Contains Nonbinding Recommendations 
Draft-Not for Implementation 
  
  
 
 
Lead in Cosmetic Lip Products and 
Externally Applied Cosmetics: 
Recommended Maximum Level 
 Guidance for Industry 
 
Draft Guidance 
 
This guidance is being distributed for comment purposes only. 
 
 
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to 
ensure that the agency considers your comment on this draft guidance before it begins work 
on the final version of the guidance, submit either electronic or written comments on the draft 
guidance within 60 days of publication in the Federal Register of the notice announcing the 
availability of the draft guidance.  Submit electronic comments to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.  All comments should be identified with the docket number listed in 
the notice of availability that publishes in the Federal Register.  
 
For questions regarding this draft document contact the Center for Food Safety and Applied 
Nutrition (CFSAN) at 240-402-1130. 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
 
December 2016  Contains Nonbinding Recommendations 
Draft-Not for Implementation 
 
Table of Contents  
 
 
I.    Introduction 
 
II.  Background 
 
III.  Discussion   
 
A.  Recommended Maximum Lead Level in Cosmetic Lip Products and Externally 
Applied Cosmetics   
 
B.  Exposure Assessment and Public Health Impact of Recommended Maximum Lead 
Level in Cosmetic Lip Products and Externally Applied Cosmetics 
1.  Exposure to Lead from Cosmetic Lip Products 
2.  Exposure to Lead from Externally Applied Cosmetics 
3.  Public Health Impact of Recommended Maximum Lead Level in Cosmetic Lip 
Products and Externally Applied Cosmetics 
 
C.  Enforcement Policy for Lead in Cosmetic Lip Products and Externally Applied 
Cosmetics 
 
  IV.  References 
 
 
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Lead in Cosmetic Lip Products and 
Externally Applied Cosmetics: 
1
Recommended Maximum Level   
Guidance for Industry  
 
 
This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
Administration's (FDA or we) on this topic.  It does not establish any rights for any person and is 
not binding on FDA or the public.  You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.  To discuss an alternative approach, 
contact the FDA staff responsible for this guidance as listed on the title page.  
 
 
I.  Introduction 
 
This guidance provides a recommended maximum level of 10 parts per million (ppm) for lead as 
an impurity in cosmetic lip products and externally applied cosmetics that are marketed in the 
United States.  FDA (or we) has concluded that a recommended maximum level of 10 ppm for 
lead as an impurity in cosmetic lip products and externally applied cosmetics would not pose a 
health risk.  We consider the recommended maximum lead level to be achievable with the use of 
good manufacturing practices and to be consistent with the 10 ppm maximum lead level for 
similar products recommended by other countries.  For additional discussion of the scientific and 
legal background and rationale underlying this recommended level, see Supporting Document 
for Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied 
Cosmetics (http://www.fda.gov/Cosmetics/GuidanceRegulation/GuidanceDocuments/ucm517327.htm). 
 
The issuance of this guidance supports our effort to limit human exposure to lead in finished 
FDA-regulated cosmetic products by educating new manufacturers who wish to enter the market 
and encouraging current manufacturers to continue to follow or improve on voluntary good 
manufacturing practices that limit trace amounts of lead as an impurity.  This guidance applies to 
cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied 
cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United 
States.2  This guidance does not apply to topically applied products that are classified as drugs or 
to hair dyes that contain lead acetate as an ingredient.    
 
                                                 
1 This guidance has been prepared by the Office of Cosmetics and Colors in the Center for Food Safety and Applied 
Nutrition at the U.S. Food and Drug Administration.   
2 Cosmetic lip products are applied to the mucous membrane and therefore are not considered externally applied 
cosmetics (See 21 CFR 70.3(v)).  
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FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background 
 
We regulate cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair 
Packaging and Labeling Act (FPLA).  These laws require that cosmetics marketed in the United 
States be safe under their intended and customary conditions of use, and be properly labeled.  
Cosmetics are not subject to pre-market approval by FDA.  However, pre-market approval is 
required for the color additives used as ingredients in cosmetics.  
 
Although we have not set limits for lead as an impurity in cosmetics, most listed color additives 
have specifications for lead as an impurity as part of our requirements for their safe use.  This 
guidance supports our effort to limit human exposure to lead in finished products by 
recommending a maximum level of 10 ppm lead as an impurity in cosmetic lip products and 
externally applied cosmetics. 
 
