Note: Descriptions are shown in the official language in which they were submitted.
B15a
--1--
SUNBLOCK FORMULATIONS
Ultraviolet energy absorbed by the human
skin can produce an erythemal reaction (redness).
The intensity of the reaction is dependent upon
the amount of energy absorbed. Ultraviolet
radiation from both sunlight and artificial sources
has been divided into three bands (UV-A, UV-B,
and UV-C) which emit different quantities of
energy and therefore produce an erythemal
reaction at different time intervals after
exposure. The amount of energy from any source
required to produce a minimally perceptible
redness reaction of the skin is termed the
Minimal Erythema Dose or MED.
UV-A radiation is present in the sunlight
reaching the earth's surface and has a wavelength
of 320 to 400 nanometers (nm.). It can cause
tanning of the skin but is weak in causing
reddening of the skin. About 20 to about
50 joules/cm of UV-A energy is required to
produce one MED. The erythema reaction is
maximal in intensity about 72 hours after
exposure.
UV-B radiation is present in the sunlight
reaching the earth's surface and has a ~ave-
length of 290 to 320 nm. It causes the
sunburn reaction which also stimulates
piymentation (tanning) in the skin.
Approximately 20 to S0 millijoules/cm of
UV-B energy is required to produce one MED
(i.e., about 1,000 times less than the dose
of UV-A). The erythema reaction is maximal
in intensity at from about 6 to about 20
hours after exposure.
,, ~
B15a
UV-C radiation has a wavelength of 200 to 290 nm.
and is not present in the sunlight reaching the earth's
surface but can be emitted by artificial ultraviolet
sources. It is not effective in stiumulating pigmenta-
tion but does cause erythema requiring about 5 to 20millijoules/cm to produce one MED.
The tanning ability of an individual is geneti-
cally predetermined and is governed by the individual's
capacity to produce melanin pigment within the pigment
cells when stimulated by UV-B and UV-A. The
extent of any erythemal response is a function of s~in
color and thus less time is required to produce a MED
in light skinned individuals tha~ to produce a MED in
dark skinned individuals.
The most rapid way to cause tanning is to allow
the sun to produce erythema of the skin. Erythema suf-
ficient to induce tanning yet not so severe as to cause
pain requires only half the time of exposure that is
required to produce a pain~ul sunburn. Suntanning can
occur at the UV-A wavelengths but develops slowly under
natural conditions. Tanning most commonly develops
after exposure to the "sunburn" UV-B band.
Sunscreen preparations are commercially avail-
a~le which extend the time it takes the sun to produce
a sunburn. Such preparations contain chemicals which
can absorb ultraviolet light at various wavelengths,
i.e. 2-hydroxy-4-methoxybenzophenone which absorbs UV-A,
or an opaque substance that phsically re~lects or scat-
ters the ultraviolet light, i.e. talc.
~ltraviolet absorbing compounds and sunscreen
compositions containing the same are disclosed, for
example, in U. S. Patents 3~004r~96; 3,1B9,615; 3,403,207;
3,479,428; 3,644,614; 3,670,074; 3,751,563; 3,821,363;
3,892,844; British Patent 1~291,917; etc.
,
~ 2~
B15a
--3--
Since sunscreen products are often employed by
people undergoing physical exertion particularly in
warm climates or people who are engaging in water activ-
ities, it is desirable to have a product which is moisture
resistant. Attempts at formulating such products have
included the development of polymeric ultraviolet absor-
bing compounds and compositions, as note, U. S. Patents
3,666,732; 3,795,733; 3,864,473; 3,895;104; 3,980,617;
4,004,047; etc.
This invention is directed to sun block or
sunscreen formulations having enhanced ultraviolet
absorbing properties. The formulation is preferably
a water in oil emulsion which contains water, emollients,
emulsifiers, preservatives, antioxidants, and one or
more known ultraviolet absorbing compounds. The ultra-
violet absorbing property of the formulation is enhanced
by including from about 2.0% to about 15~ by weight of
polyethylene, preferably from about 2.5% to about 6.0%
by weight of low density, low molecular weight poly-
ethylene homopolymer.
