U.S. Patent No. 5,879,703
Dermazone sunscreens have
undergone
the following toxicological and sensitivity tests:
Primary Skin Irritation
– testing conducted for a 24-hour period and evaluates the acute
irritation of material applied topically onto the skin. The primary
indicator of irritancy in these tests is the degree of redness or
erythema.
Photoallergenic Potential
– testing evaluates the photoallergenic potential of test materials
following UV-A irradiation on human subjects. The degree of erythema
is evaluated 24 hours and 48 hours after application of the test material
following the UV-A irradiation and occlusion for twenty-four hours
prior to the first evaluation of the test site. This evaluates the
likelihood of allergic reactions to test materials applied topically
onto intact human skin after exposure to UV-A radiation.
Phototoxic Potential
– testing evaluates the potential of test material to elicit
topical toxic effects after application of test materials onto human
subjects. The degree of erythema is evaluated immediately following
at twenty-four and forty-eight hours and one week after a 24 hour
test period in which the test material was placed onto the skin, the
skin was UV-A irradiated and the occluded under a dressing material
for 24 hours.
Sun Protection Factor
– testing evaluates the ability of test materials to prevent
redness on human skin after a topical application of test material
followed by UV radiation of one minimal dose. Subjects are evaluated
24 hours after irradiation.
Waterproof Determination
– testing evaluates the ability of test materials to remain
on the skin and resist removal during water immersion. This test is
done in conjunction with SPF testing on human subjects. After topical
application of test materials, and allowing 30 minutes for the skin
to dry, the test site is immersed in water for 20 minutes and rested
out of water for 20 minutes. The test site is subjected to four cycles
of immersion and drying prior to UV irradiation. The test site is
then evaluated 24 hours later to determine the degree of erythema
and hence the SPF number.
Extended Waterproof
– testing is used to evaluate the ability of test materials
to remain substantially on the skin after 8 hours of repeated exposure
to water. This testing is conducted on human subjects and is identical
to the waterproof testing with the exception that the test site undergoes
repeated cycles of water immersion and drying for full 8 hours prior
to UV irradiation.
These studies have shown that our sunscreen products are non-toxic,
non-irritating, and maintain their waterproof properties for up to
eight hours. Neither the SPF 15 nor the SPF 30 has shown any comedogenicity.
All the ingredients in the sunscreens are all very well known with
a high safety profile.
Most sunscreens start with a high level of protection, which diminishes
over time; their properties held in the skin by oils, polymers or
waxes, which can clog. Dermazone sunscreens, because of the penetration
of the actives into the stratum via the liposome, do not contain these
pore-clogging materials. In addition, Dermazone sunscreens maintain
their SPF factor throughout the eight-hour period. They also provide
an optimal moisturizing effect to the skin because of their water
content, which is why we refer to them as moisturizing sunscreens.
DERMAZONE’S sunscreens have been the sunscreen
of choice for the Olympic Swiss Ski Team for 5 years.
DERMAZONE’S sunscreens have been the sunscreen
of choice for Physicians around the world for over 12 years.