The International Cooperation on Cosmetics Regulation and regions such as Canada and the 
European Union have set a limit of 10 ppm for lead as an impurity in cosmetics based on 
considerations of a reasonably achievable level, scientific risk assessment, good manufacturing 
practices, technical feasibility, and appropriate analytical methods (Refs. 1, 2).  This guidance is 
consistent with those efforts. 
 
III. Discussion 
 
A. Recommended Maximum Lead Level in Cosmetic Lip Products and Externally Applied 
Cosmetics 
 
Between 2007 and 2009, FDA scientists developed and validated a total dissolution method for 
analyzing lead in lipstick and used this method to determine the lead content in a selection of 20 
commercially available lipsticks on the U.S. market (Ref. 3).  In 2010, using the same analytical 
method, we obtained results for lead content in 400 lipsticks and other cosmetic lip products 
available in the U.S., and in 2012, obtained similar results for an additional 30 cosmetic lip 
products (Refs. 4, 5, 6, 7).  Finally, between 2012 and 2013, we used a more common extraction 
method for determining lead in an additional 29 cosmetic lip products (Ref. 7).  The lead levels 
found in our surveys ranged from 0.026 ppm (the detection limit of the total dissolution method 
for the studies) to a maximum of 7.19 ppm in one lipstick.  The average lead concentration was 
1.09 ppm.   
 
Between 2011 and 2012, we used a total dissolution method to obtain results for lead content in 
120 externally applied cosmetic products available on the U.S. market, which included eye 
shadows, blushes, body lotions, mascaras, foundations, body powders, compact powders, 
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shaving creams, and face paints (Refs. 6, 7).  Between 2012 and 2013, we used the extraction 
method for determining lead in an additional 86 externally applied cosmetics (Ref. 7).  The lead 
levels found in our surveys ranged from 0.0084 ppm (the detection limit of the total dissolution 
method for these studies) to a maximum of 14 ppm in one eye shadow and one blush.  The 
average lead concentration ranged from below the detection limit in shaving creams to 4.6 ppm 
in compact powders.     
 
These surveys indicate that levels of lead in the cosmetic lip products and externally applied 
cosmetics we have sampled are for the most part well below 10 ppm, leading us to expect that 
this recommended maximum level is achievable by all manufacturers of these products.  
However, in our surveys, which do not necessarily reflect the full range of products that are 
currently on the market, a small number of samples had lead levels that exceed the maximum 
level we are recommending. Our goal is to ensure that cosmetic lip products and externally 
applied cosmetics do not contain lead as an impurity at levels that would pose a health risk.  We 
have determined that a maximum level of 10 ppm in cosmetic lip products and externally applied 
cosmetics would not pose a health risk, but we encourage manufacturers of these products to 
follow or continue to follow manufacturing practices that allow them to achieve levels of lead 
lower than 10 ppm whenever feasible. 
 
We have concluded that a maximum level of 10 ppm for lead as an impurity in cosmetic lip 
products and externally applied cosmetics should be readily achievable by manufacturers that 
source their ingredients appropriately and use good manufacturing practices.  Modern analytical 
capability permits determination of lead at ppm levels, thus enabling manufacturers to avoid the 
purchase of ingredients with unacceptably high levels of lead and to determine whether lead is 
introduced into their products during the manufacturing process. 
 
B. Exposure Assessment and Public Health Impact of Recommended Maximum Lead Level 
in Cosmetic Lip Products and Externally Applied Cosmetics 
 
As explained in more detail in our supporting document, the routes of exposure to lead from 
cosmetic lip products are incidental ingestion and dermal absorption and the route of exposure to 
lead from externally applied cosmetics is dermal absorption. To assess the exposure to lead from 
cosmetic lip products and externally applied cosmetic products, we assumed these products 
contain 10 ppm lead because, as noted above, that impurity level should be readily achievable by 
manufacturers.  Additionally, 10 ppm lead is consistent with the 10 ppm maximum lead level for 
similar products recommended by the International Cooperation on Cosmetics Regulation and 
regions such as Canada and the European Union.  
 
1. Exposure to Lead from Cosmetic Lip Products 
 
The composition of cosmetic lip products limits the ability for lead present as an impurity to 
diffuse from a product and be absorbed by the skin.  Therefore, dermal absorption of lead from 
cosmetic lip products is negligible, and we have concluded that systemic exposure to lead from 
these products is primarily by incidental ingestion.   
 
