Does lip balm have lead in it, and what is the limit?
Usually a trace. Tested lip balms ran from not detected to 1.39 ppm, under the 10 ppm US and Canadian figures. The limit by country, and what the tests can't tell you.
Most lip balms do carry a trace of lead, but far below any limit regulators have set. Nobody adds it on purpose: it comes in with the ingredients, as an impurity. The US Food and Drug Administration (FDA) tested five lip balms in 2010. Four had 0.70 to 1.39 parts per million (ppm), and the fifth was too low to give a figure. Nine lip balms sold in China averaged 0.0738 ppm in a 2021 study. A 2018 check of 19 lip balms in Bavaria found traces in just one. The usual limit is 10 ppm, the FDA's recommended maximum and Health Canada's figure. The EU sets no number. It bans lead as an ingredient and allows only traces that cannot be avoided, and German inspectors treat more than 2 ppm as avoidable.
Yes, usually a trace, and well under the limits. The lip balms in published tests ran from not detected up to 1.39 ppm. The limit is 10 ppm in the US (an FDA recommendation, not a law) and in Canada (Health Canada guidance). The EU and UK ban lead as an ingredient and accept only traces that cannot be avoided, with no number in the law. German authorities treat anything above 2 ppm as avoidable. No test can tell you about your own tube, so the figures describe the market, not a promise.
- Lead in lip balm is an impurity from the ingredients, mostly from minerals and pigments. It is never a listed ingredient.
- Every lip balm figure we found sits below 1.4 ppm. The highest result in the FDA's 400 product survey, 7.19 ppm, was a lipstick.
- The 10 ppm figure in the US and Canada is guidance. The US one is a draft recommendation and does not cover lip balms sold as drugs, such as SPF balms.
- The EU and UK set no number. They allow only traces that good manufacturing cannot avoid, and Germany reads that as 2 ppm or less.
- "Not detected" means below what the test could see, not zero. Different lab methods give different answers on the same product.
What "lead in lip balm" means
The FDA says lead "may occur as an impurity" in any cosmetic ingredient "due to its background presence in the environment". An impurity comes along with an ingredient; nobody puts it in by design. So a lip balm with lead in it is not a balm made with lead. It is one whose wax, oil or colour carried a tiny amount in.
Lead as an ingredient is banned: the EU and Health Canada both list it as prohibited. The limits in this article are for lead as an impurity, the only way it turns up in an ordinary lip balm.
The amounts are given in parts per million, or ppm: one part in a million by weight. For a solid such as a lip balm, 1 ppm is 1 milligram of lead in each kilogram (1 mg/kg). It is also 1 microgram in each gram, a microgram being a millionth of a gram. Studies use both units, and this page treats ppm and mg/kg as the same.
Where does it come from? The FDA says small amounts of lead are "more likely to be found in unprocessed mineral compounds such as talc and clay" than in other ingredients. It also says colour additives are allowed to carry 10 to 20 ppm of lead as an impurity. Cosmetics usually hold no more than about 20 percent colour, so the finished product ends up much lower. A plain balm of wax and oil has fewer of those sources than a tinted one.
What the tests found in lip balms
Lip balms have been tested far less often than lipsticks. Here is every lip balm result we could find and read.
The FDA's 2010 survey. A contract laboratory tested 400 lip products from US shops for the FDA. Its supporting document says that "based on the product names" they were 394 lipsticks, one lip gloss and five lip balms. The whole survey ranged from the detection limit of 0.026 ppm up to 7.19 ppm, with a mean of 1.11 ppm. Only two products were above 5 ppm. The FDA's published results table names the five lip balms:
- Mary Kay Tinted Lip Balm, shade Blush: 1.39 ppm
- Mary Kay Tinted Lip Balm, shade Rose: 0.83 ppm
- Mary Kay Tinted Lip Balm, shade Apricot: 0.80 ppm
- Mary Kay Tinted Lip Balm, shade Poppy: 0.70 ppm
- Wet 'n' Wild Mega Mixers Lipbalm, Bahama Mama: no figure given. It is the last row of the table, below a product at 0.03 ppm.
So the highest lip balm held about a fifth as much lead as the highest lipstick, and the four tinted balms sat close to the survey's average.
