OTC & sunscreen
SPF is a drug. We manufacture it like one.
Formology Lab is an FDA-registered drug establishment in Chatsworth, California, making OTC monograph sunscreen under cGMP: validated process, tested water system, and a batch record that follows every unit off the line.
Mineral
Zinc oxide and titanium dioxide, dispersed to avoid the grey cast that kills a repeat purchase.
Hybrid
Zinc oxide paired with bemotrizinol (BEMT) to reach SPF 50 at a wearable, non-whitening texture. No purely chemical systems.
Formats
Lotion, fluid, stick, tinted base, and SPF layered into a daily moisturizer.
Beyond SPF
Anti-dandruff, acne and anti-perspirant under their own monographs, on the same registration and the same testing discipline.
The testing schedule
What an OTC program has to pass.
| Test | What it is | Elapsed |
|---|---|---|
| SPF / broad spectrum | In-vivo at an accredited outside lab | 5–7 weeks |
| Water resistance | 40 or 80 minutes, in-vivo | with SPF |
| Stability | 4/8/12 weeks at 40°C, freeze-thaw, light | 12 weeks |
| Preservative efficacy | USP 51 challenge | 4 weeks |
| Micro & viscosity | Every batch, before release | per batch |
Total OTC program: 12–17 weeks from approved brief. Cosmetic SKUs run 8–12.
Straight answers
Is Formology Lab an FDA-registered OTC drug manufacturer?
Yes. Formology Lab operates a registered drug establishment in Chatsworth, California, and manufactures OTC monograph sunscreen under cGMP.
Which sunscreen filters can you formulate with?
Mineral systems built on zinc oxide and titanium dioxide, and hybrid systems that pair zinc oxide with bemotrizinol (BEMT). We do not formulate purely chemical sunscreens.
How long does an OTC sunscreen program take?
Twelve to seventeen weeks from approved brief. SPF and broad-spectrum testing at an outside lab is the long pole, typically five to seven weeks.
What is the minimum order for OTC sunscreen?
Ten thousand units per SKU, the same as a cosmetic run, with the additional testing an OTC drug product requires.