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We used an approach previously employed by FDA for estimating exposure to lead from food to 
estimate exposure to lead from cosmetic lip products (Ref. 8).  We estimated that maximum 
exposure to 10 ppm lead from a cosmetic lip product is 0.24 g/day for adults and adolescents 
age 13 years or older and 0.024 g/day for children age 12 years or younger (assuming that 
children age 12 years or younger use 10% as much of these products as adults) (Ref. 9).  We 
determined that the potential elevation of blood lead levels from 10 ppm lead in these products is 
too small to be measured in routine blood analysis and requires state of the art analytical 
technology (Ref. 10).  
 
2. Exposure to Lead from Externally Applied Cosmetics 
 
Dermal absorption of lead from externally applied cosmetics is very small.  Results for lead 
uptake by the skin were reported for four lead compounds that resemble cosmetic ingredients 
(Ref. 11).  Based on those data, we estimated that only a very small amount (0.41%) of the lead 
present as an impurity in an externally applied cosmetic is absorbed by the skin.   
 
The amount of exposure to lead as an impurity in externally applied cosmetics depends on 
whether the product is a leave-on product (such as eye shadow or body lotion) or a rinse-off 
product (such as shampoo or shaving cream).  The amount of exposure also depends on how 
much product is applied to the skin.  For example, eye shadows are applied in very small 
amounts (40 mg/day) and only around the eyes (Ref. 12).  Because dermal absorption of lead is 
so small, we estimated that exposure to 10 ppm lead from an eye shadow is only 1.64  10-3 
g/day for adults and adolescents age 13 years or older and 1.64  10-4 g/day for children age 
12 years or younger (assuming that children age 12 years or younger use 10% as much eye 
shadow as adults).  This means that exposure to lead from an eye shadow is approximately 150 
times lower than exposure to lead from a cosmetic lip product.   
 
The amount of exposure to lead as an impurity in a product such as body lotion is higher because 
average applications are higher (8.7 g/day) (Ref. 9).  Based on body surface area calculations 
from reported height and weight data, we estimated that children age 6-18 use 65% as much 
body lotion as adults age 19 and children age 1-5 use 34% as much body lotion as adults age 
19 (Refs. 10, 13). We then estimated that exposure to 10 ppm lead from a body lotion is 0.36 
g/day for adults age 19, 0.23 g/day for children age 6-18, and 0.12 g/day for children age 1-
5. In addition, our surveys found that body lotions actually contain very little lead (0.04 to 0.10 
g/g) (Refs. 6, 7).  Therefore, we estimated that exposure to lead from a body lotion containing 
0.10 g/g (0.10 ppm) lead is 0.0036 g/day for adults age 19, 0.0023 g/day for children age 6-
18, and 0.0012 g/day for children age 1-5, or 67 times lower for adults and up to 20 times lower 
for children than exposure to lead from a cosmetic lip product. 
 
Exposure to lead from externally applied cosmetics is up to 150 times lower than exposure to 
lead from cosmetic lip products.  Therefore, the potential elevation of blood lead levels from 10 
ppm lead in these products is too small to be measured in routine blood analysis and requires 
state of the art analytical technology (Ref. 10).  
 