This invention is directed to a sunblock or
sunscreen formulation having enhanced ultraviolet absorb-
tion in both the sunburning (UV-B) and tanning (UV-A)
regions. The formulation contains one or more known
ultraviolet absorbing compounds and from about 2.0~
3~ to about 15% by weight of polyethylene. Various other
ingredients such as emollients,emulsifiers, preservatives,
antioxidants, fragrances, coloring agents~ etc. can be
included within the formulation.
The formulation is preferably a water in oil
B15a
type emulsion since this affords added moisture resis-
tance to the product. However, the product could also
be formulated as an oil in water emulsion, cream base,
or oil base. Depending upon the choice of ingredients,
5 the formulation has a semi-solid cream like consistency
which can be packaged in a plastic squeeze tube or it
has a lotion type consistency which can be packaged in
a plastic squeeze container. The container can include
a flow type cap or pump type dispenser.
The formulation contains one or more known ultra-
violet absorbing agents, preferably at least one com-
pound which absorbs in the UV-B region and at least one
compound which absorbs in the UV-A region. The total
amount of W absorbing agents included within the formu-
lation will be from about 3% to about 1596 by weight.
Suitably W-A absorbing agents include 2-(2'-
hydroxy-5'-methylphenyl)benzotriazole (Tinuvin P);
2-(2'- hydroxy-5'-_-octylphenyl~benzotriazole (Spectra-
Sorb W 54111; 2,4-dihydroxybenzophenone (Uvinul 400);
20 2-hydroxy-4-methoxybenzophenone (oxybenzone, Spectra-
Sorb W9, Uvinul M-40); 2,2', 4,4'-tetrahydroxybenzo-
phenone (Uvinul D50); 2,2'-dihydroxy-4,4'-dimethoxy-
benzophenone (Uvinul ~ D49); 2,2l-dihydroxy-4-methoxy-
benzophenone (dioxybenzone, Spectra-Sorb UV24); 2-ethyl-
hexyl-4-phenyl-benzophenone carbonate (Eusolex 35733;
2-hydroxy-4-methoxy-~'-methylbenzophenone (mexenone,
Uvistat 221i~, 2-hydroxy-4-(_-octyloxy)benzophenone
(octabenzone, Spectra-Sorb UV531); 4-phenylbenzophenone
(Eusolex 3490); and 2-ethylhexyl-2-cyano-3,3'-diphenyl-
acrylate (Uvinul N539). The UV-A absorbing agent or
agents are present in the final product at ~rom about
0.5% to about 10% by weight o~ the formulation. The
amount will vary according to the
* Trade Mark
'' ' . ' .1
B15a
--5--
particular agent selccted and whether the formulation
is intended to minimizc or permit tanning. The pre-
ferred UV-A absorbing agent is 2-hydroxy-4-methoxy-
benzophenone alone or in combination with 2,2'-dihy-
droxy-4-methoxybenzophenone.
Suitable W -B absorbing agents include 4-(di-
methylamino)benzoic acid, ethyl ester; 4-(dimethyl-
amino)benzoic acid, 2-ethylhexyl ester (Escalol 507);
4-(dimethylamino)benzoic acid, pentyl ester (Escalol
506); glyceryl p-aminobenzoate (Escalol 106); isobutyl
p-aminobenzoate (Cycloform); and isopropyl p-aminoben-
zoate. The W -B absorbing agent or agents are present
in the final product at from about 3% to about 10% by
weight of the formulation. The amount will vary accor-
ding to the particular agent selected and degree of
protection desired in the final product. The prefer-
red UV-B absorbing agent is 4-(dimethylamino)benzoic
acid, 2-ethylhexyl ester.
The critical ingredient in the sun block or
sunscreen formulations is the presence of from about
2.0~ to about 15% by weight of polyethylene, prefer-
ably from about2.5 to about 6% by weight. It has
been found that including ~.0~ by weight or more of
polyethylene results in an enhancement of the UV
absorbin~ properties of the formulation in both the
W -A and W -B regions. Increasing the amount of poly-
ethylene will result in corresponding increased UV
absorbtion up to about 5.5% by weight polyethylene.
