There is a lot more to the launch of a cosmetic product in the industry than its development, cosmetic packaging designs, and marketing. It is because there needs to be a proper FDA-approved cosmetic product label for them to sell well.
However, the legal label instructions approved by the FDA might be incomprehensible for the new beauty brands. That’s why we bring you a guide on FDA packaging and labeling requirements here.
So, stay tuned.
What are FDA Guidelines for Cosmetics?
To ensure every consumer knows what he/she is using, the FDA has devised a set of information that should be displayed on the product labels in layman’s language. This set of information about the product comes under the FDA’s guidelines for cosmetic labeling.
It includes information about,
- Product supplier and manufacturer
- Ingredients and their amount
- Quantity
- Product identity
- How to use instructions
- Warnings
FDA’s Legal Definition of Cosmetics
According to the FDA, “cosmetics are defined as any products other than soap intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance”.
Therefore, topical products like skincare products, grooming products, and makeup products all come under the heading of cosmetics.
When is Cosmetics Also Classified as a Drug aka Cosmecutical?
In the summary of cosmetic labeling requirements, the FDA says that some drugs can also be cosmetics. This is because the products used to treat and prevent diseases are “drugs”. However, products that make you appear as the best version of yourself are “cosmetics”.
So, the products that can do both are called cosmeceuticals. A few examples are anti-carry toothpaste, anti-perspiring sprays, sunscreens, and anti-dandruff shampoos.
Parts of Cosmetic Label
There are mainly two parts of a cosmetic label that you have to communicate with your cosmetic packaging supplier.
1. Principal Display Panel (PDP)
The label on the front of the cosmetic packaging is the principal display panel and it provides basic information about the brand name, product identity, net quantity, and any specific instructions about the product.
It takes 1 side of rectangular containers and 40% of the surface area of the containers of other shapes.
2. Information Panel (IP)
The information panel mainly has detailed information about the product and is printed on the back or sides of the product. This information includes,
- Directions about the use of the product
- Sourcing of the ingredients
- Ingredient list
- Benefits of the product
- Information about the brand
- Warnings
- Any other important thing to know
Why Is There a Need to Comply With FDA Cosmetic Labeling Requirements?
Although you might be aware that people trust FDA-approved products for safety reasons, here is how FDA-compliant labels can help cosmetics.
1. Ingredient Monitoring and Approval
Some ingredients are safe to be applied on the skin while others are not. Even when the ingredients are safe, their safety mainly depends upon the quantity used in cosmetic products.
FDA monitors the safety of the ingredients for usage in cosmetic products and labels them as such.
2. Full Disclosure and Transparency
FDA cosmetic labeling requirements enable cosmetic brands to display their complete ingredients in descending percentages on the labels. This transparency allows the consumers to know what they are using and also if the ingredient list satisfies the product claims.
3. Clear Usage Instructions to Avoid Misuse
As some products should be used at a particular time like day or night, some ingredients might react when used with other products like vitamin C and retinol, and a specific quantity of some products is recommended for use, clear usage instructions on the FDA labels help users avoid misuse of their favorite products.
4. Risk of Allergens and Toxic Substances
As ingredients like plant extracts, gluten, and more can cause hypersensitive reactions in prone consumers, FDA-complaint labels allow the user to know about it before buying and use it accordingly.
The same is true for other harmful substances used in cautious amounts.
5. Brand Reputation and Integrity
When a brand follows the guidelines of FDA regarding product development and labeling, it is more reliable for the consumers. Consequently, it helps in maintaining brand reputation and integrity.
Necessary Elements for FDA-Compliant Cosmetics Labeling
Here are the elements that an FDA-compliant cosmetic label must have. Cosmetic packaging manufacturers like VCPAK can help you incorporate all of these in cosmetic labels.
1. Product Name and Identity
The one thing that is displayed on the top of the cosmetic container in a large font is the product identity. It comprises the following things,
- brand/product name
- Cosmetic name
- Type of cosmetic
For example, In Neutrogena ultra sheer dry-touch sunscreen,
- Neutrogena is the name of the product
- Ultra sheer is a type of cosmetic
- Sunscreen is the name of a cosmetic
2. Net Quantity
The net quantity of the product is the amount of contents present in the cosmetic packaging. The contents are measured in an imperial system of measurement and can be written on cosmetic labeling in different units.
Below are some units and their abbreviations for measurement of the weight.
| Unit Terms | Abbreviation |
| Weight | wt. |
| Ounce | oz. |
| Pound | lb. |
| Fluid | fl. |
| Gallon | gal. |
| Quart | qt. |
| Pint | pt. |
| Fluid ounce | oz. |
| Weight ounce | Fl. oz. |
3. Manufacturer Information and Country of Origin
Just like product information, it is important to display the information about the manufacturing and origin of the product according to FDA labeling regulations. So, this information includes,
- English name of the country of origin
- Name of the business or brand
- The legal address of the brand
- Name and address of the manufacturer, packaging company, or distributed along with mentioning their role in cosmetics production
4. Declaration of Ingredients
As per FDA-labeling guidelines, the ingredient list is to be mentioned in full detail on the back of the product packaging. The guidelines suggest writing the ingredients with the highest ingredient list on the top followed by the ingredients in lower quantities.
