Food and Chemical Toxicology 43 (2005) 279–291

www.elsevier.com/locate/foodchemtox

Exposure data for cosmetic products: lipstick, body lotion, and

face cream
L.J. Loretz a,*, A.M. Api b, L.M. Barraj c, J. Burdick d, W.E. Dressler e, S.D. Gettings f,
H. Han Hsu g,1, Y.H.L. Pan h, T.A. Re i, K.J. Renskers j, A. Rothenstein k,
C.G. Scrafford c, C. Sewall l,2
a
Cosmetic, Toiletry, and Fragrance Association, 1101 17th Street NW, Suite 300, Washington, DC 20036, USA
b
Research Institute for Fragrance Materials, Woodcliff Lake, NJ 07677, USA
c
Exponent, Inc., Washington, DC 20036, USA
d
Bath & Body Works, Reynoldsburg, OH 43068, USA
e
Clairol Division, Procter & Gamble Co., Stamford, CT 06922, USA
f
Avon Products, Inc., Suffern, NY 10901, USA
g
Johnson & Johnson Consumer Companies, Inc., Raritan, NJ 08869, USA
h
Mary Kay Inc., Dallas, TX 75247, USA
i
L’Oreal USA, Clark, NJ 07066, USA
j
Takasago International Corp., Rockleigh, NJ 07647, USA
k
Unilever HPC, Edgewater, NJ 07020, USA
l
Procter & Gamble Company, Cincinnati, OH 45241, USA

Received 9 March 2004; accepted 18 September 2004

Abstract

Accurate exposure information for cosmetic products and ingredients is needed in order to conduct safety assessments. Essential
information includes both the amount of cosmetic product applied, and the frequency of use. To obtain current data, a study to
assess consumer use practices was undertaken. The study included three widely used cosmetic product types: lipstick, body lotion,
and face cream. Three hundred and sixty women, ages 19–65 years, who regularly use the products of interest, were recruited at ten
different geographical locations within the US. The number of recruits was chosen to ensure a minimum of 300 completes per prod-
uct type. Subjects were provided with prototype test products, and kept diaries and recorded detailed daily usage information over a
two week period. Products were weighed at the start and completion of the study in order to determine the total amount of product
used. Statistical analysis of the data was conducted to derive summary distribution of use patterns. The mean and median usage per
application, respectively, for the three products was: face cream, 1.22 g and 0.84 g; lipstick, 10 mg and 5 mg; and body lotion, 4.42 g
and 3.45 g. The mean and median usage per day for the three products was: face cream, 2.05 g and 1.53 g; lipstick, 24 mg and 13 mg;
and body lotion, 8.70 g and 7.63 g. The mean number of applications per day for face cream and lipstick was 1.77 and 2.35, respec-
tively. For body lotion, the mean number of applications per day was dependent on body area, and was 2.12, 1.52, 1.11, 0.95, 0.43,
0.26, and 0.40 for hands, arms, legs, feet, neck and throat, back, and other body areas, respectively. The effect of product preference
on use practices was also investigated. This study provides current cosmetic exposure information for commonly used products
which will be useful for risk assessment purposes.

2004 Elsevier Ltd. All rights reserved.

*
Corresponding author. Tel.: +1 202 331 1770; fax: +1 202 331 1969.
E-mail address: loretzl@ctfa.org (L.J. Loretz).
1
Ortho McNeil Pharmaceutical, Raritan, NJ 08869, USA.
2
Merck & Co., Inc., Whitehouse Station, NJ 08889, USA.

