In the cosmetic industry, safety is a top priority. As consumer demand grows, brands must follow strict regulations to ensure safety and transparency. A key part of this compliance is the proper use of cosmetic warning labels. These labels are required by law and help inform consumers of potential risks. In this article, UCC will outline the key requirements for cosmetic warning labels according to the FDA and explain how they contribute to consumer safety.
1. General Requirements for Cosmetic Warning Labels
According to 21 CFR 740 (1) and (2), cosmetic products must carry warnings when they pose potential health risks. The business must prominently display these warnings and ensure they are easy to read, so consumers can easily spot them when purchasing and using the product. If the product omits the necessary warnings, it may be considered fraudulent under Section 602(a) of the FD&C Act, as it withholds critical information that could lead to serious consequences for users.
- FDA Label Visibility Requirements
The warning must stand out clearly on the label, making it noticeable to the consumer. The text should be bold and provide a high contrast against the background, with a minimum font size of 1/16 inch to ensure readability.
2. Specific Regulations for Cosmetic Warning Labels
2.1. Warning for Products with Unverified Safety
One of the most important warnings is related to products whose safety has not been verified. If a cosmetic product has not been proven safe, it must include the warning: “The safety of this product has not been determined.”
To consider a product safe, qualified experts must verify that the product does not harm consumers under normal usage conditions. In addition, the business conducts toxicity testing and other evaluations to ensure the product’s safety, including potential misuse scenarios. This helps to safeguard consumers from both typical and unintended use.
2.2. Aerosol Cosmetic Products: Special Cosmetic Warning Labels
Aerosol cosmetic products packaged in pressurized containers must display special warnings regarding safe use. These products can present risks if users do not follow proper instructions, such as eye irritation or fire hazards. Therefore, warnings on these products must include:
- “Avoid spraying in eyes” (for spray products).
- “Contains compressed gas. Do not puncture or incinerate. Do not store above 120°F. Keep out of reach of children.”
Additionally, if the product contains halocarbon or hydrocarbon propellants, it must carry an additional warning about the dangers of misuse, which could lead to injury or even death, especially if the user intentionally inhales or concentrates the product’s gas.
2.3. Women’s Deodorant Products: Special Warning
Deodorant products for women must include a special warning on the label to ensure safe usage. These products are often applied to sensitive areas and must carry instructions such as:
- “Warning – For external use only. Spray at least 8 inches away from skin. Do not spray on broken, irritated, or itchy skin. Persistent odor or unusual discharge may indicate a condition requiring consultation with a physician. Discontinue use if rash, irritation, or discomfort occurs.”
For products that do not use compressed gas propellants, the “spray at least 8 inches away” instruction may not be necessary.
2.4. Foaming Body Wash Products: Special Warning
Foaming body wash products must display specific warnings to ensure user safety. Excessive use or prolonged skin contact may cause irritation. Therefore, cosmetic warning labels should include:
- “Warning – Use as directed. Excessive use or prolonged contact may cause skin and urinary tract irritation. Stop using the product if rash, irritation, or discomfort develops. If irritation persists, seek advice from your physician. Keep out of reach of children.”
For products intended specifically for children, include the additional note, “Use only under adult supervision.”
2.5. Coal Tar Hair Dyes: Cancer-Related Warning
Hair dyes containing coal tar ingredients linked to cancer must display a clear warning. Specifically, these products must include:
- “Warning – Contains ingredients known to be absorbed through the skin and have been identified as carcinogenic in laboratory animals.”
Hair dyes containing substances like 4-methoxy-m-phenylenediamine (2,4-diaminoanisole) and 4-methoxy-m-phenylenediamine sulfate (2,4-diaminoanisole sulfate) must comply with this requirement.
2.6. Tanning Products: Special Warning
Tanning products that do not contain sunscreen ingredients must display a special warning to inform users that the product does not protect against sunburn. Therefore, the cosmetic warning labels should read:
- “Warning – This product does not include sunscreen and offers no protection against sunburn. Repeated exposure to unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other skin damage, even if you do not burn.”
The term “tanning product” includes gels, creams, liquids, and other topical products designed to create an aesthetic effect through exposure to UV radiation or by using approved colorants without UV exposure. However, it excludes products intended to protect the skin from the sun’s rays.
For more information: Cosmetic Product Labels: Ensuring Safety and Compliance
3. About UCC
UCC is a leading provider of FDA registration consulting services for cosmetic products. Specifically, we assist businesses in ensuring full compliance with the strict regulations of U.S. authorities. From supporting FDA registration to designing and writing FDA-compliant labels, we help your products access the U.S. market efficiently and safely. Moreover, our expert team ensures that all processes are completed accurately and promptly.
With a team of experienced experts, we are committed to delivering fast, accurate, and effective solutions. To receive detailed consultation, please contact us via email at admin@ucc.com.vn or call our hotline at +13 607 398 022. Let UCC help you bring your products to the United States market, safely and in full compliance with regulations.
