Product Safety and Compliance

At bioClarity LLC, we carefully test all of our cosmetic products to ensure your safety and safe use. We use the most rigorous testing methodologies available to ensure that our products meet all safety standards as required by the FDA.

Every person reacts differently to the use of any cosmetic product and although our products are rigorously tested for safety, it is possible that a person may have an allergic or contact dermatitis reaction when using our products.

We recommend that you Patch Test our products before use to ensure that your skin tolerates use of our products. To Patch Test, apply a small amount of product to a specific area of your body, such as a cheek and wait 10 to 15 minutes to see if you experience any persistent redness, stinging, burning, itching, edema or welping. If you experience any of these symptoms, cease using the product.

The FDA defines two different reactions to the use of cosmetic products:

Adverse Event: A reaction after using a cosmetic, such as a rash, redness, burn, hair loss, headache, infection, illness or any other unexpected reaction, whether or not it required medical treatment.

Serious Adverse Event: an adverse event that

• (A) results in:

o death;

o a life-threatening experience;

o inpatient hospitalization;

o a persistent or significant disability or incapacity;

o a congenital anomaly or birth defect;

o an infection; or

o significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or

persistent or significant alteration of appearance), other than as intended under conditions of use that are customary or usual; or

• (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described in (A) above.

If you think you have suffered from an adverse event due to our products please e-mail us at adverseevents@skylinebeautygroup.com allowing us to investigate further and report to the FDA.