In-Vivo Testing

Sunlight, a source of life and energy, creates major health challenges like sunburn, pigmentation, wrinkles, dermatitis, and ageing.  Eurofins CRL offers a full spectrum of human subject based research to meet a wide range of regulatory guidelines required for the world’s markets.

Static SPF Testing

SPF measurement is performed on a panel of at least 10 human adult volunteer test subjects with selected skin types to demonstrate the potential for sun-burning skin reactions. The test panel is selected from subjects who do not have any history of sensitivity to skin product ingredients and who have an appropriate health history.

  • FDA

    The FDA (1978) was the first in vivo method created for the evaluation of SPF on informed human volunteers.   The 2011 sunscreen final rule states that sunscreen products are considered OTC (Over the Counter) drugs and may be marketed without an approved new drug application (NDA) or abbreviated new drug application (ANDA). However, a new ruling is in progress and Eurofins CRL is keeping up-to-date with current proceedings.

  • ISO 24444

    This ISO testing specifies a method for the in vivo determination of the sun protection factor (SPF) of sunscreen products. This International Standard is applicable to products that contain components able to absorb, reflect or scatter ultraviolet (UV) rays and which are intended to be placed in contact with human skin.   ISO24444:2019 was published in December of 2019 and Eurofins CRL is incorporating the regulatory changes into its current protocols.

Water Resistant Testing

The water resistance test indicates that a sunscreen product’s labeled SPF protection is retained for a certain period of time after immersion in circulating water. The determination of a water resistant claim is performed by standardized and reproducible methods under the FDA, ISO, and AS/NZS guidelines.  Types of water resistance testing available are as follows:

FDA 40min/80min

ISO 40min/80min

AS/NZS 40min/2hr/4hr

Sweat Resistant

Similar to water resistance SPF testing, sweat resistance testing takes place in our custom built environmentally controlled chamber.  Here we can adapt various means of activity to induce sweating to evaluate the “staying power” of a particular SPF formulation under various exercise and environmental conditions.

Wet Skin Application

Testing is conducted by lightly spraying water onto the test site prior to test product applications.  UV exposures are then administered to the test products per the requested testing methodology, followed by an SPF or UVAPF value determination.  This application technique can be added to all FDA, ISO, and AS/NZS testing methods.

Sand Resistance

Testing is conducted by applying and removing sand from test products in order to simulate the action of being on the beach.  UV exposures are then administered to the test products per the requested testing methodology, followed by an SPF or UVAPF value determination.  This resistance testing can be added to all FDA, ISO, and AS/NZS testing methods.