Getting a sunscreen to market and keeping it on shelf is a laborious project. Luckily, the Society of Cosmetic Chemists has a cadre of experts to help indie brands and established players succeed. Prior to last month’s Sunscreen Symposium, the SCC held a one-day Continuing Education Program (CEP). The course was designed to help attendees understand the scope and significance of launching a compliant sunscreen product.

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Marisa Furlonge, director of R&D, Cosmetic Solutions, identified essential testing requirements for SPF, broad spectrum and water resistance claims. She evaluated formulation strategies tailored to diverse skin types and market regions. After reviewing sunscreen basics, Furlonge detailed a sunscreen development framework. Each region has its own list of approved/banned UV filters, concentration limits and test method requirements. Formulators must choose appropriate UV filters for efficacy, safety and regulatory compliance. They must establish formula restrictions, that align formulation with legal and brand-specific constraints. Along the way, chemists must align the formulation with consumer expectations and usability. Select oil-in-water or water-in-oil types; and choose the appropriate emulsion system based on product goals.

“Formulators must ask themselves, ‘Who is it for?,’ ‘Where is it being sold?,’ ‘How does it work?,’” said Furlonge.

All three are important questions as, unlike the rest of the world, the US FDA regulates sunscreens as drugs. As a result, formulators have a limited palette of ingredients to work with when formulating sunscreens.

UV Filter Choice in the US

Active  UV Protection Max %

Avobenzone    UVA     3

Homosalate    UVB     15

Octinoxate      UVB     7.5

Octisalate        UVB     5

Octocrylene    UVB+some UVA II   10

Oxybenzone    UVA + UVB      6

TiO2          UVB + some UVA        25

Zinc Oxide       UVA + UVB      25

Elsewhere, in Canada, sunscreens are regulated by Health Canada and classified as a natural health product or nonprescription drug. In Europe, sunscreens are regulated under the EU Cosmetics Regulation and classified as cosmetic products. In Australia, they are regulated by the Therapeutic Goods Administration. In South America, regulations vary by country, but are generally classified as cosmetics or drugs governed by its national health agency. Of course, labeling and claims must comply with each region’s rules; e.g., SPF claims, water resistance and broad spectrum.

NPD Flow Chart

Furlonge introduced a sunscreen development flow chart to help formulators understand the process is measured in years—as many as three years—not weeks. It involves 13 steps:

            • Formula development—Market region/claim review, filter selection;

            • Formula/Regulatory screening—SPF screening (in-vitro or 3-5 subjects in vivo), stability screening;

            • Perform Manufacturer Audit—FDA registered, cGMP compliant;

            • Analytical Testing—Method verification, preservative efficacy testing, heavy metal/1,4 dioxane, HRIPT testing;

            • Pilot Batches—Analytical assay verification, analytical preservative verification, pre-market stability and compatibility;

            • SPF Testing—10 panel SPF testing, broad-spectrum testing, water-resistance testing;

            • Generate Artwork—Drug facts labeling (compliance with 21 CFR 352), confirm SPF label claims (water resistance and broad spectrum);

            • FDA Registration—Drug product listing in FDA database, NDC (National Drug Code) assignment for the sunscreen product);

            • Validation Batches—Perform 3 validation batches, perform filling validation, complete validation report;

            • Product Launch;

            • Continuous Production—Utilize validated processes revalidation required for process changes, new filling validation required for component changes;

            • Ongoing Stability—Annual stability required, confirmation of expiration;

            • Ongoing Registrations—Manufacturing facility must register with FDA annually.

Post launch, responsibilities continue for formulators. They include annual product review, evaluate ongoing product performance, quality, safety and regulatory compliance. Implementing an adverse event reporting system to track and report consumer complaints. Monitor FDA updates and other regulatory bodies to maintain OTC Drug listing status and product registrations, as well as monitor regulatory changes. To ensure product integrity, continue real-time and accelerated stability testing throughout shelf life. Finally, market surveillance involves monitoring consumer feedback, evolving claims and continued alignment with clean standards.