Increasing the amount of polyethylene above about
5.5~ does not result in appreciable~increases of W
absorbtion above that found at 5.5%. Thus, the upper
limit of about 15~ by weight polyethylene is based
upon the fact that higher amount will result in an
undesirable product due to the feel and viscosity
of such formulations.
,
* Trade Mark
-- .
B15a
--6--
Suitable forms of polyethylene for inclusion
with~n these sunblock and sunscreen formulations
are,homopolymers having a low molecular weight of
from about 1100 to about 2000 and a low density
of from about 0.88 to about 0.92 g./cc. and
copolymers of polyethylene and vinyl acetate
having a molecular weight of from about 2000 to
about 3500 and a density Gf from about 0.91 to
about 0.93 g./cc. The low molecular weight,
low density polyethylene homopolymers are preferred.
The polyethylene also functions in increasing
the moisture resistance and wash resistance of the
formulation. The polyethylene also aids in
maintaining the stability of the water in oil
emulsion and improves the feel and spreadability
of the formulation.
The formulation also contains from about
40% to about 65% by weight of water, from about
15% to about 30~ by weight of emollients, from
about 3% to about 10~ by weight of emulsifiers,
less than about 1~ by weight of preservatives
and antioxidants, and less than about 1% by weight
of fragrance and coloring agents.
Suitable emollients include mineral oil,
squalane, octyl palmitate, cocoa butter, sesame
oil, pristane, etc. The formulation will preferably
contain a mixture of several of these emollients
or others which are approved for cosmetic use.
Suitable emusifiers include poiyoxyethylene
(3) oleyl ether (Oleth 3), polyglyceryl-4 oleate,
* Trade Mark
~B
.
~l~h~
_7_ B15a
....
I~olysor~ate 80 (~rween 80), etc. Thc formulation
will preferably con~ain a mixturc of two or more
of these emulsifiers or others which are approved
fox cosmetic use.
Suitable preservatives include a methylparaben
(Tegosept M), quaternium-15 (N-(3-chloroallyl)-
hexaminium chloride, ~wicil 200), propylparaben
(Tegosept P), etc., and the preferred antioxidant
is a mixture of butylated hydroxyanisole, propylene
glycol, propyl gallate and citric acid (Tenox 2).
The fo`rmulation will preferably contain the
antioxidant mixture and one or more of the
preservatives or any other preservatives and
antioxidants approved for cosmetic use.
~s discussed above, by varying the
percentage of ingredients the formulation can
be obtained in a lotion or semi-solid form.
For example, in formulation the product as
a lotion, water would be included at fxom
about 60% to 65~ by weight of the final product
and one or more humectants such as propylene
glycol, glycerin, 1,3-butylene glycol, sorbitol,
or sodium pyroglutamate (sodium PCA) could
be inlcuded at up to about 7.5% by weight of
2~ the final product.
~ Trade Mark
~' ' '
t ` -~
.
-~ ~
~: ` : :
,
~,&~
B15a
--8--
The process techniques will vary somewhat
according to the particular ingredients. In
general, the majority of the emollients, emulsi-
fiers, UV-absorbing agents, preservatives, and
antioxidants are blended together with moderate
mixing and heating to a temperature of above
90 C, preferably at from about 92C to about 95 C.
The polyethylene is then added slowly to the
above blend while agitation and heating at above
90C. Preferably, the polyethylene can first
be added slowly with high speed mixing to one of the
emollients which was not included in the main hlend
to completely disperse the polyethylene. This
second blend can then be added slowly to main blend
as with agitating and heating. The mixing is
continued until no undissolved particles of
polyethylene are visible and the oily phase
is maintained at above 90 C.
The water, preferably deionized water,
~0 is heated above 90 C, again preferably from
about 92 to about 95C. Any water soluble
ingredients can be included within this aqueous
phase.
The aqueous phase is then added slowly with
moderate agitation to the oily phase. After the
addition is completed, the agitation is increased
and the mixture is maintained at above 90 C.
until the blend is uniform. The blend is cooled
in several stages to room temperature
with continued agitation, homogenized, and
~8~
B15a
_y_
stored or packaged.