Two smaller FDA surveys. In 2011 and 2012 the FDA tested 30 more lip products, 29 lipsticks and one lip balm. Results ran up to 3.4 ppm, mean 1.0 ppm, with no separate figure for the balm. A fourth survey, in 2012 and 2013, tested 29 lip products, two of them lip balms. It used a nitric acid extraction, chosen as easier to handle, and every result was below what that method could measure.
Li and colleagues, China, 2021. A team in Wuhan bought 34 best-selling lip products from a Chinese shopping site: 12 lipsticks, 13 glosses and 9 lip balms, including Vaseline, Mentholatum and Burt's Bees. They measured lead by ICP-MS, a lab method that counts atoms of each element in a dissolved sample. The nine lip balms averaged 0.0738 mg/kg, and the highest was about 0.52 mg/kg. Across all 34 products, lead was not detected in about 41 percent.
Lip balms had the highest average of the three groups, but the team found no significant link between lead and product type. The balm group's standard deviation, a measure of spread, was 0.164, more than twice its mean, so the nine results were far from even.
The Bavarian food and health authority, 2018. The LGL, the state health and food safety authority in Bavaria, Germany, tested more than 230 cosmetics for heavy metals, including 30 lipsticks and 19 lip balms. Lead was found, in traces, in one of the 19 balms, and the authority called the lip balms free of heavy metal contamination. Eleven lipsticks had measurable lead, all under 2.0 mg/kg. The report gives no figure for each product.
A US thesis on children's lip balms, 2017. Julie Grunklee, at the University of Northern Iowa, tested 25 lip balms of the kind that appeal to young children. In her words, "Lead was present in all 25 lip balms analyzed in this study." Higher lead was significantly linked with character tie-ins, flavour, country of origin and "use under adult supervision" warnings. It was a convenience sample, products easy to buy rather than a planned cross-section. We could read only the abstract, so no figures from it are given here.
Lead in lip balm: the tests side by side
| Survey | Lip balms tested | Lip balm result | Whole survey |
|---|---|---|---|
| FDA, US, 2010 | 5 | 0.70 to 1.39 ppm (four), one with no figure | 400 products, 0.026 to 7.19 ppm, mean 1.11 |
| FDA, US, 2011 to 2012 | 1 | Not reported on its own | 30 products, up to 3.4 ppm, mean 1.0 |
| FDA, US, 2012 to 2013 | 2 | Below what the method could measure | 29 products, all below that level |
| Li and colleagues, China, 2021 | 9 | Mean 0.0738 mg/kg, highest about 0.52 | 34 products, 0 to 0.52 mg/kg, about 41% not detected |
| LGL Bavaria, Germany, 2018 | 19 | Traces in 1 of 19 | 30 lipsticks: 11 measurable, all under 2.0 mg/kg |
| Grunklee thesis, US, 2017 | 25 | Lead present in all 25 | Lip balms for children only |
Every lip balm with a published number sits below 1.4 ppm, under even the German 2 ppm guide value.
Why the same balm can test differently
The figures above are not all the same measurement. To measure lead, a lab first dissolves the sample in strong acid. The FDA's "total dissolution" method adds hydrofluoric acid, which dissolves silicate minerals such as talc, clay and mica. In 2007, a campaign group reported lead in lipsticks using a method that could not dissolve those minerals. When the FDA tested the same brands with its own method, every result came out higher. Lead held inside a mineral grain stays hidden unless the grain is dissolved.
Li's team used nitric and perchloric acid, with no hydrofluoric acid, so its results may not be directly comparable with the FDA's.
Then there is "not detected". Every method has a detection limit, the smallest amount it can tell apart from zero; in the FDA's 2010 survey it was 0.026 ppm. A result below it means the method could not see any lead, not that there is none. So a "lead-free" claim is hard to back up. A test can only say "below our limit", and the limit depends on the lab.
The limit by country
No country sets a limit for lip balm as such. Each sets one for cosmetics, or lip products, and a lip balm sold as a cosmetic falls under it.
