Sun, Sand, and Lawsuits - A Cautionary Tale

If I had a nickel for every time a global compliance launch got torpedoed by poor planning, I could finally upgrade from the free version of my own Substack. I mean, I’d be rolling in it. This week’s fortune? Brought to you by a brand that swore they weren’t launching in the EU—until, of course, they landed a massive European client and suddenly remembered the fine print in the EU’s 800-page regulatory love letter.

Shit.

Enter stage left: the baby brand, backed by a newly maternal celebrity couple with two kids, a dream, and absolutely no understanding of supply chains. Let’s call the brand InUtero—tagline: “They’re not even born, and they already have a brand they love.” Because if there’s one thing a fetus craves, it’s brand alignment.

We were moderately briefed on the brand but given no context for what was going to happen next. No invite, no prep, no product brief—just a frantic broker ringing the lab like a used car salesman trying to unload a lemon-yellow jalopy in a rainstorm: “Fantastic news—can you hop on a quick call?”

The founders? Picture sun-kissed white folk from LA in soft linen, brimmed hats, and louder entitlement. They had just discovered the term “clean ingredients” as if it were a rare gemstone. The kind of people who ask if your moisturizer has been emotionally tested. They floated into the Zoom twelve minutes late with an airy “hi hi sorry!”—the kind of apology only possible when you've never been told your break is over.

Her husband, Tim, arrived looking like Santa Monica Boulevard in July—sweaty, smug, in overpriced denim. His hair was parted down the middle like a Backstreet Boy who had just discovered breathwork. A silver rope chain, thick enough to tow a Tesla, gleamed over his retina-scorching white tee—a tee so pristine a Chinese monk must’ve steamed it.

Enter Regina. Her sunglasses arrived first—two eclipse-grade lenses that swallowed her face like a praying mantis fresh from an eye exam. A monogrammed Christian Dior tote slinked in behind her like a silent cofounder—one who had never stepped inside a factory but had opinions about “scaling clean.” She was dipped in Dior and delusion. Her hair, ironed to within an inch of its life, was tucked behind both ears in a calculated move meant to say "I'm open to feedback”—but every cell in her body was in full do-not-disturb.

Within 30 seconds, the fidgeting began. She twisted her bracelet with the anxious energy of someone about to pitch something absurd. What followed was a slow, spiraling brand “vision”—equal parts vague and aggressive—punctuated by phrases like “cruelty-free chic” and “a baby movement.”

My left eye starts to twitch and tear.

And then—she dropped the payload:
“We’re looking to launch in eight weeks.”

The silence that followed was almost reverent. Not out of respect, but in awe of the sheer audacity.

Mind you, our typical lead time is twelve weeks. To make this work, we’d have to rob Paul, blackmail Peter, and glue together scraps of raw materials like we were building a skincare line out of leftover IKEA parts.

To make matters worse: they’d already sold a massive order—100,000 vegan sunsticks to Costco—and now needed someone (anyone) to figure out how to make them.

The energy was: “We jumped out of a plane and need you to build the parachute midair, soothingly, so I can get to my pilates class by 4 pm.”

They sold 100,000 vegan sunscreen sticks without a formula, without a sample, without so much as a whiff of the nectarine-guava fragrance they’d promised. To them, this was as easy as ordering a Costco hot dog. To us? It was a category-5 formulation emergency where all hands were needed on deck.

Here’s the thing about working with celebrity skincare brands:
It’s like being asked to cater a 500-person wedding using only a microwave and emotional resilience.

The optimism is delusional.
The timelines are fictional.
And you’ll likely spend several nights typing with metaphorical (and sometimes literal) splinters in your hands while a broker breathes down your neck saying, “Can we get 5k units off the line by next week?”

Because in manufacturing land, when a celebrity says “go,” you sprint—even if the direction is unclear, the path is on fire, and the map was printed upside down.

Because—and I cannot emphasize this enough—THE FORMULA DID NOT EXIST.

There was no prototype.
No “we’ve got something in R&D.”
Nothing but vibes, ambition, and a clock that said eight weeks to launch.

Eight weeks to yank a vegan OTC sunscreen out of the void like a magician pulling a rabbit out of a flaming hat—except the rabbit needed to be SPF 30, FDA-compliant, cruelty-free, and smell like a tropical cocktail you regret ordering.