Preferred sunblock formulations offering maxi-
mum pro-tection according to this invention include from
about 50% to about 60~ by weight of water, from about
~.5% to about 6& by weight of a low molecular weight, low density
polyethylene homopolymer, from about 2.5% to about 3.5% by
weight of UV-A absorbing agents selected from 2-hydroxy-
4-methoxybenzophenone (oxybenzone) and 2,2'-dihydroxy-
4-methoxybenzophenone (dioxybenzone), from about 5% to
about 10~ by weight o the W -B absorbing agent 4-(di-
methylamino)benzoic acid, 2-ethylhexyl ester (Escalol
507), from about 20% to about 27% by weight of emol-
lients, from about 4% to about 7% by weight of emul-
sifiers, and up to about 1% by weight of combined pre-
servatives, antioxidants, and fragrances.
Most preferably the maximum protection formula-
tion will contain about 55P6 by weight of deionized water,
about 5.5% by welght of a polyethylene homopolymer having an
average molecular weight of about 2000 and a density of about
0.92 g./cc., about 2.0 to about 2.5% by weight of 2-
hydroxy-4-methoxybenzophenone, up to about 1% by weight
of 2,2'-dihydroxy-4-methoxybenzophenone, about 7% by
weight of 4-(dimethylamino)benzoic acid, 2-ethylhexyl
ester, from about 23% to abcut 25% by weight of emol-
lients, about 5% by weight of emulsifiers, and up to 1%by weight of combined preser~atives, antioxidants, and
fragrances.
Preferred sunscreen formulations which protect
but still permit gradual tanning accoxding to this inven-
tion contain from about 55% to about 65% by weight ofwater, from about 2.5 to about 4.5% by weight of a low den-
sity,low molecular weight polyethylene homopolymer, up to about 1%
by weight of 2-hydroxy-4-methoxybenzophenone (oxybenzone),
from about 3~ to about 5~ by weight of 4-(dimethylamino)-
benzoic acid, 2-ethylhexyl ester (Escalol 507), up to
1315~1
--10--
about 7.5% by weight of humectants, from about 20
to about 25% by weight of emollients, from about 4% to
about 7% by weight of emulsifiers, and up to about 1%
by weight of combined preservatives, antioxidants, and
fragrances.
The most preferred sunscreen formulation which
still permits tanning is a lotion containing from about
60~ to about 61~ by weight of deionized water, about 3.5%
by weight of a polyethylene homopolymer having an average molecu-
lar weight of about 1500 and a density of about O.91g./cc., about 0.6~ by weight of 2-hydroxy-4-methoxybenzo-
phenone,about 3.5% by weight of 4-(dimethylamino)benzoic
acid, 2-ethylhexyl ester, about 5% by weight of glycerin or
propylene glycol, from about 20% to about 22% by weight of e~ol-
15,lients, from about 5% to about 6% by weight of emulsi-
fiers, and up to about l~ by weight of combined preser-
vatives, antioxidants, and fragrances.
The following examples are illustrative of the
invention.
~ B15a
Examples 1 - 4
Sun block formulations having a sun protection
factor (SPF) value greater than 15 are prepared. The
SPF value is determined by dividing the minimal erythema
dose (MED) for protected skin after the application of
2 mg./cm2 of the formulation by the MED for unprotected
skin.
The ingredients are listed on a weight percent
basis and the chemical, CTFA, and/or trade name are
included. All four of these formulations are water in
oil type emulsions in a thick lotion form.
Bl 5a
--12--
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B15a
-14-
The formulations of examples 1 to 4 are prepared
in substantially the same manner. The following is a
detailed description of the preparation of the formula
of Example 3.
3.5 kg. of polyoxyethylene (3) oleyl ether, 1.5
kg. of polyglyceryl-4 oleate, 7 kg. of 4-(dimethylamino)-
benzoic acid, 2-ethylhexyl ester, 2.5 kg. of 2-hydroxy-4-
methoxybenzophenone, 0.5 kg. of 2,2'-dihydroxy-4-methoxy-
benzophenone, 2 kg. of sesame oil, 13.48 kg. of mineral
oil, 0.5 kg. of cocoa butter, 0.02 kg. of Tenox 2, and
0.1 kg. of propylparaben are blended with moderate mixing
and heating at 92 - 95C. The mixing is continued until
the blend is uniform and clear at 92 - 95C.