United States: 10 ppm, recommended. In December 2016 the FDA published guidance for industry recommending a maximum of 10 ppm lead as an impurity in "cosmetic lip products" and externally applied cosmetics. Its supporting document says this covers "cosmetic lip balms" too. The guidance is not binding: FDA guidance documents "do not establish legally enforceable responsibilities". And the version on fda.gov is still headed "Draft, Not for Implementation". The FDA's consumer page also calls it draft guidance, and we found no final version on fda.gov.
The US guidance also leaves out "topically applied products that are classified as drugs". A lip balm with an SPF, or one sold to protect chapped lips, is an over-the-counter drug in the US and carries a Drug Facts panel. The 10 ppm figure does not reach it. Our page on cosmetic vs drug claims sets out where that line falls, and Vaseline vs ChapStick shows two real labels on either side of it.
Canada: 10 ppm, guidance. Health Canada's guidance on heavy metal impurities says impurities are "technically avoidable" when they exceed 10 ppm lead, 3 ppm arsenic, 3 ppm cadmium, 1 ppm mercury and 5 ppm antimony. The figures apply to all finished cosmetics, and keeping below them is "the manufacturer's responsibility". Health Canada can ask for test results if it suspects a risk, under section 16 of the Food and Drugs Act, on product safety. Our Canadian cosmetic labelling page covers the rest of the Canadian rules.
EU and UK: no number, traces only. Regulation (EC) No 1223/2009 lists "lead and its compounds" in Annex II, entry 289, the list of banned substances. Article 17 then allows the "non-intended presence of a small quantity" of a banned substance. It must come from impurities, manufacturing, storage or packaging, be "technically unavoidable in good manufacturing practice", and leave the product safe. The UK kept the same wording. So the law sets no figure, and the burden falls on the product's safety assessment, which our page on safety assessment and the CPSR explains.
Germany: 2 mg/kg guide value. Germany's federal consumer protection office (BVL) published updated guide values in October 2016, based on testing in 2010 to 2012. For cosmetics in general, more than 2.0 mg/kg lead is treated as technically avoidable. The figure is 5 mg/kg for powder make-up, blush, eye shadow, kohl and face paint, and 0.5 mg/kg for toothpaste. The old 1985 value was 20 mg/kg. These are guide values for enforcement, not a law, but 2 mg/kg is the strictest lead figure in this article.
China: 10 mg/kg. Li and colleagues give China's limit for lead in cosmetics as 10 mg/kg, the same figure as the US and Canada. The FDA adds that the International Cooperation on Cosmetics Regulation, a group of US, EU, Japanese and Canadian regulators, also recommends 10 ppm.
| Where | Figure | What kind of rule | Source |
|---|---|---|---|
| United States | 10 ppm | Recommended maximum, draft guidance, not binding; drug lip balms excluded | FDA guidance, December 2016 |
| Canada | 10 ppm | Above this is "technically avoidable"; guidance | Health Canada heavy metal guidance |
| EU and UK | No number | Banned as an ingredient; unavoidable traces allowed if safe | Regulation 1223/2009, Annex II and Article 17 |
| Germany | 2.0 mg/kg | Guide value for enforcement under the EU rule | BVL, 2016, as published by LGL Bavaria |
| China | 10 mg/kg | Limit for cosmetics | As stated by Li and colleagues, 2021 |
A worked case: one tube at the highest balm reading
Take a standard 4.25 g lip balm tube and suppose it holds 1.39 ppm lead, the highest lip balm figure the FDA published. Nobody tested this tube. It is the published figures, worked through.
- Lead in the whole tube. 1.39 ppm is 1.39 micrograms in each gram. Times 4.25 g, that is about 5.9 micrograms of lead in the entire tube.
- The same tube at the limit. At 10 ppm, the US and Canadian figure, the tube would hold 42.5 micrograms. At the German 2 mg/kg it would hold 8.5 micrograms. The FDA's highest balm is under both.
- How much reaches you in a day. The FDA works from an average of 24 mg of lip product applied a day, taken from published usage studies. At 1.39 ppm that is about 0.033 micrograms a day. Even then, it counts every milligram applied as swallowed, which overstates it.
- The FDA's own sum at the limit. At 10 ppm and 24 mg a day, the FDA puts adult intake at 0.24 micrograms a day. It estimates this would raise average blood lead by at most 1.2 to 2.3 percent, depending on the age group. That is "too small to be detected in typical routine blood analyses".
