U.S. patent application number 09/800088 was filed with the patent office on 2001-12-20 for method for testing sunscreens.
Invention is credited to Klein, Kenneth, Stewart, Ernest Glading.
Application Number | 20010053348 09/800088 |
Document ID | / |
Family ID | 25352279 |
Filed Date | 2001-12-20 |
United States Patent
Application |
20010053348 |
Kind Code |
A1 |
Stewart, Ernest Glading ; et
al. |
December 20, 2001 |
Method for testing sunscreens
Abstract
The sunscreen or makeup may be applied to a person who is wet,
or even underwater, yet it will provide the full efficacy which it
would have had had it been applied to the person when their skin
was dry. In addition, it will be effective from the time that it is
first applied, so no waiting period is required, as was the case
for the so-called "water resistant" and "waterproof" sunscreens of
the prior art. A series of test procedures which illustrate the
efficacy of the "wet-appliable" sunscreens of the present invention
are disclosed.
Inventors: |
Stewart, Ernest Glading;
(Thomasville, GA) ; Klein, Kenneth; (Fair Lawn,
NJ) |
Correspondence
Address: |
Sanford J. Asman, Esq.
570 Vinington Court
Dunwoody
GA
30350
US
|
Family ID: |
25352279 |
Appl. No.: |
09/800088 |
Filed: |
March 6, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09800088 |
Mar 6, 2001 |
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08868766 |
Jun 4, 1997 |
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6197281 |
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Current U.S.
Class: |
424/59 ; 424/400;
424/401; 424/60 |
Current CPC
Class: |
A61K 8/06 20130101; A61K
8/29 20130101; A61Q 17/04 20130101; A61K 8/894 20130101; A61K 8/27
20130101; A61K 8/37 20130101; A61K 8/891 20130101; A61K 49/0006
20130101; A61Q 1/02 20130101 |
Class at
Publication: |
424/59 ; 424/60;
424/401; 424/400 |
International
Class: |
A61K 007/42; A61K
007/44; A61K 007/00 |
Claims
I claim:
1. A sunscreen which may be applied to wet skin which provides
instant, waterproof protection upon application, said sunscreen
comprising: (a) a primary water-in-oil emulsifier; and (b) at least
one sunscreen selected from the group consisting of an oil soluble
sunscreen and an inorganic sunscreen.
2. The sunscreen of claim 1 further comprising at least one
lipophillic emollient.
3. The sunscreen of claim 2 wherein the lipophillic emollient is a
volatile emollient.
4. The wet appliable sunscreen of claim 3 wherein the primary
water-in-oil emulsifier is selected from the group consisting of
dimethicone and dimethicone copolyol.
5. The wet appliable sunscreen of claim 4 wherein the primary
water-in-oil emulsifier is present by weight percentage of between
2% and 10%.
6. The wet appliable sunscreen of claim 4 wherein the primary
water-in-oil emulsifier is present by weight percentage of about
8%.
7. The wet appliable sunscreen of claim 4 wherein the primary
water-in-oil emulsifier is selected from the group consisting of SF
1328, Arlacel P135, DC 3225C, DC 5200, Abil EM-90, and Abil
WE-09.
8. The wet appliable sunscreen of claim 3 wherein the volatile
emollient is selected from the group consisting of cyclomethicone,
low molecular weight dimethicones, and Permethyls.
9. The wet appliable sunscreen of claim 8 wherein the volatile
emollient is present in a weight percentage of between about 5% and
20%.
10. The wet appliable sunscreen of claim 3 wherein the volatile
emollient is present in a weight percentage of about 5%.
11. The wet appliable sunscreen of claim 3 wherein the oil soluble
sunscreen is octyl methoxycinnamate.
12. The wet appliable sunscreen of claim 3, further comprising a
substance to provide stabilization, thickening, and water
resistance selected from the group consisting of siliconyl beeswax,
polyethylene hydrogenated castor oil, beeswax, alkyl modified
silicones, mineral waxes, and vegetable waxes.
13. The wet appliable sunscreen of claim 3, further comprising a
non-volatile emollient ester.
14. The wet appliable sunscreen of claim 13, wherein said
non-volatile emollient ester is diisodecyl adipate.
15. The wet appliable sunscreen of claim 3, further comprising a
stabilizer.
16. The wet appliable sunscreen of claim 15 wherein said stabilizer
is Arlacel P135.
17. The wet appliable sunscreen of claim 3, further comprising a
film thickener.
18. The wet appliable sunscreen of claim 17 wherein said film
thickener is selected from the group consisting of Ganex V220,
polyethylene, PVP polymers, and acrylate resins.
19. The wet appliable sunscreen of claim 3, further comprising a
fragrance.
20. The wet appliable sunscreen of claim 19 wherein said fragrance
is MF-3871.
21. The wet appliable sunscreen of claim 3, further comprising an
antioxidant.
22. The wet appliable sunscreen of claim 21 wherein said
antioxidant is vitamin E acetate.
23. The wet appliable sunscreen of claim 3, further comprising a
hydrophilic surfactant.
24. The wet appliable sunscreen of claim 23 wherein said
hydrophilic surfactant is Plantaren 2000.
25. The wet appliable sunscreen of claim 3, further comprising a
preservative.
26. The wet appliable sunscreen of claim 25 wherein said
preservative is Germaben II.
27. The wet appliable sunscreen of claim 3, further comprising a
salt.
28. The wet appliable sunscreen of claim 27 wherein said salt is
selected from the group consisting of sodium chloride, magnesium
sulfate, and potassium chloride.
29. The wet appliable sunscreen of claim 3 further comprising
deionized water.
30. The sunscreen of claim 1 wherein the inorganic sunscreen is
selected from the group consisting of titanium dioxide and zinc
oxide.
31. A sunscreen ointment which can be applied to a wet human which
provides instant protection comprising: (a) petroleum jelly; and
(b) an oil soluble sunscreen.
