The teeth-whitening business worldwide is going up and up, and the products of the own label are on the frontline. However, compliance has never been so important as more brands gain entry into the market. Regulations for whitening products keep changing, especially in the US, EU, and UK, and every brand must stay ahead to ensure its products are both safe and legally approved.
In this guide, we’ve broken down the 2025 compliance checklist for private-label whitening pens. It helps you understand key labeling rules, ingredient restrictions and documentation essentials for each region.
Compliance is not paperwork; it is what creates a difference between trustworthy brands and others. It guarantees your whitening pens are safe, branded and of good quality so that the customers may go on using them without any fear.
Also, strict compliance helps to avoid punitive action against your brand, recall, or litigation. At Onuge, development of private-label whitening pens that are already in compliance with or beyond the US, EU, and UK standards is our specialty. That means less hassle for our partners and a faster time to market.
In the United States, the FDA (Food and Drug Administration) regulates the teeth-whitening pens as cosmetics or over-the-counter medicines based on the nature of the active ingredient.
Here's what you need to know:
Ingredient Safety: Peroxidases containing hydrogen peroxide or carbamide peroxide are to be within the FDA scaling limits to concentration (usually less than 6% to be ingested by the shopper).
Proper Labelling: Provide ingredient listings, instructions of use, cautionary information and the name of the manufacturer. Any false claims, such as instant whitening, are to be avoided.
Claims and Classification: If your pen claims to “treat or heal,” it may be classified as a drug requiring FDA pre-approval. Keep your claims cosmetic (e.g., “whitens surface stains”).
Packaging Integrity: Tamper-proof seals and child-safe closures are now best practices for all whitening products in 2025.
→ Quick Tip: Partnering with an experienced manufacturer like Onuge ensures your products comply with FDA expectations from day one, from formula to labeling.
European Union implements highly stricter cosmetic safety laws in regulative form (EC) No. 1223/2009, with the emphasis on the safety of the products and the transparency of the consumer information.
Key requirements for EU markets:
Authorized Ingredients: Hydrogen peroxide concentration must not exceed 0.1% for direct consumer sale. Products with up to 6% peroxide require dentist supervision.
Safety Evaluation: Cosmetic Product Safety Report (CPSR) that is obtained by a qualified toxicologist should be carried out on each product.
Product Information File (PIF): All the documentation (formulas or test data and IFUs (Instructions for Use)) is stored.
Labeling: It should include the name of the ingredients (INCI name), batch number or use of the product and address of importer/manufacturer. Everything must be in the native language.
CPNP Notification: You should initially register your product in the Cosmetic Products Notification Portal (CPNP) prior to selling your product.
Compliance Focus: Traceability and transparency. All whitening pens in the EU have to be accompanied by a piece of documentation, which proves that they are safe and have been labeled correctly.
After Brexit, the UK has proceeded to make its own cosmetic laws, which are the UK Cosmetics Regulation (Schedule 34 of the Product Safety and Metrology Statutory Instrument 2019).
Here’s what brands need for the UK market:
Responsible Person (RP): You should have a UK-based RP who will address compliance and communication with regulators of the product.
Registration UK SCPN: Registration of products is done via the portal, Submit Cosmetic Product Notification (SCPN).
Labeling Rules: Labels must be placed in the product name, list of ingredients, batch code, shelf life and instructions on using the product.
Peroxide Limit: As in the EU, over-the-counter whitening products may not contain more than 0.1% peroxide unless supervised by a professional.
Documentation: Have your product information file (PIF) on the local drive so that you can get it very quickly in case of any request by authorities.
By complying with these needs, you demonstrate to the UK consumers that your brand cares about their safety and transparency, which are the two values of the UK market.
No matter where you are shipping, be it Los Angeles, London or Berlin, the error of labeling can either hold up that shipment or impose fines. Every compliant whitening pen label should include:
Product name and intended use
List of ingredients (INCI format)
Manufacturer or distributor address
Country of origin
Batch number or expiration date
Warnings and safe-use directions
Net content (in both metric and imperial units)
Remember, packaging design must be clear, honest, and aligned with each region’s legal language.
Instructions for Use aren’t just about customer guidance; they’re also part of regulatory documentation. Well-written IFUs ensure users handle whitening pens safely and effectively.
Include these essentials:
Step-by-step application guide with illustrations, if possible
Frequency of use (For example: Use once a day, 10-14 days)
Contact warnings (For example: Do not put your lips or gums directly in contact with anything).
Storage instructions (For example: Store in a cool and dry place, not under the sunlight).
First-aid guidance (If irritation occurs, rinse thoroughly and discontinue use)
At Onuge, we provide ready-to-approve IFUs for every batch of private-label products, helping our partners save time during the compliance process.
It does not have to be a difficult task to remain compliant in three major regions. When you partner with us at Onuge, we simplify everything. Our private-label whitening pens are developed under international standards, meaning you start ahead of the curve.
We support brands with:
Custom formulations that meet regional limits (PAP, peroxide, or natural).
FDA, EU and UK submissions that are pre-verified.
Customizable packaging and labeling solutions that satisfy every market.
The 2025 compliance does not only mean a tick in the box, but also the assurance of safety and reliability of your brand that can be trusted. Unquestionably labeled and approved, fully documented, your own-label whitening pens can unquestionably shine in all markets.
At Onuge, we make compliance simple. Our global expertise, certified production, and ready-to-launch solutions help you save time and stay ahead. Ready to take your whitening brand worldwide? Contact Onuge today to create compliant, effective, and beautifully packaged whitening pens designed for success in 2025.