0278-6915/$ - see front matter
2004 Elsevier Ltd. All rights reserved.
doi:10.1016/j.fct.2004.09.016
280 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291
Keywords: Cosmetics; Exposure; Risk assessment
1. Introduction
Cosmetic products are widely used and are directly
applied to human skin. While the skin provides a protec-
tive barrier, certain ingredients may penetrate the skin
and become systemically available. Some cosmetic prod-
ucts are applied to mucous membranes which may en-
hance availability or, in the case of lip products,
provide the opportunity for oral ingestion. As such, an
evaluation of their safety is of utmost importance.
Safety assessment requires knowledge of both the intrin-
sic hazard of ingredients contained in the product as
well as data on exposure levels. Published or otherwise
readily available exposure data for cosmetic products
are limited at present (EPA, 1997; ECETOC, 1993).
The present study was undertaken to help fill that
data gap. The study was designed to generate robust
exposure data that could reliably be used in evaluating
the safety of cosmetic ingredients. The key objective of
the research was to determine distribution of product
usage by consumers in terms of frequency and amount
and patterns of consumption for each of three com-
monly used cosmetic products. The three products cho-
sen for the study were lipstick, body lotion and facial
cream. The data will be of value in the formulation of
cosmetic products, and to regulatory agencies concerned
with the safety of cosmetic ingredients. The information
will also be useful to the Cosmetic Ingredient Review
Expert Panel, an industry-sponsored independent group
of experts who conduct reviews of cosmetic ingredient
safety (Bergfeld and Andersen, 2000).
2. Materials and methods
2.1. Study design
A mall intercept design was used to identify study
subjects. The study was carried out by Pragmatic Re-
search, Inc. (St. Louis, MO). Thirty subjects in 10 geo-
graphically dispersed markets were included per
product, to ensure a mix of regional weather and
respondent usage differences. Actual recruitment targets
were 36 subjects in each market to allow for drop-outs.
Subjects were recruited in the following cities: Atlanta,
GA; Boston, MA; Chicago, IL; Denver, CO; Houston,
TX; Minneapolis, MN; St. Louis, MO; San Bernardino,
CA, Tampa, FL; and Seattle, WA.
The field portion of this study (product placement/
usage) was conducted from mid-April through early
June, 2000. Female respondents were recruited using a
screener that ensured respondents used two or more of
the test products and did not have known allergies.
Respondents who defined themselves as regular users
and had used the product at least one time in the past
week met the minimum usage requirement. Subjects
affiliated with related industries including market re-
search, advertising, sales promotions, public relations,
fragrance, cosmetics, or toiletries, mail order or door-
to-door sales were disqualified, as was anyone partici-
pating in marketing research within the past six months,
or planning to go on vacation, move, or have a baby
during the period of intended usage of products. Sub-
jects needed to be willing to use the product as their
exclusive lipstick, body lotion, or face cream for the en-
tire two week period, and were told not to share the
product with other household members. Subjects were
recruited in three age categories: 18–39; 40–59; and
60–65, with the number of subjects in each age category
weighed as closely as possible to match the age distribu-
tion of women in the US. Qualified respondents were
each assigned to test two of the three product types.
Ten percent of all study respondents were called and
re-qualified (verified) during the product usage stage.
Statistical analysis of the data was conducted by Expo-
nent, Inc. (Washington, DC).
2.2. Test products
Typical cosmetic formulations similar to marketed
products were used for each of the three product types.
Ingredient declarations for each product are listed in
Table 1. In the case of lipstick, study subjects were given
the choice of two color shades, a ‘‘pink/brown’’ shade or
a ‘‘yellow/brown’’ shade. The lipstick formulations were
identical other than the color ingredients. Single formu-
lations were used for body lotion and face cream. The
products were packaged in plain containers, each with
a sticker attached bearing a unique identification num-
ber. Pre- and post-weighing for all test products was
conducted using a scale that measured at milligram
sensitivity.
2.3. Diaries
Each subject was given two of the test products for
normal ‘‘real world’’ usage at home for two weeks,
and was asked to record daily information on their use
of each test product in a diary that was provided to
them. Information collected for all products was:
whether the product was used that day; total number
of applications for that day; and time of application(s).
For lipstick, subjects were asked to designate the type of
application (‘‘full application’’, ‘‘touch up’’, or ‘‘removal
followed by re-application’’). For body lotion, subjects
were asked to identify the area(s) of application (hands,
 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291 281

Table 1
Listing of ingredients
Face cream: Water, cyclopentasiloxane, glycerin, mineral oil, stearic acid, myristyl myristate, vegetable oil, octyl methoxycinnamate, beeswax,
glyceryl stearate, octyl palmitate, PEG-100 stearate, phenylbenzimidazole sulfonic acid, soybean protein, sesame oil, C13-14 isoparaffin, cetyl
alcohol, stearyl alcohol, fragrance, diazolidinyl urea, methylparaben, acrylates copolymer, tocopheryl acetate, pea extract, laureth-7, butylparaben,
disodium EDTA, chlorphenesin, sodium dehydroacetate
Body lotion: Purified water, glycerin, emulsifying wax NF, octyl isononanoate, dimethicone, propylene glycol isoceteth-3 acetate, cyclomethicone,
stearic acid, aloe extract, matricaria extract, tocopheryl acetate, dimethicone copolyol, acrylates/C10-30 alkyl acrylate crosspolymer, cetearyl alcohol,
sodium cetearyl alcohol, sodium sulfate, hydrogenated lanolin, glyceryl laurate, tetrasodium EDTA, triethanolamine, BHT, dipropylene glycol,
propylene glycol, methylparaben, ethylparaben, propylparaben, diazolidinyl urea, benzalkonium chloride, fragrance
Lipstick: Castor (Ricinus communis) oil, cetyl acetate, caprylic/capric triglyceride, candelilla (Euphorbia cerifera) wax, sterol esters, octyl palmitate,
PVP/hexadecene copolymer, lanolin wax, ozokerite, PEG-4 diheptanoate, polyglyceryl-3 diisostearate, beeswax, carnauba (Copernica cerifera) wax,
phenyl trimethicone, acetylated lanolin alcohol, Di-C12-15 alkyl fumarate, octyl methoxycinnamate, trioctyldodecyl citrate, acrylates copolymer,
jojoba (Buxus chinensis) oil, organopolysiloxane, diisopropyl dimer dilinoleate, isopropyl isostearate, fragrance, polyoxymethyleneurea, BHT,
tocopheryl acetate, silica
May contain: barium sulfate, mica, titanium dioxide, iron oxides, D&C Red No. 7 Calcium Lake, Carmine, D&C Red No. 21, D&C Red No. 6
Barium Lake, FD&C Yellow No. 6 Aluminum Lake, D&C Red No. 27 Aluminum Lake, D&C Red No. 21 Aluminum Lake, FD&C Yellow No. 5
Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, Manganese Violet, Tin Oxide, D&C Red No. 33 Aluminum Lake

