Along with summer comes the beach, the sun, and naturally, sunscreen. The miracle cream that prevents everyone from that horribly burned skin after a wonderful day of fun in the sun. But what exactly are the regulations surrounding this cream? How is SPF regulated and maintained to guarantee protection for everyone’s skin?
The majority of sunscreens in the United States are marketed under the regulatory framework called the OTC Monograph system. Where the FDA reviews the active ingredients in sun protection products to determine whether or not the ingredients are Generally Recognized as Safe and Effective (GRASE).
They are meant to protect users from two types of ultraviolet (UV) radiation. Ultraviolet B (UVB) which causes primarily sunburns and ultraviolet A (UVA) which is responsible for sunburn, skin cancer, and premature skin ageing. The amount of protection against these consequences is indicated through their SPF– Sun Protection Factor- number. Which until now, the FDA had not required a consistent standard for measuring a sunscreen’s UV protection.
The Sunscreen Innovation Act (SIA)- which complements the Time and Extent Application (TEA) regulation- provides a new way to review the safety and effectiveness of nonprescription sunscreen. It requires the FDA to establish timeframes for review as well as the active ingredients within the sunscreen. The SIA has not replaced the need for the GRASE system and has also not replaced the scientific aspect needed to establish the safety of these products but has, however, added security to these products.
Sunscreen label requirements
The FDA regulations have evaluated the data to create labelling requirements so that manufacturers can continue to modernize their products without creating false images of those products to their consumers. This regulation requires products with an SPF between 2 and 14 to be labelled as “Broad Spectrum” and to have a warning stating that the product has not been shown to prevent skin cancer or early skin ageing. However, those products with an SPF of 15 or higher are allowed to state on their labels that they do reduce the risk of skin cancer and ageing as long as used as directed.
The 3 regulatory documents for labels
- Proposed Rule- This rule limits the maximum SPF value on sunscreen labels to “50+” because there isn’t enough evidence to show that values greater than 50 protect the skin more than SPF 50. This rule is to encourage data that proves that SPF values greater than 50 are in fact better.
- Advance Notice of Proposed Rulemaking (ANPR) for Dosage Forms- This will allow the public an amount of time in order to request data on the effectiveness and safety of sunscreen sprays as well as comment on what they would like in terms of dosage and effectiveness of the products.
- Draft Enforcement Guidance for Industry- This outlines information for manufacturers on how to label and test their products in line with the new rule.
In order to continue to enforce these regulations and labelling guide lines, Lascom CPG proposes a solution to help manage all the data and documentation that follows these sun protecting products as they evolve from creams to sprays to tanning or not. The solution allows manufacturers to organize and provide complete transparency of their products for better products and safer consumers.
To learn more about Lascom’s solution click here.