Sunscreens, typically a lotion, spray, gel or other topical
product, absorbs or reflects some of the sun's ultraviolet (UV) radiation on
the skin exposed to sunlight. Sunscreen ingredients help to prevent sunburn
and may reduce the chance of premature skin aging, skin cancer, and other
harmful effects due to the sun.
Consequently, a product that includes the term “sunscreen” in its labeling or in any other way represents or suggests that it is intended to prevent, mitigate or treat the effects of solar radiation comes within the definition of a drug according to the the US Food and Drug Administration (FDA).
The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current Good Manufacturing Practice guidelines.
FDA Allowable UV FiltersThere are two types of sunscreens: organic (or chemical) and inorganic (or physical) sunscreens. Organic sunscreens are usually aromatic molecules conjugated with carbonyl groups which allow the molecule to absorb high-energy, skin-damaging UV rays and release the energy as lower-energy harmless rays.
Inorganic sunscreens such as titanium dioxide and zinc oxide do not absorb but reflect UV rays. Micronized titanium dioxide and zinc oxide, however, also have the ability to absorb UV rays. Inorganic sunscreens reflect primarily UVB rays. However, the larger the particle size the more UVA protection is also achieved.
|Sunscreen||UV Protection||Allowed Use Level USA (alone/combined)|
|p-Aminobenzoic acid||UVB||15% / 5-15%|
|Phenylbenzimidazole sulfonic acid (Ensulizole)||UVB||4% / 1-4%|
|Cinoxate||UVB||3% / 1-3%|
|Dioxybenzone (benzophenone-8)||UVB/UVA||3% / 3%|
|Oxybenzone (benzophenone-3)||UVB/UVA||6% / 2-6%|
|Homosalate||UVB||15% / 4-15%|
|Menthyl anthranilate||UVA||5% / 3-5%|
|Octocrylene||UVB||10% / 7-10%|
|Octyl methoxycinnamate||UVB||10% / 2-7.5%|
|Octyl salicylate||UVB||5% / 3-5%|
|Sulisobenzone (benzophenone-4)||UVB/UVA||10% / 5-10%|
|Titanium dioxide||UVB||25% / 2-25%|
|Zinc oxide||UVB/UVA||25% / 2-25%|
Checklist For Selling Sunscreen Products
- Manufacturer has to be a registered drug establishment with the FDA and comply with cGMP regulations for drug manufacturing.
- Labeling has to comply with labeling requirements for OTC drugs, including Drug Facts format labeling.
- Final product has to be listed with the FDA's NDC database (National Drug Code Directory) by the manufacturer or the distributor.
- Product has to have efficacy testing on the formula to show that it delivers the SPF that the label claims. Additional tests are warranted if you want to make broad spectrum protection claims. Typically, SPF testing is performed by a certified laboratory.
- Safety testing to prove that the product is safe, usually a repeated insult patch test (RIPT) on humans volunteer subjects needs to be done.
- Stability testing will have to be conducted, including periodic assays of the active ingredients, to show that the active ingredients don't deteriorate over time.