32. A sunscreen gel which can be applied to a wet human which
provides instant protection comprising: (a) mineral oil; (b) an
emollient; and (c) an oil soluble sunscreen.
33. The sunscreen gel of claim 32 in which the emollient is
cyclomethicone.
34. The sunscreen gel of claim 33 in which the oil soluble
sunscreen is octyl methoxycinnamate.
35. The sunscreen gel of claim 34 comprising: (a) mineral oil in
about 35.65 weight percent; (b) DC 345 cyclomethicone in about
33.00 weight percent; and (c) octyl methoxycinnamate in about 7.50
weight percent.
35. The sunscreen gel of claim 34 further comprising an alkyl
galactomannan material.
36. The sunscreen gel of claim 35 wherein the alkyl galactomannan
material is selected from the group consisting of N'Hance AG 50 and
AG200.
37. A wet appliable sunscreen comprising: (a) about 8% SF 1328; (b)
about 5% DC 345; (c) about 7.5% ESCALOL 557; (d) about 5% Trivent
DIDA; (e) about 4% Escalol 567; (f) about 2% siliconyl beeswax; (g)
about 1% Arlacel P135; (h) about 2% Ganex V220; (i) about 0.25%
Fragrance MF-3871; (j) about 0.50% Vitamin E Acetate; (k) about
0.10% Plantaren 2000; (l) about 1% Sodium Chloride; (m) about 1%
Germaben II; and (n) about 62.65% deionized water.
38. A procedure for testing the efficacy of a wet-appliable
sunscreen comprising: (a) placing subjects into a hot, high
humidity room until they have been sweating profusely for about 10
minutes; (b) applying a sunscreen product to be tested and a
control product to said subjects while they are in said hot room;
and then (c) removing said subjects from said hot room and
evaluating the SPF of the product being tested as compared to said
control product.
39. A procedure for testing the efficacy of a wet-appliable
sunscreen comprising: (a) submerging subjects in whirlpool
containing water; (b) applying a sunscreen product to be tested and
a control product to said subjects while they are in said
whirlpool; and then (c) removing said subjects from said whirlpool
and evaluating the SPF of the product being tested as compared to
said control product.
40. A procedure for testing the efficacy of a wet-appliable
sunscreen comprising: (a) wetting the backs of subjects using
water; (b) applying a sunscreen product to be tested and a control
product to the backs of said subjects while they are wet; (c)
allowing the sunscreen products to dry for about twenty minutes;
and then (d) immersing said subjects in a whirlpool; and then (e)
removing said subjects from said whirlpool and evaluating the SPF
of the product being tested as compared to said control
product.
41. A procedure for testing the efficacy of a wet-appliable
sunscreen comprising: (a) applying a sunscreen product to be tested
and a control product to subjects; and (b) then without awaiting
the drying of said sunscreen products, immediately evaluating the
SPF of the product being tested as compared to said control
product.
42. A method of providing instant sun protection to a human,
comprising: applying to said human a water-in-oil sunscreen
emulsion comprising: (a) a primary water-in-oil emulsifier; (b) at
least one volatile emollient; (c) an oil soluble sunscreen; and (d)
an inorganic sunscreen selected from the group consisting of
titanium dioxide and zinc oxide.
43. A method of providing sun protection to a human having wet
skin, comprising: applying to the wet skin of said human an oil
soluble sunscreen.
44. The method of claim 43 in which said sunscreen emulsion further
comprises: (a) a primary water-in-oil emulsifier; and (b) at least
one volatile emollient.
45. A method of providing instant sun protection to a human
comprising: applying to the wet skin of said human an oil soluble
sunscreen.
46. A makeup providing instant sunscreen protection which
comprises: (a) about 8.00% SF 1328 without emulsifier; (b) about
5.00% cyclomethicone DC 345; (c) about 4.00% octyl stearate; (d)
about 2.00% aluminum stearate; (e) about 1.25% Castorwax MP 70; (f)
about 1.00% siliconyl beeswax; (g) about 7.50% octyl
methoxycinnamate; (h) about 2.00% oxybenzone; (i) about 3.00%
Z-cote zinc oxide; (j) about 15.00% titanium dioxide #328; (k)
about 0.50% red iron oxide #7067; (l) about 1.00% yellow iron oxide
#7059; (M) about 1.80% brown iron oxide #7050; (n) about 0.10%
black iron oxide #7133; (o) about 46.15% deionized water; (p) about
0.10% Planteren 2000; (q) about 0.60% sodium chloride; and (r)
about 1.00% Germaben IIE.
Description
BACKGROUND OF THE INVENTION
[0001] The present invention relates to sunscreens. In particular,
the present invention relates to sunscreens which can be applied to
a person whose skin is wet or dry and which achieves its full SPF
instantly, irrespective of whether it was applied to wet or dry
skin. The invention further relates to inventive procedures for
testing the effectiveness of sunscreens.
[0002] In recent years, the dangers of exposing the skin to direct
sunlight have become known. Consequently, the concept of having a
"healthy" tan has changed to one of protecting the skin from the
harmful effects caused by exposure, particularly to the ultraviolet
("UV") rays of the sun, which have been shown to cause many skin
problems, including cancers, such as melanoma. These effects have
been shown to be cumulative over a person's life, and no way has
been found to reverse these effects.
[0003] Accordingly, modem thinking involves not exposing one's skin
to the direct rays of the sun unless the skin is either covered or
otherwise protected. Numerous sunscreen products are available to
protect the skin from the harmful rays of the sun. These sunscreen
products are rated based upon their ability to protect the user's
skin, using a rating system which is based upon a Sun Protection
Factor ("SPF") rating. The higher the SPF of a sunscreen, the
greater the amount of protection which the sunscreen provides to a
user.
[0004] Among the various sunscreens which are available are a
number which are called either "water resistant" or "waterproof".
