◆ Compliance · Lip Products · 2026
Lip Product
Regulations
◆ Short Answer
In the US, lip products may use only colors permitted on lips — “externally applied” colors such as ultramarines are not; SPF makes a lip balm an OTC drug; the FDA recommends ≤10 ppm lead (draft guidance); labels follow FPLA and MoCRA. In the EU, colorants follow Annex IV and microplastics in lip products end by October 2035.
By LuxeFormula Labs · October 3, 2026 · 7 min read
United States checklist
| Topic | Rule |
|---|---|
| Colors | Only color additives permitted for the use. “Externally applied” colors exclude the lips (21 CFR 70.3). D&C Red 33 and Red 36 are limited to 3% in lip products, D&C Orange 5 to 5%. |
| Certified colors | FD&C and D&C colors (e.g. Red 7, Red 40) must come from FDA-certified batches. |
| Lead | FDA draft guidance recommends no more than 10 ppm lead in cosmetic lip products. |
| SPF | Any SPF or sun-protection claim makes a lip balm an OTC sunscreen drug. |
| Drug claims | “Heals cracked lips”, “treats cold sores”, “increases blood flow”, “builds collagen” are drug claims. |
| Label | Identity, net quantity, ingredients in descending order (colors included), business name and place, adverse-event contact (MoCRA). |
| MoCRA | Facility registration and product listing unless the small-business exemption applies; safety substantiation and serious adverse event reporting always apply. |
European Union checklist
| Topic | Rule |
|---|---|
| Colorants | Only those in Annex IV of Regulation (EC) No 1223/2009, used within their conditions; field-of-use rules differ from the US. |
| Responsible Person | An EU-based Responsible Person, a Product Information File and CPNP notification before sale. |
| Microplastics | Intentionally added microplastics in lip products must be phased out by October 2035 (Regulation (EU) 2023/2055); some glitters count. |
| Flavor and allergens | Flavors declared as “aroma”; fragrance and flavor allergens above thresholds named on the label. |
The color trap most new brands fall into
Many pigments sold for eyeshadow or nail polish are listed only for “externally applied” use. Federal rules define that as excluding the lips, so the same blue or green that's legal in eyeshadow is illegal in lip gloss. Check each colorant in our lip color additive checker before you finalize a shade.
Claims: cosmetic or drug?
| Claim | Category |
|---|---|
| “Glossy shine” · “Moisturizes dry lips” · “Lips look fuller” | Cosmetic |
| “SPF 15” · “Protects against sunburn” | OTC sunscreen drug |
| “Heals cracked lips” · “Treats cold sores” | Drug |
| “Increases blood flow” · “Stimulates collagen” | Drug |
Not sure about your copy? Paste it into the free cosmetic claim checker.
FAQ
Lip Regulation
Questions
Color additives listed for "cosmetics generally" or specifically for lip use — for example iron oxides, mica, titanium dioxide, carmine, D&C Red No. 6, 7, 21, 22, 27, 28, 30, FD&C Red No. 40 and FD&C Yellow No. 5 and 6. D&C Red No. 33 and 36 are limited to 3% and D&C Orange No. 5 to 5% in lip products.
Ultramarines are listed only for "externally applied" cosmetics, and 21 CFR 70.3 defines externally applied as not including the lips. The same applies to ferric ferrocyanide, chromium oxide greens and aluminum powder.
No. In the US, a lip balm with SPF or sun-protection claims is an over-the-counter sunscreen drug and must meet OTC drug requirements.
The FDA recommends a maximum of 10 ppm lead in cosmetic lip products in draft guidance. The FDA has said levels it found are not a safety concern, and over 99% of products it tested were below 10 ppm.
Appearance claims such as "lips look fuller". Claims that it increases blood flow or stimulates collagen are drug claims.
Under MoCRA, businesses averaging under $1 million a year in US cosmetic sales may be exempt from facility registration and product listing. Labeling, safety substantiation and serious adverse event reporting still apply.
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Sources
- 21 CFR Part 74 Subpart C — Certified color additives (cosmetics)
- 21 CFR Part 73 Subpart C — Color additives exempt from certification (cosmetics)
- 21 CFR 70.3 — Definitions ("externally applied" excludes the lips)
- FDA — Lead in cosmetics (recommended maximum 10 ppm in lip products, draft guidance)
- FDA — Sunscreen: how to help protect your skin (sunscreens are OTC drugs)
- FDA — Is it a cosmetic, a drug, or both?
- FDA — Modernization of Cosmetics Regulation Act (MoCRA)
- European Commission — Restriction of intentionally added microplastics (EU) 2023/2055
General information, not legal advice.
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