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letry & Fragrance Association) Proposition to FDA, 1997, which must be considered an impor-
tant contribution, because using Labsphere Ultraviolet Transmittance Analyzer, it is possible to
obtain Oc or CW (Critical Wavelength), a new relative magnitude that provides quantitative
photoprotective information on UV-A; in vitro SPF measurements, and UV-A/UV-B attenuation
ratio in accordance with the British Guidance.

The conceptual skin photodamage prevention and treatment evolution, present and future, is
considered a matter of great pharmaceutical clinical interest. The FDA Federal Register, 1978,
based upon physicochemical evidence, ruled that sunscreens with SPF 15 were sufficient to of-
fer full protection against sun damage during all a summer day without clouds, however the
FDA Tentative Final Rule, 1993, accepting that there were special use conditions and photo-
dermatoses requiring higher sun protection factors, raised maximum SPF, from 15 to 30. In the
same Federal Register, the Agency, issued a new photoprotective attribute, the B.S.P. (Broad
Spectrum Protection), qualifying a sunscreen with the feature of conferring ultraviolet attenua-
tion on UV-B (290-320nm) plus UV-A (320-400 nm), being the first time that a Governmental
Guidance, recognized the importance that a sunscreen had attenuation on UV-A range.

It is assigned a large theoretical and practical significance, when in USA was demonstrated
and made public in 1997-1998, that 80-90% sunscreen didn´t fulfill the CTFA Proposition to
FDA requirements, because their Oc (CW) d 370nm and also stated, that it was necessary to
avoid the uncontrollable called “SPFs horse race”, without correspondence on UV-A (320-
400nm) increased attenuation, revealing that the American population was not appropriately
protected with the products available in the market. Next, it is examined in depth, the FDA Final
Rule, May 21 1999, in order to overcome the situation previously denounced, using SPFs only,
ruling three new categories based merely on sunburn protection levels, doing omission on quan-
titative UV-A (320-400 nm) protection, but maintaining B.S.P. attribute, tried to answer to the
Congress mandatory issue, that gave origin to Final Rule. In addition, the Agency, as a means of
controlling the called “SPF horse race”, ruled that sunscreens with SPF higher than 30, should
be labeled SPF 30+ or SPF 30 Plus, and that the product that after May 21, 2001, had not made
the labeling substitution, will cause the product to be misbranded. Testing omission, received
severe critics from CTFA and from scientific community, what determined a first postponement
to December 31 2002, followed of a second one, until not before 2005, so the FDA could study
new SPF testing for sunscreens with SPF higher than 30 and new methodology for UV-A pro-
tection factor assessment, what is a clear evidence of the importance that have sunscreens with
SPF higher than 30, of the attenuation on UV-A (320-400nm) range, and that sunscreens have
wide and balanced photoprotection all over ultraviolet range (200-400nm). The current Euro-
pean Community status is commented, because the day before to give this conference at Royal
National Academy of Pharmacy, Spain, the European Cosmetic, Toiletry and Perfumery Asso-
ciation, 40 years of COLIPA Commemoration held at Venice, Italy, scheduled two sessions: A
Fresh Look at UV-A Testing and COLIPA Recommendation on SPF Labeling.

In this paper, the conclusions are several. In first place, to appreciate the conceptual evolu-
tion that sunscreens have had throughout the latest twenty four years, from cosmetic to “OTC-
Drug Product”, to Drug strictly speaking, and from suntan to efficient sunscreens against differ-
ent kinds of skin photodamage.

To accept as a great achievement that SPF (Sun Protection Factor) testing is internationally
harmonized, but still remaining the necessity to develop new SPF testing for sunscreens with
SPFs higher than 30, due to the increasing demand of sunscreens with higher SPFs than 30.

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