What consumers do not generally recognize, however, is that such
sunscreens are only water resistant or waterproof after they have
been applied to the user, and after they have been allowed to dry,
whereby they are, themselves, protected from water by a thin film.
In accordance with the instructions and test procedures used with
such so-called "water resistant" and "waterproof" sunscreens of the
prior art, and generally not known by, or, alternatively,
disregarded by, consumers, is that the sunscreens must be applied
to the dry skin of a user in order for them to have the SPF which
they claim to have. In fact, the very test procedures heretofore
used to test the efficacy of sunscreens requires that the
sunscreens be applied only to dry skin.
[0005] The so-called "water resistant" and "waterproof" sunscreens
of the prior art, must all be applied to dry skin, then allowed to
dry on the user's skin for a period of time, typically twenty
minutes, before they are effective. In fact, while no rules have
been adopted by the federal Food and Drug Administration ("FDA"),
the industry has operated pursuant to the proposed rules which were
published on May 12, 1993 in Volume 58, No. 90 of the Federal
Register, which require a waiting period of at least 15 minutes
before exposure prior to testing the SPF of a sunscreen. Similarly,
the proposed rules also set forth a methodology for determining the
water resistance of a sunscreen product. In accordance with the
water resistance testing, a determination is made as to whether a
sunscreen is able to retain the same Product Category Designation
("PCD"). As is known by those skilled in the art, the PCD of a
sunscreen is based upon its SPF value, as follows: "minimal" means
the sunscreen has an SPF from 2 to less than 4; "moderate" means
the sunscreen has an SPF from 4 to less than 8; "high" means the
sunscreen has an SPF from 8 to less than 12; "very high" means the
sunscreen has an SPF from 12 to less than 20; and "ultrahigh" means
the sunscreen has an SPF of from 20 to 30.
[0006] In reality, many people who are out in the sun have wet skin
prior to their applying any sunscreen agent. Such people are often
engaged in activities associated with a proximity to water, such as
swimming, boating, or fishing which are conducive to their skin
becoming wet. Alternatively, people who are out in the hot sun, or
are engaged in strenuous outdoor activities, such as sports, are
prone to sweating, which also causes their skin to become wet.
[0007] The application of a sunscreen to wet skin, even those
sunscreens which are "water resistant" or "waterproof" is contrary
to their instructions for use and prevents them from having the
efficacy which they proclaim to have when applied properly to dry
skin and allowed to dry for the requisite time prior to the person
being exposed to the sun.
[0008] In view of the foregoing, a new class of sunscreens, i.e.,
sunscreens which can be applied directly to wet skin, is needed. In
addition, cosmetics, such as makeup, can be formulated to include
the instant protection and "wet-appliable" benefits of the present
invention. Finally, procedures for testing such "wet-appliable"
sunscreens for efficacy are also needed.
SUMMARY OF THE INVENTION
[0009] In accordance with the present invention, a new class of
"wet-appliable" sunscreens and makeup has been developed. These
sunscreens can be applied to the wet skin of a user, yet they will,
nevertheless, provide the user with the efficacy and SPF levels
which are claimed. In addition, whether applied to wet or dry skin,
the sunscreens of the present invention are immediately effective
to provide protection to their PCD upon application, so no waiting
time is required before the user can go into the sun or engage in
activities in which their skin will become wet.
[0010] In addition, new procedures have been invented which are,
for the first time, capable of being used to test the effectiveness
of sunscreens with respect to how quickly they become effective and
their ability to be applied while wet, while remaining
effective.
DETAILED DESCRIPTION OF AN EXEMPLARY EMBODIMENT
[0011] Practically all sunscreen products sold in the United States
are emulsions. and virtually all of them are of the oil-in-water
type. While water-in-oil sunscreen emulsions are well known, they
have not enjoyed popularity due to their greasiness. Recent
advances in technology have allowed for greatly improved versions
of water-in-oil sunscreens. Nevertheless, oil-in-water sunscreens
predominate by a vast margin. Unfortunately, these popular
oil-in-water sunscreens are not inherently waterproof, so even the
FDA requires that they be "reapplied" after swimming and/or
perspiring. Reapplying an oil-in-water sunscreen emulsion results
in smearing and uneven application of the sunscreen due to the fact
that oil-in-water emulsions have water as their external phase.
Thus, when an oil-in-water sunscreen emulsion is applied to wet
skin the external (water) phase is diluted and the result is poor
and uneven application. The present invention uses oil and
silicones as the external phase, so no similar problems occur. The
water-in-oil emulsion of the present invention is inherently
waterproof since it contains a great predominance of lipophillic
emulsifier. The result is a uniform and thick sunscreen film which
remains on the skin, even when it is applied over wet skin. In
fact, one could even apply the sunscreen product of the present
invention underwater.
[0012] In accordance with the present invention, a new class of
"wet-appliable" sunscreens and makeup has been developed. These
"wet-appliable" sunscreens and makeup are not only water resistant
or waterproof, after they have been applied to the user, but they
may be applied to a user whose skin is wet when they are
applied.
[0013] In addition, the "wet-appliable" sunscreens and makeup of
the present invention do not require any waiting time before they
are effective to their designated SPF level. Consequently, the
"wet-appliable" sunscreens and makeup of the present invention
differ from the "water resistant" and "waterproof" sunscreens
heretofore known in that they (1) may be applied to a person whose
skin is wet; and (2) they are immediately effective when they
applied, rather than after they have been first allowed to dry for
a predetermined time.
