I contacted Antaria and Dow Chemical
and received the following comments:
• Since 2007 Antaria has represented
ZinClear-IM as a porous micron-sized
zinc oxide particle. However, the defini-
tions and working definitions of“nanopar-
ticle” and “nanomaterial” have evolved
since ZinClear-IM was commercialized.
ZinClear-IM is not a nanoparticle—the
particles are micron-sized. Under the re-
cently emerging definitions of“nanomate-
rial,” ZinClear-IM would be a nanomaterial
because of its porous structure, which is
on a nano scale. The current EU definition
of a nanoparticle is “non-soluble or bio-
persistent substances, produced intention-
ally, characterized by one or more external
dimensions or by an internal structure, on
a scale of 1 to 100 nm” (Definition from
Regulation (EC) N° 1223/2009 of the
European Parliament and of the Council
of 30 November 2009 relative to cosmet-
ics, published in the Official Journal of the
European Union of 22/12/2009). This type
of ingredient is prohibited by this standard.
Antaria makes only one substantial
commercial claim in respect to ZinClear
IM—its exceptional transparency in cos-
metic use. The fact that this transparency is
delivered in a micron-sized particle is the
central triumph in its innovation. Antaria
has been careful to never make any com-
mercial claim that this micron size im-
proves product safety.
For those customers that, for one
reason or another, are worried about
nanoparticles: Antaria confirms the
ZinClear-IM particle is a micron-sized
particle as measured by laser light scattering, well above the size that is considered
a “nanoparticle.” These measurements
indicate there are very few free nanoparticles in ZinClear-IM dispersions.
Irrespective of the above concerns,
Antaria is having difficulty in fathoming
why the structure of ZinClear-IM is such as
issue. Whether nanoparticulate or not, zinc
oxide is considered completely safe for per-
sonal care use by the FDA and other inter-
national regulators. No new evidence has
been shown that there is any hazard what-
soever relating to zinc oxide in any form.
As I have mentioned in earlier columns,
inorganic particulates are gaining acceptance
in our industry. Considerable knowledge has
been attained by
chemists, formula-
tors, manufacturers
and most notably
by consumers and
end users as to
their attributes and
value in suncare
products. The two
cases presented in
this column dem-
onstrate the depth
of knowledge that
consumers have
attained but also
the serious conse-
quences that can be
caused by the rapid
dissemination of information in our industry.
Addressing consumer concerns head-on is
prudent but also fraught with pitfalls if not
handled wisely.
I rarely comment on internet columns,
but a series of articles written by a young
blogger named John Su are worth noting.
This aspiring dermatologist wrote four parts
of a presumably five-part series on inorganic sunscreens that were excellent despite
a few errors and the scientific incompleteness of his treatises. He addressed the irritation potential, aesthetics, photostability,
photoreactivity, permeability, toxicity, level
of protection and practicality of inorganic
sunscreens as compared to the so-called organic sunscreens. 7 It is well worth reading.
Another publication that is well written
is the Melanoma letter which is issued by
the Skin Cancer Foundation. 8 In its Summer
2012 issue, three articles were published The
first is entitled “Regular Use of Sunscreen
Can Reduce Melanoma Risk”by Adele Green
and Gail Williams, the second “Challenges
in Making an Effective Sunscreen” by Steve
Wang and Judy Hu and the third“Everyday
and High-UPF Sun-Protective Clothing” by
Peter Gies and Alan McLennan.
In conclusion, regulations systematize
the expectations for our industry. They hold
manufacturers to agreed upon standards
so that the consumer base can rest assured.
Without such standardization, constant use
of the legal system seems the only retreat
and the gossip mill guides consumer confidence. To save us needless misspent energy
and other dangers, we prevail upon the
FDA to standardize and regulate. •
References:
1. http://www.manatt.com
2. http://www.manatt.com/uploadedFiles/
Content/4_News_and_Events/Newsletters/
AdvertisingLaw@manatt/Brody
3. www.cosmeticsDesign.com/USA December
21,2011
4. www.FOE.org.au/articles
5. US Patent 2010/0310871 (Antaria)
6. ISO/TS 27687:2008
7. www.future derm.com/2012/09/06/Are
Inorganic sunscreens better than organic ones.
8. www.skincancer.org, The Melanoma Letter,
Summer 2012.
