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For lip balm brands planning to offer sun protection, one of the biggest regulatory pivots comes when your product stops being just “cosmetic” and becomes an **OTC (Over-The-Counter) drug**. That change affects labeling, testing,…
For lip balm brands planning to offer sun protection, one of the biggest regulatory pivots comes when your product stops being just “cosmetic” and becomes an **OTC (Over-The-Counter) drug**. That change affects labeling, testing, and even your manufacturing site qualifications. This guide helps sourcing and formulation teams understand when SPF turns a lip balm into an OTC drug and how to manage “Drug Facts” labeling requirements from the start.
In the U.S., any lip product that claims **sun protection**, includes an SPF number, or makes any UV protection claim is regulated as an OTC sunscreen drug product under the FDA’s monograph (Title 21 CFR Part 352, though currently under reform for transition to new OTC frameworks).
Once SPF appears anywhere on-pack or in marketing, the formula must comply with sunscreen drug requirements—meaning tested active ingredients (like avobenzone or zinc oxide), stability data, and a proper “Drug Facts” panel are mandatory.
The “Drug Facts” panel structure follows specific formatting requirements. Below are the major elements and their placement sequence:
| Label Section | What Must Appear | Reference Notes |
|---|---|---|
| Active ingredient(s) | UV filter(s) listed by name and percentage | Must match COA and test batch formula |
| Purpose | “Sunscreen” | Exact wording per FDA monograph |
| Uses | “Helps prevent sunburn” and limited use claims | No cosmetic language crossover |
| Warnings | Includes “For external use only,” “Stop use if rash occurs,” etc. | Mandatory text; cannot be paraphrased |
| Directions | Application frequency and amount (e.g., “Apply liberally 15 minutes before sun exposure”) | Per monograph standard |
| Inactive ingredients | Listed as “Inactive ingredients:” using INCI names | Match formula and ingredient list |
When sourcing or developing SPF lip balms, request the following documentation early to avoid label rework or claims withdrawal:
No. Any sunscreen claim, explicit or implied, makes the product an OTC drug. The label must include SPF testing data and a Drug Facts panel.
Only if it’s the same formula and packaging, produced at the same registered site. Otherwise, fresh batch testing is required.
No. Even with cosmetic tints or flavors, if SPF or UV protection is claimed, OTC rules apply. Colorant use must also comply with FDA color additive regulations for drug-cosmetic combinations.
They still need OTC compliance if sun protection is claimed. Mineral actives (zinc oxide, titanium dioxide) are approved sunscreen ingredients but must meet label formatting and testing requirements.
Start stability and SPF testing in parallel with artwork design, and use templates of FDA-compliant Drug Facts panels to avoid rework later.
Request a Quote for SPF lip balm formulation, testing, and labeling support from LAEYO Labs.
With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.