[0014] The "wet-appliable" sunscreens and makeup of the present
invention are based upon human skin being lipophilic, i.e., "oil
loving", rather than hydrophilic, i.e., "water loving". That means
that when the sunscreens of the prior art, which are typically
oil-in-water emulsions, are applied to wet skin, they become milky
and discontinuous. Accordingly, as the sunscreens of the prior art
were intended to be applied to dry skin, then allowed to dry for a
predetermined period of time (e.g., twenty minutes) prior to the
user being exposed to the sun, it did not matter that they were
oil-in-water emulsions. In reality, however, many people are not
aware of the instructions which accompany sunscreens, or else they
disregard these instructions. Consequently, they tend to apply
sunscreens to their skins when they are wet, either from engaging
in water activities, such as swimming, boating, and fishing, or
from engaging in sports activities or when out in the hot sun,
whereby their own sweat has wet their skin. In either case, when a
sunscreen of the prior art is applied, the water on the user's skin
prevents the sunscreen from drying properly to form a skin, which
in the case of "water resistant" and "waterproof" sunscreens, would
thereafter be protected from water, had it only been applied in
accordance with its instructions. Lacking proper application the
sunscreens of the prior art are unable to provide the protection
which their labeling calls for, thereby leaving the user exposed to
the very dangers which they thought they were avoiding by the
application of the sunscreen.
[0015] In accordance with the present invention sunscreens and
makeup are formulated with the specific intent that they can be
applied to wet skin, i.e., a "wet-appliable" sunscreen, is
described. Unlike the sunscreens of the prior art, which are
oil-in-water emulsions, the "wet-appliable" sunscreens and makeup
of the present invention are water-in-oil emulsions. In particular,
the preferred embodiment of the present invention makes use of a
water-in-oil emulsifier containing at least one volatile emollient,
and an oil soluble sunscreen. In specific embodiments of the
invention, other constituents may also be present. In particular,
it has been found that a "wet-appliable" sunscreen, which can be
applied to a person having wet skin, or even to a person who is
under water, can be formulated using the ingredients disclosed
herein.
[0016] First, it has been discovered that if water is to be present
in the sunscreen, then a water-in-oil emulsifier must be used. In
accordance with the preferred embodiment of the present invention,
a water-in-oil emulsifier, such as SF1328 is used in a percentage
of between about 2-10%. SF1328 is a water-in-oil emulsifier
supplied by GE Silicones. The chemical name for SF1328 is
dimethicone (and) dimethicone copolyol. Other water-in-oil
emulsifiers which could be used in place of SF1328 include Arlacel
P135 (ICI), DC 3225C (Dow Corning), DC 5200, Abil EM-90, Abil WE-09
(Goldschmidt). Those skilled in the art will recognize that there
are several other water-in-oil emulsifiers which could also be used
in place of SF 1328.
[0017] Next a volatile emollient, such as DC 345, which is a
volatile emollient supplied by Dow Corning is used in a percentage
of between about 5-20%. The chemical name of DC 345 is
cyclomethicone. Those skilled in the art will again recognize that
there are numerous other volatile emollients which could be used in
lieu of DC 345, including low molecular weight dimethicones 0.65
cs-50 cs (Dow Corning) and Permethyls (hydrocarbons) supplied by
Presperse Co.
[0018] An oil soluble sunscreen, such as Escalol 557, whose drug
name is octyl methoxycinnamate, is used in a level of between about
2.0-7.5%. Any other Federal Food and Drug Administration (FDA)
approved oil soluble UVB sunscreens can be used in the United
States. Outside of the United States, any locally approved, oil
soluble sunscreen could be used without departing from the present
invention.
[0019] As set forth above, other substances may optionally be added
to the "wet-appliable" sunscreen of the present invention in order
to improve the ultimate formulation. These other substances include
siliconyl beeswax, which is preferably used to a level between
about 0.25-5.0%, and which is supplied by Koster Kuenen. The
function of the siliconyl beeswax is to provide emulsion
stabilization and waterproofing. Additionally it thickens the
emulsion. Other materials which would accomplish these purposes,
and which could, therefore, be used in lieu of the siliconyl
beeswax, include polyethylene hydrogenated castor oil, beeswax,
silica, alkyl modified silicones, mineral waxes, and/or vegetable
waxes.
[0020] A non-volatile emollient ester is also used in the preferred
embodiment of the invention. In the preferred embodiment, the
non-volatile emollient ester which is used is called Trivent DIDA,
whose chemical name is diisodecyl adipate, and which is supplied by
Trivent Chemical Co., is used to a level of about 2-10%. Those
skilled in the art will recognize that many other non-volatile
emollient esters, or other lipophiles, could be used in place of
Trivent DIDA.
[0021] In the preferred embodiment of the invention a number of
other substances are included in the formulation. These include
Arlacel P135, whose chemical name is PEG-30 dipolyhydroxystearate
is a secondary water-in-oil emulsifier which is supplied by ICI.
The purpose of the Arlacel P135 is to stearically stabilize the
water-in-oil emulsion. The Arlacel P135 may be replaced by any
typically employed water-in-oil emulsifier. As will be understood
by those skilled in the art, the purpose of having a secondary
water-in-oil emulsifier (which is present in a lower concentration
than the primary water-in-oil emulsifier) is to provide a more
stable emulsion The preferred embodiment of the invention also
includes Ganex V220, which is a film thickener supplied by ISP
Chemical Co. It functions as a film thickener, SPF booster, and as
a waterproofing agent. As will be recognized by those skilled in
the art, the Ganex V220 may be replaced by a number of other
polymers that could function in similar manner, such as
polyethylene, other PVP polymers, and acrylate resins.
[0022] The preferred embodiment of the invention also includes
Fragrance MF-3871, which is a fragrance used for its organoleptic
effect, i.e., it makes the formulation smell good. MF 3871, which
is supplied by Mane USA, can be replaced by numerous other suitable
oil soluble fragrances without departing from the present
invention.
[0023] The preferred embodiment of the invention also includes
Vitamin E Acetate, which is an antioxidant, and a free radical
scavenger which is supplied by BASF Corporation. The purpose of the
Vitamin E Acetate is to provide those benefits which are provided
by antioxidents and free radical scavengers, although it is not
needed for the present invention.
