burnd Q&A | Episode 1

1. How are skin care products regulated?

In the United States, skin care products are regulated by the Food and Drug Administration. Generally, any skin care product sold without a prescription falls into one of two categories: over-the-counter drugs or cosmetics.

-Over-the-counter drugs contain active ingredients that are designed to treat or prevent a condition. Common examples include sunscreens, acne treatments, and anti-dandruff shampoos

-Cosmetics are products intended for cleansing, beautifying, or enhancing appearance, such as moisturizers, serums, and makeup

There are other specialized categories, such as fragrances, but the general regulatory framework remains the same. If a product contains a drug, defined as a substance intended to treat, prevent, or alter body function, it must follow over-the-counter drug regulations or require a prescription.

2. What are over-the-counter monographs and why do they matter?

Most over-the-counter skin care products are covered by over-the-counter monographs, which are detailed regulatory guidelines that specify:

-Approved active ingredients

-Allowed concentrations and formulations

-Required labeling and marketing claims

-Testing and safety standards

For example, the sunscreen monograph outlines which UV-blocking ingredients are permitted, the maximum concentrations allowed, how they must be labeled and what claims can be made. Because these rules are highly standardized, over-the-counter drug labels tend to look and sound very similar across brands.

Examples of over-the-counter monographs related to skin care include:

1. Sunscreens

2. Topical antifungal drugs

3. Acne treatments

4. Skin protectants, such as lotions for eczema and minor wounds

5. Antiperspirants

6. Wart removers

7. Corn and callus removers

8. Topical ear treatments

9. Dandruff, seborrheic dermatitis, and psoriasis treatments

10. Anticaries treatments, such as fluoride toothpaste