How SPF Products Are Evaluated for Their Effectiveness

As a cosmetics testing lab, AMA Laboratories, Inc. offers a range of services to businesses seeking FDA approval. One of the tests that AMA Laboratories, Inc. administers is for products containing SPF, mainly through in vivo testing.

In general, SPF quality is determined through in vivo and in vitro testing. The ability for SPF to effectively work is based on a few factors. The first factor is related to the product’s ingredients and the SPF formula used. Other factors include the users’ skin type, the way they apply the product, and the amount of UV ray exposure.

In vivo testing requires that the number of subjects is at least ten participants. Clinicians apply a certain amount of sunscreen on the volunteers’ back, allowing the product to dry for 15 minutes. After the product is dried, researchers will administer doses of UV radiation to the area. The clinicians will also apply a series of doses to areas that are not protected by the SPF product.

Anywhere between 16 and 24 hours later, clinicians will return to see how the product fared. This trial varies with some labs placing the product on various parts of the body. The clinicians determine SPF by looking at the lowest dose of UV that causes mild sunburn with the product divided by the lowest dose of UV that caused mild sunburn without the product.

In vitro testing, conversely, involves using artificial substrates that mimic human skin types. These substrates, in conjunction with computer mathematical models, predict effectiveness based on the absorption of active ingredients. Currently, there is no standard for measuring SPF levels using this method.

Increasing Bioefficacy in Cosmetic Formulations

In addition to claims substantiation testing, AMA Laboratories Inc. performs efficacy and safety testing on a variety of consumer products. AMA Laboratories Inc. works with many clients in the cosmetics and personal care sector, helping them to establish the best formulations to achieve their goals.

A primary driver of the claims made about cosmetics is bio-active compounds in the formulation. Therefore, it’s crucial to make those compounds as efficacious as possible. The first step to maximizing efficacy is to understand the biological mechanism that the product is trying to modify. Skin lightening, for instance, will be closely tied to melanin synthesis.

Once the mechanism is identified, you can move on to finding the best ingredients to act on that mechanism. It will probably take substantial experimentation to find the right ingredient that will be best suited for every process in the mechanism.

Then, once all the most effective ingredients are identified, you’ll need to make sure there’s a stable formulation possible with their combination. This will involve considerable testing to find a formulation with an acceptable shelf life. This can be accelerated through various means.

Once that work is done, you can move on to the final determination which, of course, involves clinical testing. If you’ve done the due diligence correctly throughout the process this final stage shouldn’t be a problem, and the product should perform as intended.

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