3. Public Health Impact of Recommended Maximum Lead Level in Cosmetic Lip Products 
and Externally Applied Cosmetics  
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Based on our exposure assessment, we have concluded that a recommended maximum level of 
10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics would 
not pose a health risk.  The issuance of this guidance supports our effort to limit human exposure 
to lead in finished FDA-regulated cosmetic products by educating new manufacturers who wish 
to enter the market and encouraging current manufacturers to continue to follow or improve on 
voluntary good manufacturing practices that limit trace amounts of lead as an impurity.  We 
consider the recommended maximum lead level to be achievable with the use of good 
manufacturing practices and to be consistent with the 10 ppm maximum lead level for similar 
products recommended by other countries.   
Lead is a chemical element for which toxicity in humans has been well documented (Ref. 14).  It 
may occur as an impurity in any of the ingredients used in cosmetic lip products and externally 
applied cosmetics due to its background presence in the environment.  Cosmetics manufacturers 
are responsible for avoiding potentially harmful levels of lead in their finished products.  Our 
data show that over 99% of the cosmetic lip products and externally applied cosmetics on the 
U.S. market contain lead at levels below our recommended maximum level.  Therefore, we 
encourage firms to continue the manufacturing practices that achieve these lower levels of lead 
in their finished products. 
C. Enforcement Policy for Lead in Cosmetic Lip Products and Externally Applied 
Cosmetics 
FDA is prepared to take enforcement action against any cosmetic lip product or externally 
applied cosmetic containing lead at levels that may harm consumers.  FDA intends to consider 
several factors in bringing enforcement actions regarding lead in cosmetic lip products and 
externally applied cosmetics, including the level of lead present, the particular product, and the 
conditions of use for the product.  
IV. References
We have placed the following references on display in the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  You may 
see them at that location between 9 a.m. and 4 p.m., Monday through Friday.  As of December 20, 
2016, FDA had verified the Web site address for the references it makes available as hyperlinks 
from the Internet copy of this guidance, but FDA is not responsible for any subsequent changes to 
Non-FDA Web site references after December 20, 2016. 
1. International Cooperation on Cosmetics Regulation, Considerations on Acceptable Lead
Levels in Cosmetic Products, December 2013, available at http://iccrnet.org/topics/. 
2.Health Canada, Guidance on Heavy Metal Impurities in Cosmetics, July 20, 2012, available
at http://www.hc-sc.gc.ca/cps-spc/pubs/indust/heavy_metals-metaux_lourds/index-eng.php. 
3.Hepp, N. M., Mindak, W. R., and Cheng, J., Determination of total lead in lipstick:
Development and validation of a microwave-assisted digestion, inductively coupled plasma-mass 
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spectrometric method, Journal of Cosmetic Science, vol. 60, pp. 405-414, 2009. 
 
4. Hepp, N. M., Determination of total lead in 400 lipsticks on the U.S. market using a validated 
microwave-assisted digestion, inductively coupled plasma-mass spectrometric method, Journal 
of Cosmetic Science, vol. 63, pp. 159-176, 2012. 
 
5. U.S. Food and Drug Administration, Limiting Lead in Lipstick and Other Cosmetics, 
December 2016, available at 
http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm137224.htm.  
 
6. Hepp, N. M., Mindak, W. R., Gasper, J. W., Thompson, C. B., and Barrows, J. N., Survey of 
cosmetics for arsenic, cadmium, chromium, cobalt, lead, mercury, and nickel content, Journal 
of Cosmetic Science, vol. 65, pp. 125-145, 2014. 
 
7. U.S. Food and Drug Administration, FDAs Testing of Cosmetics for Arsenic, Cadmium, 
Chromium, Cobalt, Lead, Mercury, and Nickel Content, December 2016, available at 
http://www.fda.gov/Cosmetics/ProductsIngredients/PotentialContaminants/ucm452836.htm.    
 
8. Carrington, C. D., and Bolger, P. M., An assessment of the hazards of lead in food, 
Regulatory Toxicology and Pharmacology, vol. 16, pp. 265-272, 1992. 
 
9. Loretz, L. J., Api, A. M., Barraj, L. M., Burdick, J., Dressler, W. E., Gettings, S. D., Han Hsu, 
H., Pan, Y. H. L., Re, T. A., Renskers, K. J., Rothenstein, A.,, Scrafford, C. G., and Sewall, C., 
Exposure data for cosmetic products: lipstick, body lotion, and face cream, Food and Chemical 
Toxicology, vol. 43, pp. 279-291, 2005. 
 
10. Centers for Disease Control and Prevention, National Health and Nutrition Examination 
Survey, available at http://www.cdc.gov/nchs/nhanes.htm. 
 
11. Bress, W. C., and Bidanset, J. H., Percutaneous in vivo and in vitro absorption of lead, 
Veterinary and Human Toxicology, vol. 33, pp. 212-214, 1991. 
 
12. Loretz, L. J., Api, A. M. Api, Babcock, L., Barraj, L. M., Burdick, J., Cater, K. C., Jarrett, G., 
Mann, S., Pan, Y. H. L., Re, T. A., Renskers, K. J., and Scrafford, C. G., Exposure data for 
cosmetic products: Facial cleanser, hair conditioner, and eye shadow, Food and Chemical 
Toxicology, vol. 46, pp. 15161524, 2008. 
 
13. El Edelbi, R., Lindemalm, S., and Eksborg, S., Estimation of body surface area in various 
childhood ages  validation of the Mosteller formula, Acta Pdiatrica, vol. 101, pp. 540-544, 
2012. 
 
14. Centers for Disease Control and Prevention, Agency for Toxic Substances and Disease 
Registry, Toxicological Profile for Lead, available at 
http://www.atsdr.cdc.gov/ToxProfiles/tp13.pdf. 
 
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