The Purpose of Sunscreen
Sunscreens are topically applied products that protect the skin from the sun's ultraviolet (UV) Radiation. Sunscreens work by incorporating active ingredients that remain on the surface of the skin that absorb, scatter, or reflect UV Radiation before it reaches the skin. This filtering out of UV Rays helps reduce the risk of skin cancer, premature aging and also help prevent sunburn.
The FDA & Sunscreen Products
Although sunscreen has been around since the 1940's, it has only been regulated by the FDA since 1978. Sunscreens are a cosmetic, but they are also technically a drug as they contain active drug ingredients in order to ensure adequate protection benefits. Sunscreens are regulated by the FDA as Over-The-Counter (OTC) drugs. A sunscreen product must be both safe and effective, as well as comply with FDA requirements. Individual Sunscreen active ingredients must be reviewed by the FDA and only those that are on the FDA's monograph approved list may be used in Sunscreen products to be marketed in the United States. The two most common active ingredients that are approved by the FDA and used in sunscreen to achieve protection benefits are Zinc Oxide and Titanium Dioxide.
Requirements
The effectiveness of a sunscreen really depends on a few factors such as Sun Protection Factor (SPF) value, if it provides broad spectrum protection, water resistance, and if it is used as directed.
A sunscreen product must have a Drug Facts panel somewhere on the packaging that is legible and can easily be read. The Drug Facts statement must include the active ingredients used in the formula, product Cautions and Warnings, Directions for Use, and the full ingredients list.
Testing
Launching a sunscreen is more than just getting a product formulated. In order to launch a sunscreen, there are FDA required tests that you will have to have conducted in order to be able to market your product in the US. You will need to prove to the FDA that your product is safe and effective. These tests can only be conducted after your product has been through the final approval stage of formulation.
Stability Testing
A Sunscreen product must undergo a stability test. The stability test determines the shelf life of the product. A product that is in the process of expiring undergoes several changes including: color, odor / fragrance, pH value, viscosity, texture, flow, and emulsion stability (signs of separation). Using an expired sunscreen will not protect the skin from the sun as active ingredients can loose their potency over time.
You can read about Stability Testing in our previous blog post to learn more about this test.
SPF Monograph Test
The SPF Monograph Test is a clinical test conducted to determine that the SPF value stated on the packaging of the product is actually the level of Sun Protection that the product provides when used properly. SPF Values can range from 30 to 100. Determining the product's SPF is a safety measure, if you are applying a product that claims it has a value of SPF 90, but it really only contains a level of 30, you will not take precautions necessary to prevent sunburn. Applying a sunscreen with an inaccurate SPF value leads you to believe you have more sun protection that you actually do.
US Broad Spectrum Critical Wavelength Test for Broad Spectrum Claim
A sunscreen can be labeled Broad Spectrum if it provides UV protection across both UVB and UVA wavelength ranges. The Broad Spectrum test is an in-vitro laboratory test that measures a sunscreen product's transmittance/absorbance of ultraviolet (UV) radiation across both the UVA and UVB regions of the spectrum. This test is also referred to as the Critical Wavelength Test, and in order to pass this test the sunscreen must demonstrate that it has a critical wavelength of 370 nanometers or greater. 370 Nanometers is a requirement set by the FDA because this measure ensures that sunscreen products meeting this value provide a significant amount of broad spectrum protection.
There are other tests that can be conducted for sunscreens, but these are the most common associated with launching a new sun care product. If you are thinking about launching any kind of sun care product, you will want to make sure that the product is created by a laboratory that has had experience in working with sunscreens and active ingredients. An experienced chemist will be able to formulate a sun care product that meets all of the requirements of the FDA and is effective and safe for use.