After the key ingredients, the additives are placed at the end of the list and secret ingredients are mentioned in “other ingredients”. Also, names are written according to the nomenclature of one of the organizations given below,
- INCI
- USP
- USAN
5. Safe Usage Directions
In the case of products with active ingredients like retinol or exfoliating agents like AHA, the product has some directions for usage that limit the quantity and frequency of usage of the product.
Such directions are also to be displayed on the cosmetics labeling in clear words.
6. Any Associated Warnings and Claims
Some products might react when used together or need to be used in a certain way to be effective. Furthermore, some products are inflammable, some irritate the eye, some cause itching or skin redness, and some are intended for use in specific areas.
All such warnings should be written on the cosmetics labeling under the heading “warnings”. Moreover, it is important to ensure that you add no such claims on the cosmetics labeling that are similar to benefits provided by drugs.
Common Warning Requirements by FDA for Cosmetic Labeling
In addition to the warnings mentioned above, here are the details of some common warning requirements by the FDA cosmetic labeling guide.
1. For Children’s Safety
Children must not be given free excess to all products as they might eat them or spill them. So, if your product contains any ingredient harmful to children, add a warning saying “Keep out of reach of children”.
2. For Eye Safety
Aerosol sprays can irritate the eyes and so can some other cosmetic products if applied too close to the eyes. Therefore, a warning for eye safety “Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at a temperature above 120°F. Keep out of reach of children.” is to be written on cosmetic packaging.
3. Temperature Requirements
Most skincare and beauty ingredients should be stored in a specific range of temperatures as a lower temperature might make the contents freeze and a high temperature might cause product disintegration.
For such products, “store at a cool and dry place” or “store below 30 degrees Celsius” is written.
4. Content Pressure and Propellant Warning
Just like aerosol sprays, products with 10% propellants or hydro or halocarbon compounds should be used carefully. In such cases, “Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal” is the warning to use.
5. Tanning Products Without Sunscreen
Tanning products come with a side effect that they make skin more prone to being damaged by UV light. Therefore, some banners come with sunscreens. However, if our tanning products contain no sunscreen, it is important to mention that and its associated dangers in the product labeling.
6. Product Not Tested for Safety
While the safety testing for products with suspicious ingredients or ingredients that are only non-toxic in a certain quantity is essential, the testing might not be done for products with harmless ingredients.
Even for such products, must let the consumers know that by adding a warning, “The safety of this product has not been determined.”
Language Requirement for Cosmetic Labeling
Depending on the country where the product is distributed, the language requirements for cosmetic labeling differ. In general, English is the language of choice worldwide.
For Canada, the labels are in French and English. Similarly, Chinese, Korean, and Japanese products also have product labels in 2 languages.
What Are Cosmetic Claims According to the FDA?
Every other product you see in the beauty industry has claims like “alcohol-free”, “organic”, “dermatologist-approved”, “cruelty-free”, “vegan”, and more.
So, here is what such cosmetic claims mean according to the FDA labeling guide.
1. Alcohol-Free
In the cosmetic manufacturing market, “ethyl alcohol” is considered the only alcohol. If the product has other types of alcohols like cetyl, lanoline, or more, it is considered “alcohol-free”.
2. Organic Claim
Any product that is developed according to USDA instructions is organic. Some products include the ones with no ingredients that are grown on soil with pesticides, synthetic fertilizers, and without the use of yeast.
3. Cosmeceutical
While some cosmetic products work as drugs for the skin and hair, there is nothing like “cosmeceuticals” according to the laws in the cosmetic labeling industry. Thus, no product is really cosmeceutical as per FDA.
Best Practices for Staying FDA Compliant
Let us learn how you can stay compliant with the FDA.
1. Stay Updated on FDA Cosmetic Guidelines
Depending upon the research, experiments, and market demands, the FDA regularly updates its cosmetic labeling regulations. Therefore, it is essential to stay updated on FDA cosmetic guidelines to adjust their cosmetic formulation accordingly.
2. Attentive Ingredient Screening and Transparency
As the product is formulated with multiple ingredients, you have to look for the ingredients that are safe according to the FDA and use them in your products. Similarly, if there are any toxic ingredients or ingredients with no adequate information, it is best to skip them.
3. Adopting and Maintaining GMP
GMP or Good Manufacturing practices are the key to the concept of FDA-cleared cosmetics. It consists of product development, packaging, storage, selling, and transport procedures.
Adopting and maintaining GMP will automatically make your brand FDA-compliant.
4. Precise, Accurate, and Clear Cosmetic Labeling
While you are doing every step necessary to make your product an FDA complaint, if you are not using a precise, accurate, and clear label according to FDA guidelines, your product will lack essential information and won’t be considered efficient.
Thus, make an effort to create perfect FDA-compliant labels for your brand.
Example of an FDA Compliant Cosmetic Label
Here are two examples of FDA-compliant cosmetic labels.
In this Neutrogena label, the front of the label shows brand identity, product quantity, and major benefits while the back side has all the other information as recommended by FDA labeling guidelines.
Just like Neutrogena, the Natural Haus has designed their label according to FDA regulations. It also added some symbols to use less space and show more information.
Conclusion
FDA-compliant product labeling helps customers trust the cosmetic brand with its product’s ingredients, formulation, and packaging. IP and PDP being the two parts of FDA cosmetic labels are mentioned on the product packaging.
As FDA-complaint labels are written according to several official firms, you can ask VCPAK to create the most appropriate cosmetic product packaging for you.