- A heavy user. The EU's heavy-user figure is 57 mg a day, as set out in how much lip balm do you swallow. At 1.39 ppm that gives about 0.08 micrograms a day, about a third of the FDA's figure for an average user at the 10 ppm limit.
Walked through like that, the published lip balm with the most lead sits inside every limit, at a daily dose far below the one the FDA judged would not pose a health risk. It does not prove that any other tube is the same.
Does a tinted or cheap balm have more lead?
Tint is the clearer of the two questions. The FDA names minerals such as talc and clay, and the colour additives, as the likeliest sources. Its four Mary Kay balms were tinted, and they sat close to the lipstick average. In Bavaria, the authority linked higher heavy metals in powder make-up to mineral ingredients such as kaolin and iron oxides. No survey has set clear and tinted balms side by side, though, so this is the direction of the evidence, not a measured gap.
If you want colour, the pigment is where the paperwork matters. Iron oxides for US cosmetics have a lead limit of their own, set out in iron oxides and mineral pigments. Mica has its own trace metal questions, covered in mica and pearl pigments, and clays in kaolin and cosmetic clays. Colour taken from art supplies has none of that paperwork for lip use, which is why colouring lip balm with crayons advises against it.
Price is a weaker guide. Li's team found no significant link between lead and price across its 34 products. A dearer balm buys other things, as our page do expensive balms work better argues, but not a lower lead figure that anyone has shown.
Lip balm and children
Children are the reason lead in lip balm gets asked about at all. Grunklee's thesis calls young children "the most lead-vulnerable population", and a flavoured balm invites licking or eating the whole stick. The FDA assumes children aged 12 or under use 10 percent as much lip product as adults, which it calls a "subjective estimate". That puts their intake at 0.024 micrograms a day at the 10 ppm limit.
The two studies that looked harder at children differ in tone. Li and colleagues modelled children who used lip balm. Lead from lip products had "no obvious influence" on their blood lead; background lead, from food, water, soil and air, was the main factor. Grunklee looked only at balms marketed to children. In some of her hypothetical scenarios, which allowed for a child eating a whole product, some balms predicted blood lead above 5 micrograms per decilitre. That was the CDC's level of concern she cites. Neither study tested a single child's blood.
For a child, pick a plain, unflavoured balm with no character tie-in. That avoids the features Grunklee linked with higher lead, and the flavour that invites eating it. Our page on lip balm for children covers the rest. If a child eats a whole stick, ingredients such as camphor are the more urgent worry, so call a poison line or a doctor.
If you make lip balm yourself
The limits apply to the finished product, so the sum to do is simple. Multiply each ingredient's lead figure by its share of the recipe, then add them up. A beeswax at 2 mg/kg lead, used at 14 percent, adds 0.28 mg/kg to the balm. Iron oxides for US cosmetics may carry up to 20 ppm lead. Used at 8 percent, the top of the range in our tinted lip balm formula, pigment at that ceiling would add 1.6 ppm. Together that is 1.88 mg/kg: far under 10 ppm, but close to the German 2 mg/kg.
The weak point is not knowing the ingredient's figure. For beeswax, only the food standard sets a lead limit, at 2 mg/kg, as beeswax grades shows. Ask suppliers for a certificate of analysis with a measured lead result, and keep it with your batch records. Sourcing ingredients lists what else to ask for. In the EU or UK your safety assessor will want those figures, since the law gives no number to fall back on.
So the pigment needs the most care. A measured lead figure on its certificate, not the legal ceiling, is what lets the sum come out low. Never use a pigment sold for art, soap or candles in a lip product.
Why the scare persists
Two answers circulate. One says lip balm contains lead and is dangerous. The other says a good lip balm contains none. The numbers show both are wrong.
The fear comes mostly from lipstick. A 2007 Campaign for Safe Cosmetics report, "A Poison Kiss", made lead in lipstick a news story, and lip balm got swept along. The FDA's response was the testing above. It found lead in nearly everything, but at low levels, and judged 10 ppm "readily achievable". Across its surveys of 685 products, every lip product was under 10 ppm, and only four other cosmetics were above it. "Contains lead" and "contains a harmful amount of lead" are different claims, and only the first is supported for ordinary lip balms.