[0024] The preferred embodiment of the invention also includes
Plantaren 2000, which is a hydrophilic surfactant which is supplied
by Henkel Corporation. The purpose of the Plantaren 2000, which is
used in level of between about 0.05% to 1.0% (by weight), is to
stabilize the emulsion. The chemical name for Pantaren 2000 is
lauryl polyglucose supplied by Henkel Corp. It functions as a
hydrophilic surfactant to complex at the interface and provides a
more uniform and stable interface, thereby stabilizing the
emulsion. It is as a surfactant for shampoos and shower washes,
rather than in the manner in which it is used in the present
inventions. Many other hydrophilic emulsifiers/surfactants could be
used in place of the Plantaren 2000.
[0025] The preferred embodiment of the invention also includes
Germaben II, which is a preservative, which is supplied by Sutton
Laboratories/ISP Corporation. The purpose of the Germaben II is to
preserve the emulsion. The Germaben II, is preferably used in a
level of between about 0.5% to about 1.5% by weight. It functions
as a preservative. There are numerous other preservatives that
could be used.
[0026] The preferred embodiment of the invention also includes
sodium chloride. The purpose of the sodium chloride is to stabilize
the water-in-oil emulsion. The sodium chloride may be replaced by
magnesium sulfate or potassium chloride. Use levels of about
0.2-2.0%.
[0027] Finally, the preferred embodiment of the invention is
formulated with deionized water, as an internal phase diluent as
set forth more fully hereinafter.
[0028] The formulation of the preferred embodiment of the sunscreen
of the present invention is as follows:
Example 1--Sunscreen
[0029]
1 BATCH SIZE # PHASE INGREDIENT % W/W 500.00 1 A SF 1328 EMULSIFIER
8.00 40.00 2 A DC 345 CYCLOMETHICONE 5.00 25.00 3 A ESCALOL 557
(SUNCREEN) 7.50 37.50 4 A TRIVENT DIDA 5.00 25.00 5 A ESCALOL 567
(SUNSCREEN) 4.00 20.00 6 A SILICONYL BEESWAX 2.00 10.00 7 A ARLACEL
P135 1.00 5.00 8 A GANEX V220 2.00 10.00 9 A FRAGRANCE MF-3871 0.25
1.25 10 A VITAMIN E ACETATE 0.50 2.50 11 B DEIONIZED WATER 62.65
313.25 12 B PLANTAREN 2000 0.10 0.50 13 B SODIUM CHLORIDE 1.00 5.00
14 B GERMABEN II 1.00 5.00 TOTAL 100.00 500.00
[0030] In the foregoing formulation, SF1328 is the primary
emulsifier. In accordance with the present invention, the primary
emulsifier is present in a concentration of between about 2% to
about 20% by weight, and it is preferably present in a
concentration of between about 5% to about 10%.
[0031] The Arlacel P135 acts as the secondary emulsifier. In
accordance with the present invention, the secondary emulsifier is
present in a concentration of between about 0.25% to about 4% by
weight, and it is preferably present in a concentration of between
about 0.5% to about 1.5%. The secondary emulsifier helps to
stabilize the formulation.
[0032] The Plantaren 2000 is a hydrophilic emulsifier which
functions to stabilize the oil/water interface. In accordance with
the present invention, the primary emulsifier is present in a
concentration of between about 0.05% to about 0.5% by weight, and
it is preferably present in a concentration of between about 0.05%
to about 0.2%.
[0033] In order to manufacture the sunscreen of the Example 1,
Phase A is heated to about 75.degree. C. and it is mixed to
uniformity.
[0034] Next, Phase B is combined and Phase B is added to Phase A
very slowly under good agitation.
[0035] Finally, the combined Phases A and B are packaged.
2 # PHASE INGREDIENT % W/W 1 A DEIONIZED WATER 34.30 2 A PROPYLENE
GLYCOL 2.00 3 B AVOBENZONE 2.00 4 B OCTYL METHOXYCINNAMATE 7.50 5 B
OXYBENZONE 6.00 6 B SF 1328 EMULSIFIER 5.00 7 C WATER, DEIONIZED
40.00 8 C CARBOMER 0.20 9 D PEG-40 STEARATE 0.30 10 D GANEX V220
2.00 11 E TRIETHANOLAMINE 99% 0.20 12 F PRESERVATIVE 0.50 TOTAL
100.00
[0036] To make the water-in-oil-in-water sunscreen emulsion
formulation of Example 2, Phase A is heated to 75.degree. C. Phase
B is heated to 75.degree. C., and Phase A is added to Phase B.
Phase D is added to Phase C. Phase A/B is added to Phase C/D. Phase
E is added and the combination is allowed to cool to 45.degree. C.,
and then Phase F is added, to complete the formulation.
Sunscreen Ointment
[0037] While it has been discovered that a water-in-oil emulsifier
must be used in order to make a wet appliable sunscreen in which
the formulation contains water, as described above, if an ointment
is desired, then there is no water in the formulation. So, in
accordance with another embodiment of the invention, a sunscreen
ointment which provides instant protection, but which does not
contain water can be formulated with an oil soluble sunscreen as
described in Example 3:
3 # PHASE INGREDIENT % W/W 1 A PETROLATUM 71.10 2 A CARNUBA WAX
1.00 3 A CERESIN WAX 3.00 4 A SILCONYL BEESWAX 2.00 5 B OCTOCRYLENE
9.00 6 B OXYBENZONE 6.00 7 B OCTYL METHOXYCINNAMATE 7.50 8 C
FRAGRANCE 0.40 TOTAL 100.00
[0038] Example 3 is an SPF 30 ointment.
[0039] In order to manufacture the sunscreen ointment of Example 3,
Phase A is heated to 85.degree. C. and mixed to uniformity. Then,
Phase B is combined and added to Phase A. The formulation is then
mixed to uniformity and packaged.
