Newsletter no. 02/2012 DETERMINATION OF THE SOLAR PROTECTION FACTOR (FDA METHOD Final Rule 18th June 2012)

FDA method is the first official method for the determination of Sun Protection Factor (SPF). First published in the Federal Register in 1978, it was revised in 1993 and then 1999. In compliance with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts Final rule, The Food and Drug Administration (FDA) is issuing the Final Rule to address labeling and effectiveness testing for over-the-counter (OTC) sunscreen products. The Final Rule will be effective on June 18, 2012. As of that date our company will carry out in vitro and in vivo tests to determine the sun protection factor accordingly. NOTE: The Food and Drug Administration (FDA) is delaying the compliance dates for the Final Rule that published in the Federal Register of June 17, 2011 (76 FR 35620) because information received after publication of the 2011 final rule indicates that full implementation of the 2011 final rule’s requirements for all affected products will require an additional 6 months. Technical Department Manager Claudio Angelinetta In vitro test Responsible Eliana Regola

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