The "no lead at all" answer fails the other way. The honest claim is "below the test's limit", and even the EU's ban allows traces that are "technically unavoidable". A brand that says its balm has zero lead is saying more than any test can show. And "the FDA limit" is often quoted as though it were law. It is a recommendation, still marked draft, and it does not cover SPF and other drug lip balms.
What this answer does not cover
These figures describe the products tested, in the years they were tested: eight FDA lip balms, nine from China, 19 from Bavaria and 25 from one thesis, 61 in all. A different batch, shade or factory can carry a different amount, and no figure here is a promise about the tube in your pocket. Only a lab test of that product can tell you.
The page covers lead only; cadmium, nickel and other metals have their own limits. It covers balms from ordinary shops. The FDA says some cosmetics from other countries contain lead at higher levels, and homemade balms coloured with art pigments are outside every survey above.
Last, this page does not judge what level of lead is safe for any one person. The FDA's 10 ppm figure rests on usage averages. Pregnancy, a young child who eats balm, or other lead sources at home all change the picture. If you are worried about lead exposure, ask your doctor or local public health service.
Frequently asked questions
Does lip balm have lead in it?
Usually a trace, as an impurity from the ingredients. The FDA's five tested lip balms ran from too low to give a figure up to 1.39 ppm. Nine balms from China averaged 0.0738 mg/kg. In Bavaria, lead was found in traces in one of 19 lip balms.
What is the FDA limit for lead in lip balm?
The FDA recommends at most 10 ppm lead in cosmetic lip products, lip balms included. It is guidance, not law, and the version on fda.gov is still marked draft. It does not cover lip balms sold as drugs, such as those with an SPF or a chapped lips claim.
Is lead allowed in lip balm in the EU?
Not as an ingredient. Lead and its compounds are banned under Annex II of Regulation 1223/2009. Article 17 allows only small traces that are technically unavoidable under good manufacturing practice, and only if the product stays safe. The law gives no number. Germany uses 2 mg/kg as its guide value.
Is the lead in lip balm dangerous?
At the levels found in tests, the FDA judges it is not. At its 10 ppm limit, it estimates an adult takes in 0.24 micrograms a day from lip products. That would raise average blood lead by about 1.2 to 2.3 percent at most, too little for routine blood tests to detect.
Can a lip balm be lead-free?
No test can show that. A lab can only say lead was below its detection limit, and that limit depends on the method. In the Chinese study, lead was not detected in about 41 percent of 34 lip products. Other studies found some lead in every product they tested.
Do tinted lip balms have more lead than clear ones?
The likeliest sources of lead, says the FDA, are minerals such as talc and clay and the colour additives. The FDA's four tinted balms read 0.70 to 1.39 ppm, near the lipstick average. No survey has compared clear and tinted balms directly, so there is no measured gap.
Sources and further reading
- US Food and Drug Administration, Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level, Guidance for Industry, draft guidance, December 2016, docket FDA-2014-D-2275.
- US Food and Drug Administration, Supporting Document for Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied Cosmetics, December 2016, sections IV to IX.
- US Food and Drug Administration, Limiting Lead in Lipstick and Other Cosmetics, with the initial and expanded survey tables, content current as of 22 November 2022.
- Health Canada, Guidance on Heavy Metal Impurities in Cosmetics, effective 20 July 2012, mercury figure amended to 1 ppm.
- Regulation (EC) No 1223/2009 on cosmetic products, Article 17, Traces of prohibited substances, and Annex II entry 289, text as published on legislation.gov.uk.
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit (LGL), Schwermetalluntersuchungen bei kosmetischen Mitteln, Ergebnisse 2018, with the BVL guide values of October 2016, updated 11 September 2019.
- Li Y, Fang Y, Liu Z and colleagues, Trace metal lead exposure in typical lip cosmetics from electronic commercial platform: investigation, health risk assessment and blood lead level analysis, Frontiers in Public Health 2021;9:766984.
- Grunklee J, Lead content of lip balms: A cross sectional convenience sample with exposure assessment estimating an average daily intake for young children, MA thesis, University of Northern Iowa, 2017 (abstract).
Reviewed and updated 11 November 2026. Spotted an error? Tell us and we will fix and log it.