typically less than 1% of the product. Vitamin C creams tend to oxidize when exposed to light, heat, or air, so many companies will try to negate this effect by keeping vitamin C concentrations accordingly low.
- Buffers, such as EDTA, are usually present in less than 1% of the product.
- Unless otherwise listed, most products will contain 0.025% or less retinol. The weaker retinyl palmitate may be in higher concentration.
US FDA Cosmetics Labeling Guide
https://www.futurederm.com
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