arms, feet, legs, face, neck/throat, back, torso, other).
For all products, subjects were asked where they spent
most of their time during that day, in order to encourage
daily diary entries.
At the end of the two week period, subjects were
asked to compare their regular product usage with that
of the test product in terms of frequency of use (more
often, as often, less often) and product rating (better,
same, worse). Subjects were also given free text space
to enter comments about the product.
2.4. Data collection, data entry, and data checking
Respondents returned the test products and the com-
pleted diaries after two weeks of usage. The diaries were
reviewed and checked to ensure they were filled out
accurately and completely. Diaries that were not filled
out correctly or completely were deleted when appropri-
ate. For example, respondents that only completed the
diary for a few days, or those who did not answer the
comparison questions at the end were eliminated.
The respondentsÕ data were then entered and linked to
the pre- and post-weight data files.
3. Results
3.1. Completion rate
Of the 360 subjects recruited per product, 86.4%,
83.3%, and 85.6% completed the study and returned
valid diaries for lipstick, body lotion and face cream,
respectively.
3.2. Characteristics of the study population and
association with use patterns
The age distribution of the study population was
compared with that of the adult female population in
the US. A larger proportion of the study subjects be-
longed to the oldest age group (60–65 years) as com-
pared to the US female population aged 18–65 years.
However, when that proportion was compared to the
proportion of the female US population that is 60 years
or older, no statistically significant difference [Chi-
square test (Colton, 1974) with two-degrees of freedom 3
and a 5% significance level] was observed. The range of
age distributions for study subjects using the three prod-
ucts is presented in Table 2; distributions for subjects
using each product type were comparable.
The geographical distribution of the study population
was compared to the distribution of the US female pop-
ulation. The ten cities were grouped into four regions
according to the US Census (Northeast, South, Mid-
west, and West). A statistically significant difference is
observed between the two distributions, with the North-
east and South regions underrepresented in the study,
and the Midwest and West overrepresented (Chi-square
test with three degrees of freedom 4 and a 5% signifi-
cance level). However, this difference is not likely to af-
fect the representativeness of the study since there were
no significant differences between the women in the four
regions regarding the use or rating of the products (dis-
cussed below). The distribution was comparable for sub-
jects using each of the three product types. Table 3
shows the range of distributions for study subjects using
the three products.
The three age groups were compared with respect to
their rating of the test product. For all products, at least
50% of respondents in all age groups reported liking the
3
Chi-square test comparing the number of participants in each age
group to the numbers that would be expected if the age distribution in
the Census applied to the survey participants.
4
Chi-square test comparing the number of participants in each
region to the numbers that would be expected if the regional
distribution in the Census applied to the survey participants.
282 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291

Table 2
Age distribution of the study population
Age distribution (years) Survey Census (numbers in thousands)
Women 18–65 years All adult women
Numbera Percent Number Percent Number Percent
18–39 111–118 36–38 39,014 47 39,014 38
40–59 121–133 40–43 37,619 46 37,619 37
60–65 65–68 22 5658 7 26,039b 25
Total 300–311 100 82,291 100 102,672 100
a
Ranges represent low and high numbers of subjects for the three different products.
b
Includes women older than 65.

Table 3 significance level) between the different age groups

Geographical distribution of the study population (Table 4).
Region Survey Census The groups were compared with respect to their rat-
Numbera Percent Percent ing of the test product versus their regular product
NE 35–40 12–13 19 and relative use patterns. For face cream and body lo-
MW 92–95 30–32 23 tion, 46% and 50% of respondents, respectively, re-
S 84–93 28–30 36 ported liking the test product better than their regular
W 84–91 27–29 22 product, while for lipstick, 43% rated the test lipstick
Total 300–311 100 100 the same as their regular product while 24% rated it bet-
a
Ranges represent low and high numbers of subjects for the three ter. For all products, the majority of women in each age
different products. group reported using the test product at least as often as
their regular product. There were no statistically signif-
icant differences (Chi-square test with four degrees of
product. The percentage reporting they liked the prod- freedom and a 5% significance level) between the three
uct ranged from a low of 50% (lipstick, 18–39 years) age groups with respect to their rating or the use fre-
to a high of 82% (body lotion, 40–59 years). While the quency of any of the test products. Results for each
percentage of respondents reporting they disliked the product type are shown in Fig. 1A–C.
product was generally higher among the younger Subjects in the four geographical regions were ana-
women, there were no statistically significant differences lyzed with respect to their rating of the test product
(Chi-square test with four degrees of freedom and a 5% and use patterns. The four regions had similar responses

