Sunscreen status & SPF compliance

Our mineral zinc sunscreen is not ready to sell. In the United States a product that carries an SPF number is regulated as a non-prescription drug, not as a cosmetic, and every claim on the pack has to be backed by laboratory testing we do not yet hold.

This page is published deliberately: we would rather show the open list than print an SPF we cannot evidence. 11 of the 12 items below are still outstanding.

• Sunscreen is a drug, not a cosmetic

  In the United States, any product that claims an SPF is regulated by the FDA as an over-the-counter drug under the sunscreen monograph (21 CFR 352 as amended by the CARES Act). Everything below follows from that.

  Outstanding

• Monograph-eligible active ingredients only

  Zinc oxide (up to 25%) and titanium dioxide (up to 25%) are the two filters currently accepted as generally recognised as safe and effective. The exact active and its percentage must be fixed and documented by the manufacturer.

  Outstanding

• SPF testing on human subjects

  An in-vivo SPF determination by an accredited laboratory (FDA method, ISO 24444 equivalent) is required before any SPF number can appear on the label or the website. We do not have a test report.

  Outstanding

• Broad spectrum test

  The in-vitro critical wavelength test (FDA broad spectrum method) must pass at 370 nm or above before the words 'broad spectrum' may be used.

  Outstanding

• Water resistance test

  The label may only say '40 minutes' or '80 minutes' water resistant if that specific immersion test has been run. With no test, the label must carry the standard warning that the product is not water resistant.

  Outstanding

• Drug Facts label

  The pack needs a compliant Drug Facts panel: active ingredients with percentages, uses, warnings, directions, other information, inactive ingredients, and the name and address of the manufacturer, packer or distributor.

  Outstanding

• Manufacturer registration and product listing

  The facility that makes the sunscreen must be registered with the FDA and the finished drug product listed, with a National Drug Code. This sits with the manufacturer, not with us, but we must hold evidence of it.

  Outstanding

• Drug GMP manufacturing

  Sunscreen must be produced under pharmaceutical good manufacturing practice (21 CFR 210/211), which is stricter than cosmetic GMP. A supplier's cosmetic certificate is not enough.

  Outstanding

• Batch records and stability

  Each batch needs a certificate of analysis and supporting stability data covering the shelf life printed on the pack. These go in our private product test register before any batch ships.

  Outstanding

• Claims we may make

  Only claims the testing supports. No 'all-day protection', no 'sunblock', no 'waterproof', no 'prevents skin cancer' beyond the exact wording the monograph permits for a broad spectrum SPF 15 or higher product.

  Outstanding

• Product liability insurance

  A drug product carries higher liability than a cosmetic. Cover should be in place before the first unit ships.

  Outstanding

• No SPF claims on this site until the above is complete

  Until the testing and labelling exist, the mineral sunscreen is not offered for sale and no SPF number is presented as verified anywhere on the storefront.

  In place

Other markets treat sunscreen differently: in the EU and UK it is a cosmetic with its own testing rules (ISO 24444 for SPF, ISO 24443 for UVA, and the UVA-in-circle mark), and in Australia it is a therapeutic good regulated by the TGA. We will not ship a sunscreen into a market whose rules we have not met.

If you want to see a test report or certificate before buying anything from us, ask — and if we cannot show you one, we will say so plainly.