Makeup
[0040] Makeup containing a sunscreen, which can be applied over wet
skin, is also within the scope of the present invention. A
formulation for such a makeup is described in Example 4:
Example 4--Makeup with Sunscreen Protection
[0041]
4 BATCH SIZE # PHASE INGREDIENT % W/W 500.00 1 A SF 1328 WATER IN
OIL 8.00 40.00 EMULSIFIER 2 A CYCLOMETHICONE DC 345 5.00 25.00 3 A
OCTYL STEARATE 4.00 20.00 4 A ALUMINIUM STEARATE 2.00 10.00 5 A
CASTORWAX MP70 1.25 6.25 6 A SILICONYL BEESWAX 1.00 5.00 7 A OCTYL
METHOXYCINNAMATE 7.50 37.50 8 A OXYBENZONE 2.00 10.00 9 B Z-COTE
ZINC OXIDE 3.00 15.00 10 B TITANIUM DIOXIDE #328 15.00 75.00 11 B
RED IRON OXIDE #7067 0.50 2.50 12 B YELLOW IRON OXIDE #7059 1.00
5.00 13 B BROWN IRON OXIDE #7050 1.80 9.00 14 B BLACK IRON OXIDE
#7133 0.10 0.50 15 C DEIONIZED WATER 46.15 230.75 16 C PLANTAREN
2000 0.10 0.50 17 C SODIUM CHLORIDE 0.60 3.00 18 C GERMABEN II 1.00
5.00 TOTAL 100.00 500.00
[0042] In the foregoing makeup formulation, the SF1328 has a water
in oil emulsifier.
[0043] In order to manufacture the makeup of Example 4, Phase A is
heated about 80.degree. C. Next, Phase B is added very slowly under
moderate agitation. Next, Phase C is heated to 60.degree. C., and
added to the batch. Finally, the combined Phases A, B, and C are
packaged.
[0044] The following three formulations also provide instant
protection products that may be applied to wet skin. These
formulations may make use of a new material, available from
Hercules, called N'Hance AG 50 or AG200. These materials are alkyl
galactomannan materials which act to thicken ointments, to create
clear oil based gels, and to stabilize water-in-oil emulsions.
Additionally, it will be understood by those skilled in the art
that mention commonly utilized oil phase thickeners, such as
polyvalent soaps (i.e., aluminum stearate, calcium stearate,
magnesium stearate, or zinc stearate) or silica based materials
(i.e., fumed silica Cab-O-Sil M5) can be used.
Sunscreen Gel
[0045] In one embodiment of the present invention, a gel based
sunscreen is described. As gels do not include water, no
water-in-oil emulsifier is required. A gel formulation is described
in Example 5:
Example 5--Sunscreen Gel SPF 15
[0046] A sunscreen gel having an SPF 15, which provides instant
protection from the sun and which may be applied to wet skin to
provide instant protection, is made as follows:
5 BATCH SIZE # PHASE INGREDIENT % W/W 500.00 1 A MINERAL OIL 35.65
178.25 2 A DC 345 CYCLOMETHICONE 33.00 165.00 3 A OCTYL
METHOXYCINNAMATE 7.50 37.50 4 A TRIVENT DIDA 5.00 25.00 (DIISODECYL
ADIPATE) 5 A OXYBENZONE 6.00 30.00 6 A N-HANCE AG200 5.00 25.00 7 A
GANEX V220 2.00 10.00 8 B FRAGRANCE MF-3871 0.25 1.25 9 B VITAMIN B
ACETATE 0.50 2.50 10 B PROPYLPARABEN 0.10 0.50 11 B OCTYLDODECANOL
5.00 25.00 TOTAL 100.00 500.00
[0047] The sunscreen gel of Example 5 is manufactured by heating
Phase A to about 85.degree. C. and mixing to uniformity. Then Phase
B is combined and added to Phase A. The mixture is mixed to
uniformity and packaged.
[0048] In Example 6, another sunscreen ointment formulation is
described:
Example 6--Sunscreen Ointment having SPF 15
[0049] A sunscreen ointment having an SPF 15, which provides
instant protection from the sun and which can be applied to wet
skin is made, as follows:
6 BATCH SIZE # PHASE INGREDIENT % W/W 500.00 1 A MINERAL OIL 27.65
138.25 2 A DC 345 CYCLOMETHICONE 33.00 165.00 3 A OCTYL
METHOXYCINNAMATE 7.50 37.50 4 A PETROLATUM 5.00 25.00 5 A TRIVENT
DIDA 5.00 25.00 (DIISODECYL ADIPATE) 6 A CAB-O-SIL M5 FUMED SILICA
3.00 15.00 7 A OXYBENZONE 6.00 30.00 8 A ALUMINUM STEARATE 5.00
25.00 9 A GANEX V220 2.00 10.00 10 B FRAGRANCE MF-3871 0.25 1.25 11
B VITAMIN E ACETATE 0.50 2.50 12 B PROPYLPARABEN 0.10 0.50 13 B
OCTYLDODECANOL 5.00 25.00 TOTAL 100.00 500.00
[0050] In order to manufacture the sunscreen ointment of Example 6,
Phase A is heated to 85.degree. C. and mixed to uniformity. Then,
Phase B is combined and added to Phase A. The formulation is then
mixed to uniformity and packaged.