Now, if you’re still romanticizing SPF like it’s some harmless beachside fling, let me ruin that for you: sunscreen is regulated like a drug in both the U.S. and EU.

🇺🇸 In the U.S., we cling to the FDA 2011 monograph like a baby blanket.
🇪🇺 In the EU, it’s ISO 24444, ISO 24443, water resistance testing, and an entire parade of documentation.

The manufacturer I worked for had one FDA-approved sunstick: fragrance-free, non-vegan, SPF 30.
InUtero thought we could just swap the waxes for vegan ones, toss in a fruity fragrance, and call it a day. Spoiler: vegan waxes are lab-born Frankenwaxes—brittle, stubborn, and about as flexible as a frozen breadstick. Beeswax comes from bees; vegan waxes come from beakers. Aside from carnauba, which is somewhat similar to working with shale, it is rigid and, in turn, very brittle. I digress….

The broker said, “It can be bridged.” (Ahem) We were pushing 15% changes in this formula. That’s not bridging—that’s base jumping without a parachute. As the chemist on this doomed voyage, I refused to sign off. I like my license, my freedom, and my jumpsuits un-orange. The founder—whose main qualification was being the CEO’s son—signed off the formula anyway. So I rolled up my sleeves, kept my receipts, and prayed I wouldn’t end up in a class-action lawsuit with Susan from Ohio crying into her ring light.

So what does it mean to “bridge” an SPF formula?
Think of bridging like forging a fake ID and hoping the bouncer doesn’t notice. If you’ve already tested Formula A, and you want to launch a slightly tweaked Formula B without spending another $15,000 and twenty weeks, you can try to “bridge” the formulas—if:

• Active ingredients and concentrations are identical

• The base is structurally similar

• Total changes are under 5%

This isn’t swapping motor oil. It’s chemistry. Coconut oil ≠ dimethicone. And a Prius engine won’t cut it when you promised a Ferrari.

Full SPF testing? Ten humans get UV-blasted like rotisserie chickens.
Bridging? Only three to five panelists are tested, see if the numbers match the original testing parameters, and—if they do—boom: you just dodged twenty weeks and fifteen grand. If they don’t? You’re hanging your SPF claim on three people and a prayer.

Our bridging test for InUtero limped back with weak numbers. (Cue the pearl-clutching.) They insisted the test was “wrong” and continued to aim for a launch. Before launch, I requested, begged, and pleaded for a five-person panel at the very least.

“This is a liability parade,” I warned. “You’re rich. You’re famous. You are lawsuit catnip.”

Meanwhile, “stability testing” was supposedly underway while production churned full-tilt on a formula that hadn’t been validated. This wasn’t product development—it was a CSI episode co-written by the Seed of Chuckey.

They begrudgingly wrote the check. The test failed spectacularly. Did they stop? Reformulate? Own it that this wasn't an SPF 30 on the label?
Nope. They shipped it. All 100,000 SPF landmines.

Months later, they beamed:
“Great news! We sold 100K units in Europe!”
I looked up from my laptop like a pilot watching someone crack open the emergency exit mid-flight.
“Cool,” “Except that formula isn’t EU-validated and you are going to have to reformulate.”

And there it was—the slow hiss of dreams deflating. The product (thank god) is no longer on the market. I don’t know if lawsuits ever materialized, but I do know the launch process was flawed from the start.

The villain here isn’t evil people or bad science. It’s bad timelines and planning.

Rush to formulate sunscreen, and you’re not just buying complaints—you’re buying regulatory violations, refunds, and a name-drop in the New York Times that you’ll pray is about someone else.

Bonus: Compliance Cheat Sheet

Want to launch SPF? Here’s what you need.

🇺🇸 U.S. Requirements

• FDA 2011 Monograph
  

• Broad spectrum testing
  

• Water resistance (40/80 min)
  

• Final formula validation
  

🇪🇺 EU Requirements

• ISO 24444 (SPF)
  

• ISO 24443 (UVA)
  

• ISO 16217 + 18861 (Water resistance)
  

• EU Portal Notification (CPNP)
  

• Product Information File (PIF)
  

• Responsible Person in the EU