Table 4
Rating of test product by age group—(A) lipstick, (B) body lotion, and (C) face cream
Age group
18–39 years 40–59 years 60–65 years Total
Number Percent Number Percent Number Percent Number Percent
(A) Rating of test lipstick
Disliked lipstick 33 30 32 24 9 15 74 24
Neutral 23 21 22 17 14 23 59 19
Liked lipstick 55 50 77 59 39 63 171 56
Total 111 100 131 100 62 100 304 100

(B) Rating of test lotion

Disliked lotion 20 17 12 10 4 6 36 12
Neutral 17 15 10 8 10 15 37 12
Liked lotion 80 68 100 82 54 79 234 76
Total 117 100 122 100 68 100 307 100

(C) Rating of test face cream

Disliked face cream 15 13 16 14 5 8 36 12
Neutral 15 13 14 12 14 22 43 15
Liked face cream 84 74 88 75 45 70 217 73
Total 114 100 118 100 64 100 296 100
 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291
Fig. 1. Rating and use of test product versus regular product by age group—(A) lipstick, (B) body lotion, and (C) face cream.
(Chi-square test with six degrees of freedom and a 5%
significance level) to the test products with a majority
of participants in each region reporting that they liked
the test product (Table 5A–C). Note however, that the
relatively small number of participants in some cells
(e.g., Northeast region) may have limited the power of
the statistical tests to detect a significant difference. Sub-
jects in the different regions were also analyzed with re-
spect to their use of the test products. As with the
different age groups, the majority of the women in each
region reported using each of the products at least as
often as their regular product. For face cream and body
lotion, the highest proportion of respondents in all re-
gions reported that they liked the test product better
than their regular product (percentage ranges of 40–
53% for face cream and 44–57% for body lotion across
the regions). For lipstick, the percentage reporting that
they liked the test lipstick the same as their regular prod-
uct was similar across regions (range of 41–45%). There
were no statistically significant differences (Chi-square
test with six degrees of freedom and a 5% significance
level) between the four regions with respect to their
283
rating or use of any of the test products (data not
shown). Again, the relatively small number of partici-
pants in some cells (e.g., Northeast region) may have
limited the power of the statistical tests to detect a signif-
icant difference.
3.3. Frequency of use distributions
3.3.1. Daily use rates
The proportion of women using each of the products
declined over the survey duration for all three products.
The percentage of subjects using product on day 1 was
99.0%, 99.7%, and 99.0% for lipstick, body lotion, and
face cream, respectively, and declined to 73.5%, 76.0%,
and 79.0% by day 14. The decline was most pronounced
for participants reporting that they disliked the test
product (Fig. 2A–C). It is not clear if the decline in
the use rate among the women reporting that they liked
the test product reflects a higher than usual use rate
in the early part of the survey followed by a leveling
of the use rate in the later part of the survey to what
their normal use rate would have been. The probability
284 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291

of using product on any day was derived from pooling

the 14 days data and assuming they represent indepen-
dent observations. The probability was 86.2%, 89.6%,
and 91.6% for lipstick, body lotion, and face cream,
respectively.

3.3.2. Number of applications per day

The number of applications per day varied depending
on product type. For lipstick, the number ranged from 0
applications per day to 20, with about 78% of the
respondents reporting 3 or less applications per day.
For body lotion, the number of applications per day
ranged from 0 to 28, with about 80% of respondents
reporting 3 or less applications per day. For face cream,
the number ranged from 0 applications per day to 11,
with about 86% of the respondents reporting 2 or less
applications per day. Fig. 3A–C summarizes the distri-
bution of the number of applications per day for each
day of the survey for the three products. Table 6A–C
summarizes the average number of applications per sur-
vey day for each product. The ‘‘total survey’’ estimates
were derived by assuming that the 14 person days con-
tributed by each of the participants represented indepen-
dent person-days of observations. Thus, for instance, in
the case of lipstick, the ‘‘total survey’’ estimates are
based on 4354 person days (14 person days for each of
the 311 participants).

3.3.3. Amount applied

The amount of product used during the survey was
derived as the difference between the weight of the con-
Fig. 1 (continued) tainer before, and its weight after the survey. No direct

Table 5
Rating of test product by geographical region—(A) lipstick, (B) body lotion, and (C) face cream
Region
North East South Midwest West Total
Number Percent Number Percent Number Percent Number Percent Number Percent
(A) Rating of test lipstick
Disliked lipstick 9 23 21 23 25 27 19 24 74 24
Neutral 7 18 22 24 16 17 14 18 59 19
Liked lipstick 24 60 49 53 52 56 46 58 171 56
Total 40 100 92 100 93 100 79 100 304 100

(B) Rating of test lotion

Disliked lotion 3 8 13 15 9 10 11 12 36 12
Neutral 3 8 14 16 10 11 10 11 37 12
Liked lotion 31 84 60 69 72 79 71 77 234 76
Total 37 100 87 100 91 100 92 100 307 100

(C) Rating of test face cream

Disliked cream 1 3 11 13 17 18 7 8 36 12
Neutral 5 14 11 13 16 17 11 13 43 15
Liked cream 29 83 61 73 62 65 65 78 217 73
Total 35 100 83 100 95 100 83 100 296 100
 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291 285