[0051] In Example 7, a sunscreen oil is described:
Example 7--Sunscreen Oil having SPF 15
[0052] A sunscreen oil having an SPF 15, which provides instant
protection from the sun and which can be applied to wet skin is
made, as follows:
7 BATCH SIZE # PHASE INGREDIENT % W/W 500.00 1 A MINERAL OIL 35.65
178.25 2 A DC 345 CYCLOMETHICONE 33.00 165.00 3 A OCTYL
METHOXYCINNAMATE 7.50 37.50 4 A TRIVENT DIDA 5.00 25.00 (DIISODECYL
ADIPATE) 5 A OXYBENZONE 6.00 30.00 6 A N-HANCE AG200 5.00 25.00 7 A
GANEX V220 2.00 10.00 8 B FRAGRANCE MF-3871 0.25 1.25 9 B VITAMIN E
ACETATE 0.50 2.50 10 B PROPYLPARABEN 0.10 0.50 11 B OCTYLDODECANOL
5.00 25.00 TOTAL 100.00 500.00
[0053] In order to manufacture the sunscreen oil of Example 7,
Phase A is heated to 65.degree. C. and mixed to uniformity. Then,
Phase B is combined and added to Phase A. The formulation is then
mixed to uniformity and packaged.
Testing Procedures
[0054] Prior to the present invention, there was no sunscreen
available which claimed that it had either instant protection or
the ability to be applied to a person whose skin was wet. As people
tend to wait until they are out in the sun before they apply
sunscreens, and as traditional sunscreens have always required
application followed by drying time before they were effective,
traditional sunscreens have been unable to provide the proper level
of protection to people who went out into the sun and then applied
sunscreen. In many cases, people would go out into the sun with the
intention of staying for relatively brief periods, apply
sunscreens, and not realize that they were not effectively
protected to the rated SPF of the applied sunscreen. Thus, by way
of example, someone who was concerned about sunburn, but unaware of
the fact that traditional sunscreens failed to provide their rated
SPF instantly, could have gone out into the sun, applied a
sunscreen, and then removed themselves from the sun after a short
time in an effort to limit their exposure. In such cases, the
sunscreen may never have achieved the desired level of
protection.
[0055] Similarly, when children are taken out to play at recess or
during gym classes, if they were to apply traditional sunscreens,
they would not have sufficient time to allow the sunscreens to dry
prior to the time their outdoor exposure to the sun ended.
[0056] With respect to the other aspect of the formulations of the
present invention, namely their ability to be effectively applied
over wet skin, this is another very important quality of both
sunscreens, which are often applied after bathing or sweating, and
makeup, which is often applied to wet skin.
[0057] While the foregoing qualities of the present inventive
formulations are quite important, heretofore there has been no way
to quantify those qualities. Accordingly, in another aspect of the
present invention, test procedures and methods have been invented
to quantify the effectiveness of sunscreen formulations. These
inventive test procedures can be used to determine the
effectiveness of sunscreens which have been applied and which are
either expected to be effective immediately or which are expected
to have a particular SPF value.
[0058] In accordance with the present invention, a series of tests,
unique to "wet-appliable" and "instant protection" sunscreens, has
been developed. These sunscreen tests provide an inventive
procedure for determining the efficacy of sunscreens, which have
not been present in the "standard" test procedures heretofore used
in connection with testing the sunscreens of the prior art.
[0059] The test procedures of the present invention are described
as follows:
Test I (Standard Test Procedure)
[0060] The standard test procedure used for testing sunscreens is
outlined in the FDA monograph of proposed rules for sunscreen
testing which was published in the Federal Register, Vol. 43, No.
166, Aug. 25, 1978.
[0061] In accordance with the standard procedures for testing
sunscreens, a light source, such as a Xenon Arc Solar Simulator
(150 watts) is used as a source of ultraviolet light irradiation.
Such devices, which provide a spectral output in the ultraviolet
range which is comparable to that of natural sunlight, are
described in detail in J. Invest. Dermatol. 53, 192 (1969), and
they are available from Solar Light Company, Philadelphia, Pa.
[0062] In order to test the SPF, the following procedure is used. A
Minimal Erythemal Dose ("MED") is defined as the time interval or
dosage of UV light irradiation sufficient to produce a minimal
perceptible erythema on untreated skin. Prior to the testing phase,
the MED of each test subject is determined by a progressive
sequence of timed UV light exposures, each of which is graduated
incrementally by 25% over that of the previous site. Twenty-four
hours after irradiation, the sites are evaluated for erythema
according to the following scoring system:
[0063] 0 Negative, no visible reaction
[0064] +/- Minimal erythema
[0065] 1+ Defined erythema
[0066] 2+ Moderate erythema
[0067] 3+ Severe erythema
Determination of SPF Values
[0068] A sufficient number of 5.times.10 cm test site areas are
outlined with a surgical marking pen on the subject's back between
the acapulae and the beltline, lateral to the midline. These areas
are designated for the Test material(s) or Standard, with an
adjacent site designated for a concurrent MED determination
(unprotected control). The tests, as described below, are
conducted. Then the Sun Protection Factor ("SPF") is determined.
The SPF is defined to be: 1 SPF = MED ProtectedSkin MED
UnprotectedControlSite
Test II (Sweat Procedure)
[0069] The intent of having a "sweat" test, is to be able to
determine the effectiveness of a sunscreen which is applied to a
person who has been sweating. Therefore, consistent with the
procedure of the present invention, it is necessary to provide a
panelist with conditions which are conducive to having them sweat,
or, alternatively, to simulate their having been sweating. In
accordance with the preferred embodiment of the present inventive
test procedure a panelist enters the environmentally controlled
"hotroom". The temperature, humidity and air movement are
maintained at levels consistent with thirty (30) minutes of copious
sweating, i.e., temperature of 95.degree. F. to 105.degree. F.,
relative humidity between 60% and 80%; and minimal air movement.
The panelist then sits in the "hotroom" for thirty (30) minutes of
copious sweating. The 30-minute test period begins when the subject
starts to sweat profusely, with drops of sweat running down the
test site. A 0.1 g portion of Test Material is then applied to the
appropriate 5.times.10 cm test site and spread evenly over the site
using a fingercot. This delivers a test film of 2 mg/cm.sup.2.