Meanwhile, 5.5 kg. of polyethylene are slowly
added to 8 kg. of octyl palmitate with high speed mixing
for about 15 minutes until the polyethylene is completely
dispersed.
The polyethylene blend is then slowly added to the
main blend with agitation at a temperature of 92 - 95C.
The mixing is continued until the oily bl~nd is completely
liquid and clear with no undissolved particles of poly-
ethyle visible.
54.5 kg. of deionized water are then heated to 92 -
95 C and 0.2 kg. of methylparaben are added with moderate
mixing at this temperature. The mixing is continued until
the methylparaben is completely dissolved.
The aqueous solution is then slowly added to the
oily blend with moderate mixing. When the addition is
completed, the mixing speed is increased until the batch
is uniform. The batch is maintained at 90 - 95C.
The batch is then rapidly cooled to 60C and mixed
at this temperature for about 3~ minutes and then cooled
to 50C with continued mixing. At the same time, 0.2 kg.
of quaternium-15 are dissolved in 0.5 kg. of deionized
Bl5a
-15-
water. This aqueous solution is then added slowly to
the batch with mixiny until the batch is again
uniform, i.~., about 15 minutes. The resulting
batch is then cooled to room temperature with
continued mixing and then homogenized to yield
lO0 kg. of the final product.
Examples 5 and 6
. . . _
Sunscreen formulations having a sun protection
factor value of 7 and 8 respectively. The ingre-
dients are listed on a weight percent basis and boththe CTFA and trade name are included. Both formu-
lations are water in oil type emulsions having a
lotion consistency.
Deionized_Water 60.05 60.55
Polyethylene (homopolymer) 3.50 3.50
(Allied Chemical A-C 617A, average
molecular weight 1500,
density of 0.91 g./cc.)
20 UV-A absorbing agent O.S0 0.60
2-Hydroxy-4-methoxybenzophenone
(oxybenzone, Uvinyl M-40)
UV-B absorbing agent 3.0 3.50
4-(Dimethylamino)benzoic acid,
25 2-ethylhexyl ester (Escalol 507)
Humectant
Propylene glycol S.00 --
Glycerin __ 5.00
B15a
-16-
Emollients
Mineral oil (Blandol) 11.48 --
Mineral oil (Klearol) -- 20.88
5 Pristane 10.00 --
Emul ifiers
Polyoxyethylene (3) oleyl ether3.50 3.50
(Oleth-3, Volpo 3)
Polyglyceryl-4 oleate (Witconol 14) 1.50 1.50
Polysor~ate 80 (Tween 80) 0.50 0.50
Preservatives
Methylparaben (Tegosept M) 0.2 0.2
Propylparaben (Tegosept P) 0.1 0.1
Quaternium-15 (N(3-chloroallyl)-
hexaminium chloride, Dowicil 200) 0.15 0.15
Antioxidant
Propylene glycol and but~lated0.02 0.02
hydroxyanisole and propyl gallate
and citric acid (Tenox 2)
20 Fragrance 0,50 __
These formulations are prepared according to
the procedure set forth in the pre~ious examples.
The final products are lotions which are more fluid
than the formulations of Example 1 to 4.
Examples 7 and 8
The following sunblock and sunscreen formula-
.
tions can also be prepared according to the procedureof Example 3. Again, the ingredients are listed on
a weight percent basis and both the ~TFA and trade
name are included. Both formulations are water in
* Trade Mark
B
.
. .
B15a
-17-
oil type emulsions. ~he formulation of Example 7
is a thick lotion or cream whereas that of Example 8
is more fluid
7 8
5 _eionized water 55.00 60.55
Polyethylenc (Vinyl acetate 5.5 3.5
_
copolymer)
(Allied Chemical A-C 400,
average molecular weight 3500,
density of 0.92 g./cc.)