1.1 1.1

Proportion (SE) Using The Lotion On Given Day

Proportion (SE) Using the Lipstick on Given Day

1.0
1.0

.9
.9

.8

.8

.7
Lipstick Rating Lotion rating
.7

.6
Disliked Lipstick Disliked Lotion

.6
Neutral .5
Neutral

.5
Liked Lipstick .4
1 2 3 4 5 6 7 8 9 10 11 12 13 14 Liked Lotion
1 2 3 4 5 6 7 8 9 10 11 12 13 14
Day
(A) (B) DAY

1.1
Proportion (SE) using The Face Cream On Given Day

1.0

.9

.8

.7
Face Cream rating

.6
Disliked Face Cream

.5
Neutral

.4
Liked Face Cream
1 2 3 4 5 6 7 8 9 10 11 12 13 14

(C) Day

Fig. 2. Rating and use of test product—(A) lipstick, (B) body lotion, and (C) face cream.

information was available on the actual amount used 3.3.4. Analyses of usage patterns based on product
per day. For each study participant, the ratio of the preference
amount used to the number of use days was used to esti- To further evaluate the effect of having subjects use
mate the average amount of product used per day, while model formulations in place of their normal brand of
the ratio of the total amount used to the total number of product, additional analyses were undertaken to evalu-
applications for the entire survey was used to estimate ate the effect that the subjectsÕ relative like/dislike of
the average amount of product used per application. the product had on their use patterns. For each of the
Table 7A–C summarizes the distribution of the total three products, three sets of subgroups were analyzed.
amount of each product used during the survey, the The subgroups consisted of those women that reported:
average amount of each product used per day, and the (1) disliking, liking, or neutral for the test product; (2)
average amount of each product used per application. the test product worse, the same, or better than their
The standard deviation estimates presented in these ta- regular product; and (3) used test product less often,
bles for the average amount of each product used per as often, or more often that their regular lipstick. Each
day, and the average amount of each product used per subgroup was analyzed independently to determine
application do not take into account the fact that these differences in use patterns within the three groups.
two variables are, in fact, derived as ratios of two ran- Results of the worse/same/better stratified groups are
dom variables, and thus the estimates of the standard shown in Table 8. While the number of days used tended
deviations are not adjusted for the potential covariance to be less for the subgroup that rated the product worse
between these two variables. than their regular product, the average use per day was
286 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291
Fig. 3. Number of applications of test product for each survey day—(A) lipstick (N = 311), (B) body lotion (N = 308), and (C) face cream (N = 300).
highest in the ÔworseÕ subgroup for two of the three
products (lipstick and face cream), and was the same
in the ÔworseÕ and ÔbetterÕ subgroups for the third prod-
uct (body lotion). There was no clear correlation be-
tween the average number of applications per use day
and rating of the product. Similar results were obtained
in the other stratified groups (liked product/neutral/dis-
liked product; and used less frequently than regular
product/same/used more frequently than regular prod-
uct) (data not shown).
3.3.5. Type of application—lipstick
Survey participants indicated for each lipstick appli-
cation whether it was a full application, a ‘‘touch-up’’,
or a complete removal followed by re-application. The
great majority of women (99.4%) made a full lipstick
application for their first application. For the second
through fifth application, the most common application
was a ‘‘touch-up’’ (47.7–53.7%), while the percentage of
‘‘full’’ applications ranged from 39.0 to 43.7%, and re-
moval followed by re-application accounted for 4.4–
10.4%. The sixth application again showed a majority
of women (55.5%) made a full lipstick application. The
data are summarized in Table 9.
3.3.6. Number of applications per body area—body lotion
For each reported application of body lotion
throughout the 14-day period, survey subjects recorded
the area(s) of the body on which the lotion was applied
(up to six applications per day). Fig. 4 summarizes the
number of reported applications for each body area.
The body area on which the lotion was most frequently
applied was hands, followed by arms, and followed by
legs and feet.
4. Discussion
The present study was designed to generate exposure
data on cosmetic use practices that can be used for risk
Table 6
Number of applications per day
(A) Number of applications per day—lipstick (N = 311)
Day Applications/day
Mean Median S.D.
1 2.59 2 2.14
2 2.82 3 1.76
3 2.68 3 1.79
4 2.64 2 1.87

