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◆ Free Tool · US Cosmetic Claims

Cosmetic
Claim Checker

◆ What It Does

Paste your label, product description or ad copy. The checker flags phrases that US regulators treat as drug, OTC drug, medical device or pesticide claims, explains why, and suggests cosmetic wording. It runs in your browser — nothing is uploaded.

Check Your
Product Copy

Try an example:
Drug claimOTC drug claimMedical devicePesticide (EPA)Needs evidence

A first-pass screen based on FDA, FTC and EPA guidance for the US market. Not legal advice. A clean result is not a compliance guarantee.

How It Works

Claims Decide
the Category

The FDA classifies a product by its intended use: what your label, website and ads say it does, and what customers expect. The same formula can be a cosmetic or a drug depending only on the words you put next to it.

Cosmetic

Cleanses, beautifies, changes appearance or feel: “softens”, “smooths the look of”, “cooling sensation”, “fresh scent”.

Drug or OTC drug

Treats, prevents or relieves a condition, or affects how the body works: pain relief, SPF, antibacterial, hair growth, sleep.

Medical device

Products such as vaginal moisturizers and personal lubricants, which generally need FDA 510(k) clearance.

Pesticide

Kills or repels pests or germs on surfaces and pets — regulated by the EPA and states.

Examples from the rule set

CategoryWhy it's flaggedSafer wording
OTC drug claimRelieving pain is an OTC external analgesic drug claim (FDA monograph, Drug Facts, registered drug facility).Instant cooling sensation · Warming feel on skin
OTC drug claimSunscreens and SPF claims are OTC drugs in the US.Moisturizes after sun exposure (no protection claim)
OTC drug claimGerm-killing claims on products for skin are OTC antiseptic drug claims; on surfaces or pets they are pesticide claims.Gently cleanses · Washes away dirt
OTC drug claimReducing sweat is an OTC antiperspirant drug claim. Deodorant (odor) claims are cosmetic.Controls odor · Keeps you smelling fresh
OTC drug claimControlling dandruff is an OTC drug claim.Removes visible flakes · Refreshes the scalp
OTC drug claimTreating or preventing acne is an OTC drug claim.Cleanses pores · Reduces the look of shine
OTC drug claimProtecting chafed or cracked skin and treating diaper rash are OTC skin protectant drug claims.Moisturizes and softens skin
OTC drug claimHand sanitizers are OTC drugs in the US.Hand cleanser (rinse-off, cleansing claims only)
Drug claimTreating, curing, healing or preventing a condition describes a drug, not a cosmetic.Describe appearance or feel: softens, smooths, refreshes, nourishes
Drug claimNaming a disease or medical condition implies the product treats it.Comforts dry-feeling skin · Calms the look of redness
Drug claimGrowing hair or stopping hair loss affects the body's function — a drug claim.Hair looks fuller · Reduces breakage from brushing
Drug claimThe FDA lists helping you sleep and treating anxiety or depression as drug claims, including for aromatherapy.A lavender scent for your evening routine
Drug claimRelaxing muscles or easing aches and cramps is a drug claim.Smooth massage glide · Cooling or warming feel
Drug claimRelieving menopause symptoms or affecting hormones is a drug claim.Instant cooling sensation · Softens dry-feeling skin
FAQ

Claim Checker
Questions

By its intended use. The FDA looks at the claims on the label, on your website and in advertising, and at what consumers expect the product to do. A product meant to cleanse or beautify is a cosmetic; one meant to treat or prevent disease or affect the body's structure or function is a drug — and a product can be both.
No. It is a first-pass screen that matches common phrases against rules based on FDA, FTC and EPA guidance. Context matters, and some claims depend on your exact wording, product and market. Have a regulatory professional review final labels.
No. The checker runs entirely in your browser. Nothing you paste is uploaded, saved or sent to LuxeFormula Labs.
Words like treats, heals, cures and prevents are the most common way cosmetics cross into drug territory, so the tool flags them every time. If the sentence clearly isn't about a condition — "a weekend treat for your hair" — you can ignore it.
No. A clean result means none of the tool's rules matched. Labels also need the correct identity statement, net quantity, ingredient list, business name and address, warnings where required, and under MoCRA, contact information for adverse event reports.
No. The rules are based on US law. The EU and UK use their own common criteria for cosmetic claims, and Canada has its own cosmetic-drug interface guidance.
Yes. If you are developing a product with us, we review label copy against our claims guides as part of sample approval. Send us your draft over WhatsApp or email.
Claims Guides by Category

Go Deeper
by Product

Scalp care claimsCosmetic vs drug Pet grooming claimsGrooming aid, pesticide, animal drug Spa backbar claimsMassage oil, cooling gel, magnesium Menopause body care claimsMist, oil, pillow spray PFAS state bansDeadlines 2025–2032 Free-from nail polishWhat the labels mean

Sources

  1. FDA — Is it a cosmetic, a drug, or both? (or is it soap?)
  2. FDA — Aromatherapy
  3. FTC — Health Products Compliance Guidance
  4. EPA — Pesticides and pets
  5. Perkins Coie — MoCRA requirements

Building a Product?
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Private label manufacturing from 100 units per SKU, with label copy reviewed against our claims guides during sample approval.

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