[0070] A sunscreen product is applied and permitted to dry for 20
minutes. Following the drying period there follow four 20 minute
immersions in a whirlpool. The SPF is then measured. While this
"standard" test procedure is effective for testing the water
resistance of the sunscreens of the prior art, it cannot be used to
test "wet-appliable" sunscreens, as part of the test procedure
involves allowing the sunscreen to dry for a twenty minute
period.
[0071] The test product is then applied to the participants while
they are in the hot room. A control product (8% Homosalate, SPF 4)
is evaluated via the same protocol. Their SPFs were then measured.
The Homosalate had an average measured SPF of 4.78 (SPF=3.71 to
5.85 with a 95% confidence level), while the sunscreen of the
present invention had an average measured SPF of 18.54 (SPF=18.14
to 18.94 with a 95% confidence level).
[0072] This particular test illustrated the unexpected result that
the SPF 15 sunscreen of the present invention had an increased SPF
value when the sunscreen was applied to a wet subject.
[0073] As will be obvious to those skilled in the testing art,
other procedures wherein panelists are engaged in sweat producing
activities, such as exercise (i.e., walking on a treadmill), could
be used to produce sweat on a test subject. Similarly, other acts,
such as spraying a panelist with a saline solution which has been
heated, as desired, to a known temperature can be used to simulate
sweating. All such procedures are considered to be within the scope
of the present invention, as its purpose is to simulate
sweating.
Test III (Underwater Procedure)
[0074] Similar to the sweat test procedure of Test II, a test
procedure to simulate a person applying sunscreen immediately after
having been bathing is also within the scope of the present
inventive testing procedures. Again, while a preferred embodiment
is disclosed, it is considered to be within the scope of the
present invention to wet a panelist by any appropriate means,
including submerging them or spraying them. In the preferred
embodiment of the procedure for testing the efficacy of a sunscreen
on a person who had been bathing, panelists are submerged in a
whirlpool, and while they are underwater the test product is
applied. A control product (8% Homosalate, SPF 4) is evaluated via
the same protocol. Their SPFs were then measured. The Homosalate
had an average measured SPF of 4.40 (SPF=3.72 to 5.08 with a 95%
confidence level), while the sunscreen of the present invention had
an average measured SPF of 17.92 (SPF=15.89 to 19.95 with a 95%
confidence level).
[0075] This particular test further illustrated the unexpected
result that the protection provided by the SPF 15 sunscreen of the
present invention actually increased when the sunscreen was applied
to a subject who was under water.
Test IV (Mist Procedure)
[0076] The test sites on the panelists are misted with water. A 0.1
g portion of test material is applied to the moistened 5.times.10
cm test site and spread evenly over the site using a fingercot.
This delivers a test film of 2 mg/cm.sup.2. Immediately after test
product application, the test site is divided into subsites which
are used for a defined serial UV light exposure. A control product
(8% Homosalate, SPF 4) is evaluated via the same protocol. Their
SPFs were then measured. The Homosalate had an average measured SPF
of 4.40 (SPF=3.72 to 5.08 with a 95% confidence level), while the
sunscreen of the present invention had an average measured SPF of
18.66 (SPF=18.55 to 18.77 with a 95% confidence level).
[0077] This particular test again illustrated the unexpected result
that the protection provided by the SPF 15 sunscreen of the present
invention increased when the sunscreen was applied to a wet
subject.
Test V (Instant Protection)
[0078] A sufficient number of test sites are outlined on the
subject's back between the sapulae and the beltline, lateral to the
midline, with a surgical marking pen. These areas are designated
for the Test material(s) or Standard, with an adjacent site
designated for a concurrent MED determination (unprotected
control). A 0.1 ml or 0.1 g portion of Test material(s) or
Standard, is applied to the appropriate 5.times.10 cm test site and
spread evenly over the site using a fingercot. This delivers a test
film of 2 mg/cm.sup.2. Immediately after test product application,
the test site is divided into subsites which are used for a defined
serial UV light exposure. A control product (8% Homosalate, SPF 4)
is evaluated via the same protocol. Their SPFs were then measured.
The Homosalate had an average measured SPF of 5.26 (SPF=4.54 to
5.98 with a 95% confidence level), while the sunscreen of the
present invention had an average measured SPF of 16.50 (SPF=13.95
to 19.05 with a 95% confidence level).
[0079] The sunscreens of the present invention provide
instantaneous protection, as confirmed by the test procedure
discussed herein. Those skilled in the art will recognize that
compared to the standard FDA approved test, as set forth in the
so-called "tentative final monograph", in which a waiting period
(drying time) of 20 minutes following application of a sunscreen is
used prior to testing, anything less than a 20 minute drying time
to achieve full SPF protection represents an improvement in
protection to the user. Therefore, the intent of the present
inventive test procedure is to substitute a time of less than 20
minutes, and preferably no time, between application and testing.
Accordingly, it is considered to be within the scope of the present
inventive test procedure to wait for less than 20 minutes between
application and testing. In particular, any time of 10 minutes or
less would be considered to be within the preferred range of
waiting time.
Test VI (15 Minute Drying)
[0080] A sufficient number of test sites are outlined on the
subject's back between the sapulae and the beltline, lateral to the
midline, with a surgical marking pen. These areas are designated
for the Test material(s) or Standard, with an adjacent site
designated for a concurrent MED determination (unprotected
control). A 0.1 ml or 0.1 g portion of Test material(s) or
Standard, is applied to the appropriate 5.times.10 cm test site and
spread evenly over the site using a fingercot. This delivers a test
film of 2 mg/cm.sup.2. At least 15 minutes after product
application, the test site is divided into subsites which are used
for a defined serial UV light exposure. A control product (8%
Homosalate, SPF 4) is evaluated via the same protocol. Their SPFs
were then measured. The Homosalate had an average measured SPF of
5.26 (SPF=4.54 to 5.98 with a 95% confidence level), while the
sunscreen of the present invention had an average measured SPF of
17.26 (SPF=14.70 to 19.82 with a 95% confidence level).
* * * * *