L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291

5 2.64 2 1.86
6 2.51 2 1.78
7 2.32 2 1.70
8 2.32 2 1.73
9 2.10 2 1.72
10 2.26 2 1.72
11 2.06 2 1.66
12 2.17 2 1.82
13 2.04 2 1.74
14 1.80 1 1.62
Total surveya 2.35 2 1.80
b
(B) Number of applications per body area per day —body lotion (N = 308)
Day Hands Arms Feet Legs Neck & Throat Back Other Body Areasc
Mean Median S.D. Mean Median S.D. Mean Median S.D. Mean Median S.D. Mean Median S.D. Mean Median S.D. Mean Median S.D.
1 2.08 2 1.34 1.60 1 1.19 0.98 1 1.05 1.14 1 1.06 0.44 0 0.89 0.28 0 0.70 0.40 0 0.82
2 2.45 2 1.50 1.85 2 1.30 1.13 1 1.15 1.28 1 1.06 0.51 0 0.90 0.31 0 0.74 0.49 0 0.89
3 2.26 2 1.50 1.72 1 1.32 1.07 1 1.13 1.27 1 1.09 0.52 0 0.92 0.33 0 0.78 0.46 0 0.79
4 2.26 2 1.55 1.63 1 1.26 1.04 1 1.03 1.21 1 0.94 0.47 0 0.83 0.26 0 0.61 0.46 0 0.80
5 2.29 2 1.57 1.61 1 1.31 1.03 1 1.03 1.17 1 1.01 0.51 0 0.89 0.25 0 0.60 0.43 0 0.76
6 2.26 2 1.65 1.57 1 1.33 0.95 1 0.97 1.12 1 0.93 0.48 0 0.90 0.25 0 0.56 0.42 0 0.80
7 2.27 2 1.64 1.60 1 1.28 1.01 1 0.98 1.16 1 0.96 0.44 0 0.84 0.25 0 0.60 0.43 0 0.81
8 2.19 2 1.63 1.55 1 1.33 1.00 1 1.04 1.12 1 0.99 0.44 0 0.81 0.23 0 0.61 0.38 0 0.74
9 2.10 2 1.57 1.51 1 1.27 0.93 1 0.93 1.14 1 0.91 0.39 0 0.75 0.29 0 0.68 0.38 0 0.71
10 2.10 2 1.61 1.47 1 1.32 0.94 1 0.98 1.10 1 0.98 0.39 0 0.74 0.23 0 0.58 0.42 0 0.78
11 1.93 2 1.58 1.37 1 1.28 0.89 1 0.96 1.03 1 0.94 0.35 0 0.74 0.24 0 0.61 0.34 0 0.68
12 1.90 2 1.62 1.27 1 1.24 0.80 1 0.91 0.97 1 0.91 0.34 0 0.69 0.20 0 0.54 0.33 0 0.68
13 1.81 2 1.58 1.27 1 1.27 0.81 1 0.91 0.98 1 0.95 0.40 0 0.82 0.22 0 0.61 0.35 0 0.73
14 1.77 1 1.69 1.23 1 1.33 0.78 1 0.99 0.88 1 0.96 0.34 0 0.71 0.22 0 0.56 0.33 0 0.65
Total surveyd 2.12 2 1.59 1.52 1 1.30 0.95 1 1.01 1.11 1 0.98 0.43 0 0.82 0.26 0 0.63 0.40 0 0.76

287
 288
Table 6 (continued)
(C) Number of applications per day—face cream (N = 300)

L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291

Applications/day
Mean Median S.D.
1 1.65 1 0.99
2 1.96 2 1.09
3 1.88 2 1.15
4 1.89 2 1.11
5 1.89 2 1.14
6 1.86 2 1.09
7 1.81 2 1.06
8 1.80 2 1.21
9 1.81 2 1.19
10 1.75 2 1.18
11 1.69 2 1.19
12 1.68 2 1.29
13 1.60 2 1.20
14 1.47 1 1.30
Total surveye 1.77 2 1.16
a
Total survey estimates were derived by assuming that the 14 person days contributed by each of the participants represented independent person-days of observations. Thus, in the case of
lipstick, the estimates are based on 4354 person days (14 person days for each of the 311 participants).
b
Data collected on use on specific body areas was restricted to up to 6 body areas per day.
c
‘‘Other Areas’’ included torso, face, hips, buttocks, and elbows.
d
Total survey estimates were derived by assuming that the 14 person days contributed by each of the participants represented independent person-days of observations. Thus, in the case of body
lotion the estimates are based on 4312 person days (14 person days for each of the 308 participants).
e
Total survey estimates were derived by assuming that the 14 person days contributed by each of the participants represented independent person-days of observations. Thus, in the case of face
cream the estimates are based on 4200 person days (14 person days for each of the 300 participants).
 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291 289

Table 7
Amount of test product used (grams)
Summary statistics Total amount applied Averagea amount applied per use day Averageb amount applied
per application
(A) Amount of test product used (grams)—lipstick
Minimum 0.001 0.000 0.000
Maximum 2.666 0.214 0.214
Mean 0.272 0.024 0.010
S.D. 0.408 0.034 0.018
Percentiles
10th 0.026 0.003 0.001
20th 0.063 0.005 0.003
30th 0.082 0.008 0.004
40th 0.110 0.010 0.004
50th 0.147 0.013 0.005
60th 0.186 0.016 0.006
70th 0.242 0.021 0.009
80th 0.326 0.029 0.011
90th 0.655 0.055 0.024
95th 0.986 0.087 0.037
99th 2.427 0.191 0.089
Best fit distributions & parametersc Lognormal distribution Lognormal distribution Lognormal distribution
Geometric mean 0.14 Geometric mean 0.01 Geometric mean 0.01
Geometric S.D. 3.56 Geometric S.D. 3.45 Geometric S.D. 3.29
P-value (Gof) = 0.01 P-value (Gof) < 0.01 P-value (Gof) < 0.01

