Active ingredient, impurity and finished product testing for sunscreens, hand sanitizers, acne treatments, antiperspirants and other over-the-counter drugs
In the US, sunscreen, hand sanitizer, acne gels, antiperspirant, fluoride toothpaste and pain-relief creams are over-the-counter drugs, not cosmetics. Each one has to contain its active ingredient at the amount on the label, stay inside the limits its monograph sets, and stay in specification until its expiration date. We test finished OTC products and the raw materials that go into them for active content, impurities, microbial quality and the physical properties in your specification.
Testing is quoted per product.
Zinc oxide and titanium dioxide content. Organic UV filters such as avobenzone, octocrylene, homosalate, octisalate and oxybenzone. Preservatives, microbial limits and stability.
Ethanol or isopropyl alcohol content, plus methanol and the other impurities FDA limits in hand sanitizers, such as benzene, acetaldehyde and acetal.
Benzoyl peroxide, salicylic acid, hydrocortisone and other topical actives, measured against the label claim.
Aluminum and zirconium content in antiperspirant actives and finished products.
Fluoride in toothpaste and mouth rinse.
Menthol, camphor, methyl salicylate, lidocaine and similar actives in creams, gels, roll-ons and patches.
Any OTC product can also be tested for microbial limits (USP 61 and 62), Burkholderia cepacia complex (USP 60), preservative efficacy (USP 51), pH, viscosity, specific gravity, heavy metals and residual solvents.
Most OTC products are sold under an FDA monograph, which sets the active ingredients you can use, how much of each, and what the label has to say. Testing a batch tells you the active is there at the amount on the label, usually within 90 to 110 percent unless your monograph or specification says otherwise, and that impurities and degradation products are under their limits. If a product has more than one active, each one is measured.
Testing an active ingredient before it goes into production is cheaper than finding a problem in a finished batch. We can confirm the identity and assay of incoming actives and check them for impurities and residual solvents, so you can qualify a supplier and verify the certificate that comes with each lot.
OTC drugs need an expiration date backed by stability data. See pharmaceutical stability testing for studies at ICH conditions, photostability and forced degradation.
Tell us the product, its actives and the tests you need, or send your finished product specification.
We quote each test and confirm the sample amount.
Finished units in their final package, or raw material in a sealed container.
You get a report with each result against your specification.
It depends on the claim. A moisturizer is a cosmetic, but a moisturizer with SPF is a sunscreen drug. Products that claim to treat acne, stop sweating, prevent cavities, kill germs or relieve pain are drugs.
No. SPF and broad-spectrum testing are done on people or with a specific in vitro method under FDA’s sunscreen rules, and aren’t part of this page. We test the amount of each UV filter in the product.
At a minimum, identity and amount of each active ingredient and the other tests in your finished product specification. Many products also need microbial limits.
It depends on the tests. Two or three finished units cover most label claim testing. We confirm the amount with your quote.
Yes. We test alcohol content and impurities such as methanol, benzene, acetaldehyde and acetal.
Yes. We can test actives and other ingredients for identity, assay, impurities and residual solvents before they go into production.
Tell us about your product and we’ll send back a quote. You can also email [email protected].