UV-A absorbing agents
2-Hydroxy-4-methoxybenzophenone 2.5 0.6
(oxybenzone, Uvinul M-40)
2,2'-Dihydroxy-4-methoxybenzo- 0.5 --
phenone (dioxybenzone, Spectra-
Sorb UV24)
UV-B absorbing agent
4-(Dimethylamino)benzoic acid, 7.0 3.5
2-cthylhexyl ester (Escalol 507)
~mollients
Mineral oil (Blandol) 13.48 --
Mineral oil (Klearol) -- 20.88
Octyl palmitate (Ceraphyl 368) 8.00 --
Sesame oil 2.00 --
25 Cocoa butter 0-50 -~
Humectant
Glycerin -- 5.0
1~8~
B15a
-18-
7 8
~mulsifiers
Polyoxyethylene (3) oleyl ether 3.50 3.50
(Oleth-3, Volpo 3)
Polyglyceryl-4 oleate 1.50 1.50
(Witconol 14)
Polysorbate 80 (Tween 80) -- 0.50
Preservatives
Methylparaben (Tegosept M) 0.20 0.20
Propylparaben (Tegosept P) 0.10 0.10
Quaternium-15 (N-(3-Chloro- 0.20 0.15
allyl)-hexaminium chloride,
Dowicil 200)
Antioxidant
15 Propylene glycol and butylated ~02 ~02
hydroxyanisole and propyl gallate
and citric acid (Tenox 2)
~128~
~15a
-19-
Example 9
The UV absorption of two similar formulations
one containing polyethylene (P) and the other
without polyethylene (NP) are compared. The
ingredients are listed on a weight percent
basis.
P NP
Deionized Water 55.00 55.00
Polyethylene
10 (Allied Chemical A-C 6A) 5.50 --
UV-A absorbing agent
2-Hydroxy-4-methoxybenzo 2.50 2.50
phenone (oxybenzone, Uvirlul
M-40)
15 2,2'-Dihydroxy-4-methoxybenzo-0.5 0.5
phenone (dioxybenzone, Spectra-
Sorb UV24)
UV-B absorbing agent
4-(Dimethylamino)benzoic acid, 7.00 7.00
2-ethylhexyl ester (~scalol 507)
Emollients
Mineral oil (Blandol) 13.48 18.98
Squalane ¦Robane) - 8.00 8.00
~15a
-20-
P NP
Emollients (continued)
Sesame oil 2.00 2.00
Cocoa butter 0.50 0.50
Emulsifiers
Polyoxyethylene (3) oleyl ether3.50 3.50
(Oleth-3, Volpo 3)
Rolyglyceryl-4 oleate (Witconol 14) 1.50 1.50
Preservatives
Methylparaben (Tegosept M) 0.20 0.20
Propylparaben (Tegosept P) 0.10 0.10
Quaternium-15 (N-(3-chloroallyl)- 0.20 0.20
hexaminium chloride, Dowicil 200)
Antioxidant
1 ~
Propylene glycol and butylated0.02 0.02
hydroxyanisole and
propyl gallate and citric acid
(Tenox 2)
The two formulations are prepared in essen-
tially the same manner and are evaluated in vitro
according to the procedure of Cumpelik, "Analytical
Procedures and Evaluation of Sunscreens", J. Soc.
Cosmet. Chem., 23, p. 333-345 (1972).
Thin film samples of each formula are hot air
dried and the ultraviolet absorbance is recorded at
from 2~0 to 400 nm. Using these values, the percent of
ultraviolet transmitted in the erythemal (sun burning)
region of 292.5 to 342.5 nm. and in the tanning region
of 322.5 to 372.5 nm. are calculated. Of course, the
greater the percent ultraviolet transmitted by the
3 formulation the less protection it affords.
Each formulation is tested three times. For
the polyethylene containing formulation (P), the relative
average percent transmitted erythemal is 5.105 and the
relative average percent transmitted tan is 19.569.
Bl 5~1
--21--
For the none polyethylene formulation (NP), the relative
average percent transmitted erythemal is 6.58 and the
relative average percent transmitted tan is 55.23.
Thus, the none polyethylene formulation (NP) transmitted
S 1.28 times the polyethylene formulation (P) in the erythe-
mal region and 2.82 times the polyethylene formulation in
the tanning region.