(B) Amount of test product used (grams)—body lotion

Minimum 0.67 0.05 0.05
Maximum 217.66 36.31 36.31
Mean 103.21 8.69 4.42
S.D. 53.40 5.09 4.19
Percentiles
10th 36.74 3.33 1.30
20th 51.99 4.68 1.73
30th 68.43 5.71 2.32
40th 82.75 6.74 2.76
50th 96.41 7.63 3.45
60th 110.85 9.25 4.22
70th 134.20 10.90 4.93
80th 160.26 12.36 6.14
90th 182.67 14.39 8.05
95th 190.13 16.83 10.22
99th 208.50 27.91 27.71
Best fit distributions & parameters Beta distributionc Gamma distribution Lognormal distribution
Alpha = 1.53 Location = 0.86 Geometric Mean = 3.26
Beta = 1.77 Scale = 2.53 Geometric S.D. = 2.25
Scale = 222.01 Shape = 3.77
P-value (GoF) = 0.06 P-value (GoF) = 0.37 P-value (GoF) = 0.63

(C) Amount of test product used (grams)—face cream

Minimum 0.04 0.00 0.00
Maximum 55.85 42.01 21.01
Mean 22.36 2.05 1.22
S.D. 14.01 2.90 1.76
Percentiles
10th 5.75 0.47 0.28
20th 9.35 0.70 0.40
30th 12.83 1.03 0.53
40th 16.15 1.26 0.67
50th 19.86 1.53 0.84
60th 23.79 1.88 1.04
70th 29.31 2.23 1.22
80th 36.12 2.90 1.55
90th 44.58 3.50 2.11
(continued on next page)
290 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291

Table 7 (continued)
Summary statistics Total amount applied Averagea amount applied Averageb amount applied
per use day per application
95th 48.89 3.99 2.97
99th 51.29 12.54 10.44
Best fit distributions & parameters Triangle distribution Lognormal distributionc Lognormal distributionc
Minimum 1.09 Geometric Mean 1.39 Geometric Mean 0.80
Maximum 58.71 Geometric S.D. 2.58 Geometric S.D. 2.55
Likeliest 7.53
P-value (GoF) = 0.27 P-value (GoF) < 0.01 P-value (GoF) = 0.02
a
Derived as the ratio of the total amount used to the number of use days.
b
Derived as the ratio of the total amount used to the total number of applications during the survey.
c
None of the tested distributions provided a good fit.

Table 8
Summary of use patterns based on the respondentsÕ reported rating of the test product compared to their regular product
Rating Lipstick Face cream Body lotion
group
# of # of Average # Average # of # of Average # of Average # of # of Average # of Average
subjects days of applications use subjects days applications use per subjects days applications use per
used per use day per day used per use day day (g) used per use day (g)
(S.D.) (S.D.) (g) (S.D.) (S.D.) (S.D.) (S.D.) (S.D.) day (S.D.) (S.D.)
Worse 99 11.1 2.8 0.026 59 11.6 1.7 2.2 64 11.4 2.1 8.8
(3.8) (1.6) (0.035) (3.7) (0.6) (2.7) (4.2) (1.2) (6.8)
Same 133 12.4 2.5 0.022 99 12.8 1.7 1.7 88 12.4 2.5 8.2
(2.7) (1.3) (0.034) (2.6) (0.7) (1.5) (2.9) (1.5) (5.0)
Better 74 12.8 2.9 0.021 137 13.5 2.1 1.9 154 13.1 2.8 8.8
(2.3) (1.5) (0.032) (1.3) (1.2) (1.2) (1.5) (1.5) (4.2)
All 306 12.1 2.7 0.024 295 12.8 1.9 2.05 306 12.5 2.5 8.7
rating (3.1) (1.5) (0.034) (2.6) (1.0) (2.9) (2.8) (1.5) (5.1)
groups

