Claim for OTC

Pre-injection swab test

Method for Evaluation of Preinjection Skin Preparations

 

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.
Posted in Effectiveness of alcohol swabs, Claim for OTC, Claim for medical devices

Time-Kill Test

Assessment of Antimicrobial Activity Using a Time-Kill Procedure

 

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”.
Posted in Kills 99.99% of germs, Claim for OTC, Claim for medical devices

Test of reduction of SPF caused by salt water

Regulatory reference: ISO 24444:2010 of 15/11/2010 and Colipa test method 2006 for the determination of the WATER RESISTANCE. Test performed according to modified COLIPA 2005 method
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”.
Posted in Sunscreens, Water resistant, Claim for OTC, Salt water resistant

Test of reduction of SPF caused by sand

Regulatory reference: ISO 24444:2010 of 15/11/2010 and Colipa test method 2006 for SPF.
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”.
Posted in Sunscreens, Sand resistant, Claim for OTC

In vitro test for the evaluation of the protective effect against air pollution

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.
Posted in Anti age, Sunscreens, Claim for OTC, Cosmetic raw materials, Antioxidant, Anti-pollution, Make up, Moisturizers, Claim for cosmetics

Anti-perspiration activity test

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.
Posted in Anti-perspirant, Anti-perspirant activity, Claim for OTC

Preliminary in vitro SPF determination

Regulatory reference: Proprietary method based on ISO 24444:2010
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.

 

Posted in Sunscreens, Claim for OTC, SPF Sun Protection Factor

In vivo determination of the sun protection factor (SPF)

Regulatory reference: ISO 24444:2010 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.
Posted in Sunscreens, Claim for OTC, SPF Sun Protection Factor

Preliminary in vitro water resistance test

Regulatory reference: Proprietary method based on COLIPA 2005 and 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.
Posted in Sunscreens, Water resistant, Claim for OTC

In vivo water resistance test

Regulatory reference: COLIPA 2005
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.
Posted in Sunscreens, Water resistant, Claim for OTC, Highly water resistant