Why don't my Lip Balms contain SPF?

The short answer is: legally they can't. The long answer is...

There are three main types of products that are considered to be part of the "bath and body" industry: Soap, Cosmetics, Drugs (including over the counter).

 Is it a soap, a cosmetic, or a drug?

FDA interprets the term "soap" to apply only when

• the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
• the product is labeled, sold, and represented solely as soap

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA.

If a product

• consists of detergents, or
• primarily of alkali salts of fatty acids, and
• is intended not only for cleansing but also for other cosmetic uses,

it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive or by acting as a deodorant.

If a product

• consists of detergents, or
• primarily of alkali salts of fatty acids, and
• is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body,

it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and skin lighteners.

And more confusingly: If a product

• is intended solely for cleansing the human body,
• has the characteristics consumers generally associate with soap, and
• does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

How registration requirements are different
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations. As its name indicates, this program is voluntary. The FD&C Act does not require cosmetic firms to register their establishments or list their product formulations with FDA. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA.

How labeling requirements are different
A cosmetic product must be labeled according to cosmetic labeling regulations. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients."

I get asked quite a bit if my lip balms contain an SPF. They don't and never will. It is because sunscreen is considered an Over-The-Counter Drug by the FDA. The safety of Sunscreen Gels, Creams, and Liquids is established by selection of ingredients that are safe and suitable for this purpose. In addition, these products are screened for photoirritancy, photosensitization, and photomutagenicity. Product safety is also established though strict adherence to the principles of Quality Assurance and Good Manufacturing Practices. This includes testing the compatibility of the product with packaging as well as shelf-life stability. Sunscreens are regulated by the Food and Drug Administration as Over-The-Counter (OTC) drugs. As such, they must be shown to be safe and effective and the active ingredients must be approved by FDA.

The legalities and requirements of a company my size to make any drug (OTC or otherwise) is beyond my capabilities (and desires). Unfortunately there are some hand-crafters who do indeed claim to make a sunscreen product, this makes it more confusing for all consumers. Either these companies don't understand the laws, or they choose to ignore them. I may not personally even agree with the current structure of the law, but once I understand it, then it is my responsibility to follow it to the letter and run my business in both a legal and ethical way.