Table 9 three products. Analyses of variability in use practices

Type of lipstick applicationa by individual participants, that is analyses of trends, if
Application Full Touch-up Removal/ any, in the individual use profiles, were not conducted.
order (%) (%) re-application (%) Variability in amounts used by different subjects was,
1st 99.4 0.6 0.1 not unexpectedly, quite high. This is consistent with
2nd 43.7 52.0 4.4 other published and unpublished data on cosmetic and
3rd 41.9 47.7 10.4
4th 40.8 49.8 9.4
personal care product use (Weegels and van Veen,
5th 39.0 53.7 7.3 2001; EPA, 1997).
6th 55.2 41.9 3.0 It is not clear if the very high end users of product
a
Derived using the pooled data from all 14 days. represented true usage, or whether other explanations
may have applied. Given the study design, in which sub-
jects used the product in their homes and the overall
assessment purposes. Three widely used products, lip- amount used was determined after two weeks usage, it
stick, body lotion, and face cream, were included in cannot be ruled out that product may have been spilled,
the study. While many cosmetic products are rinsed off or that others in the household may have used the prod-
shortly after application, the products chosen for this uct, despite instructions to the contrary. Likewise, low
study are all ‘‘leave-on’’ products, resulting in greater end use could either reflect real practices, or could reflect
opportunity for absorption from the skin, and in the dislike of the product, thus resulting in underestimation
case of lipstick, for oral ingestion. One of the products, of real world use.
body lotion, can be applied over much of the surface Based on expert industry opinion, the test prototype
area of the body, with potential for much greater expo- formulations used in the study represent typical prod-
sure than most cosmetic products. The analyses pre- ucts currently sold in-market. The advantage of using
sented in this paper are intended to provide summary prototype formulations is easier interpretation of the
statistics on usage patterns and amounts used for these data by eliminating the product as a variable, and sim-
 L.J. Loretz et al. / Food and Chemical Toxicology 43 (2005) 279–291
100
NUMBER OF REPORTED USES
80
60
40
20
0 ter’’ subgroups for the third product. There was no clear
HANDS
ARMS
LEGS
NECK&THROAT
FEET
BACK
OTHER
Fig. 4. Total reported number of body lotion uses per body area. The
‘‘boxes’’ represent the range between the 1st and 3rd quartiles and
include the middle 50% of the observations. The horizontal line inside
the box represents the median. The ‘‘whiskers’’ extend from the boxes
to the end to the farthest points that are not outliers. Observations that
are outside the range defined by the quartiles ± 1.5 · interquartile
range are considered outliers. The interquartile range is the difference
between the 75th percentile and the 25th percentile. Outliers are
represented by ‘‘o’’ (if they are further outside, i.e., if they are outside
the quartiles ± 1.5 · interquartile range) or ‘‘H’’ (if they are further
outside, i.e., if they are outside the quartiles ±3 · interquartile range).
plification of the study design and execution. The disad-
vantage is that real world variation may be lost, and use
practices may be affected.
To address the latter point, respondents were asked
to rate the product in an absolute sense (liked, neutral,
disliked) and relative to the product they usually use
(better, same, worse). Percentages of respondents
reporting that they either liked or were neutral to the
product were 71%, 83%, and 87% for lipstick, body lo-
tion, and face cream, respectively. Products were rated
the same or better than the subjectsÕ regular product
by 67%, 79%, and 80%. Study subjects were also asked
to compare product usage during the study with their
usual practices. The percentages reporting using product
as often as their regular product were 61%, 58%, and
68% for lipstick, body lotion, and face cream, respec-
tively. The percentage of subjects who reported using
the test product more often than their usual product
was higher than the percentage using the test product
less often for body lotion and face cream (15% and
13% less often, 27% and 19% more often for body lotion
and face cream, respectively), but was slightly lower for
lipstick (23% and 16% reporting less often and more
often, respectively).
To further examine whether subjectsÕ like or dislike of
the product affected use practices, additional analyses
were undertaken within subgroups of test subjects. The
subgroups analyzed were based on rating of the test
product (disliked, neutral, liked); comparison of the test
291
product to regular product (worse, same, better), and
comparison of usage of the test product to regular usage
(less often, regular, or more often). Endpoints evaluated
were average number of days used, average number of
applications made per use day, and average amount
used per day. While subjects who reported liking the
product less tended to use the product for fewer days,
the average amount used per day was highest in the
groups liking the product the least for two of the three
products, and was the same for the ‘‘worse’’ and ‘‘bet-
correlation between the average number of applications
per use day and rating of the product. Therefore it is
concluded that the normal variation in use practices
was greater than differences that result from the subjectsÕ
like or dislike of the product. This supports the validity
of the data, and the general validity of developing expo-
sure data using model formulations in place of specific
brands of product.
The study was carried out in 10 cities, in order to as-
sess regional variation, which could be due to factors
such as weather, or could reflect cultural differences in
the use of these products. No significant differences were
seen in product usage across the different regions of the
country. However, the relatively small number of partic-
ipants in some cells (specifically the number of subjects
from the Northeast region) may have limited the power
of this study to detect significant differences between
regions (if any).
The data reported here provide current usage informa-
tion for three widely used cosmetic product types for
which reliable data was not previously readily available.
These data provide a starting point for cosmetic safety
assessment. In order to evaluate specific ingredients,
information on their concentration in a product, and on
dermal penetration, will be useful to refine exposure
assessments. Additional studies to evaluate exposure
levels for other product types are currently underway.
References
Bergfeld, W.F., Andersen, F.A., 2000. The cosmetic ingredient review.
In: Estrin, N., Akerson, J. (Eds.), Cosmetic Regulation in a
Competitive Environment. Marcel Dekker, Inc., New York, pp.
195–216.
Colton, T., 1974. Statistics in Medicine. Little, Brown and Co.,
Massachusetts.
European Centre for Ecotoxicology and Toxicology of Chemicals
[ECETOC], 1993. Monograph No. 20. Percutaneous Absorption.
US Environmental Protection Agency, 1997. Consumer products. In:
Exposure Factors Handbook, vol. III, pp. 16.1–16.40, Washington,
DC 20460.
Weegels, M.E., van Veen, M.P., 2001. Variation of consumer contact
with household products: a preliminary investigation. Risk Anal-
ysis 21, 499–511.