| Regulatory reference: | According to ASTM ASTM E1173 – 15. |
| Claim: | Effectiveness of alcohol swabs |
| Application field: | Finished products. |
| Description of the test: | The test method is designed to measure the reduction of the microflora of the skin for Preinjection Skin Preparations. This test method is conducted on human subjects selected randomly from a group of subjects who, after refraining voluntarily from using topical and oral antimicrobials for at least two weeks (14 days), exhibit acceptably high normal flora counts on the skin sites to be used in testing. |
| Regulatory reference: | According to ASTM E2315 – 16. |
| Claim: | Kills 99.99% of germs |
| Application field: | Finished products. |
| Description of the test: | Antimicrobial activity of specific materials is measured with this technique by measuring the changes in a population of aerobic microorganisms within a specified sampling time. This test can be used in particular for the hand sanitizers with the claim “kills 99.99% of germs”. |
| Regulatory reference: | ISO 24444:2019. |
| Claim: | Salt water resistant |
| Application field: | Finished sunscreen products. |
| Description of the test: | Test performed on 10 volunteers, by comparison of pre-wash and post-wash SPF. The treatment includes two washes, one in salt water, performed by irroration with 1M NaCl solution by a pressureless drop shower, and one in fresh water. If the reduction of protection is greater than than 50% the product isn’t considered to be “Salt Water Resistant”. |
| Regulatory reference: | ISO 24444:2019. |
| Claim: | Sand resistant |
| Application field: | Finished products. |
| Description of the test: | In vivo test on 10 subjects. Comparison between SPF of sun product and the reduction on protection cause of double sand static contact of 20 minutes in this sequence: contact, techanical cleaning, contact and final mechanical cleaning before the exposure to the solar multiport simulator. If the reduction of protection is mayor than 50% the product isn’t “sand resistant”. |
| Regulatory reference: | Proprietary method |
| Claim: | Antioxidant and Anti-pollution |
| Application field: | Raw materials and finished products. |
| Description of the test: | In vitro test for the evaluation of the protective effect against air pollution. The purpose of this test is to evaluate the efficacy of the sample in reducing ROS release in response to a mix of heavy metals and atmospheric dust particulate in a skin-derived cell model. |
| Regulatory reference: | FDA “guidelines for effectiveness testing of antiperspirant drug products”, CFR 21 protocol |
| Claim: | Anti-perspirant activity |
| Application field: | Active ingredients, mixtures or finished products. |
| Description of the test: | The test is carried out on 30 volunteers. Pre-treatment cycle of 17 days, treatment cycle with the anti-perspiration product for 4 days, exposure in acclimatized room for the times and in the conditions laid down according to the FDA normative at T 24 hours subsequently to the interruption of the anti-perspiration treatment. Gravimetrical reading with analytical balance at T 24 hours of the treated side against the high non-treated armpit. Report in English with Wilkoxon method statistical analysis. |
| Regulatory reference: | Proprietary method based on ISO 24444:2019. |
| Claim: | SPF Sun Protection Factor |
| Application field: | Sunscreen creams, sticks and cosmetic products. |
| Description of the test: | Preliminary screening of the sun protection factor, UVA/SPF ratio and critical wavelength of a sunscreen formula. |
| Regulatory reference: | ISO 24444:2019 and Australian AS/NZS 2604:2012 protocol |
| Claim: | SPF Sun Protection Factor |
| Application field: | Sunscreen creams, sticks and cosmetic products. |
| Description of the test: | Determination of the sun protection factor (SPF) on healthy volunteer through controlled irradiation and measurement of the erythemal response. |
| Regulatory reference: | Proprietary method based on ISO 24443:2012. |
| Claim: | Water resistant |
| Application field: | Sunscreen creams, sticks and cosmetic products. |
| Description of the test: | Determination of the percentage of water resistance of a sunscreen product on PMMA plates with measurements before and after washes in controlled conditions. The preliminary test requires confirmation through in vivo tests. |
| Regulatory reference: | ISO 16217 and ISO 18861 |
| Claim: | Water resistant or Highly water resistant |
| Application field: | Sunscreen creams, sticks and cosmetic products. |
| Description of the test: | Determination of the percentage of persistence of the Sun Protection Factor (SPF) on healthy volunteers after washing in controlled conditions. |