US Tattoo Ink Regulation Checker: user guide

What it is for

This tool provides client-side regulatory screening for tattoo inks and cosmetic pigments used in the United States:

• Federal MoCRA oversight (Public Law 117-328), covering postmarket adulteration, facility registration, product listing, adverse event reporting, and mandatory recall authority under the FDA.
• California Proposition 65 (California Health & Safety Code § 25249.5 et seq.), requiring warnings before exposing individuals to listed carcinogens or reproductive toxins.

Users paste ingredient statements, chemical names, Color Index (CI) numbers, or CAS numbers to screen against 15 curated high-priority substances.

Who it is for

• Tattoo artists verifying ingredient safety and potential contact allergens before tattooing.
• Studio owners maintaining audit files and handling client safety questions.
• Permanent makeup (PMU) technicians verifying pigment carriers against federal standards.
• Guest artists travelling between jurisdictions who must verify federal and California compliance.

How to use it

Switching language and visual theme

1. Click Interface Language in the header navigation.
2. Select your language from the dropdown menu.
3. Click Switch to dark theme or Switch to light theme to adjust workstation contrast.

Screening ingredient lists and Safety Data Sheets

1. Locate Paste Safety Data Sheet (SDS) Section 3, Bottle Labeling, or Ingredient Text.
2. Paste text into the box showing Paste ingredients, chemical names, or CAS numbers (e.g. CAS 1333-86-4, CI 77891, Titanium dioxide, Lead, Nickel, Toluene)....
3. Check {count} characters entered to confirm entry.
4. Click Screen Ingredient Text to parse ingredients against the database.
5. Click Clear Input at any time to reset.

Reviewing screening results and summary metrics

1. Review the Screening Results Summary card for overall totals.
2. Confirm the reference scope: Curated Reference Database: {count} substances.
3. Check total matches: Matched in Submitted Text: {count} of {total} ({percent}%).
4. Review jurisdictional figures: Subject to Federal MoCRA Framework: {count} and Listed under California Proposition 65: {count}.
5. Click View MoCRA Details → or View Prop 65 Safe Harbors → to jump to detailed findings.

Navigating federal MoCRA requirements

1. Locate Federal MoCRA Framework & FDA Non-Approval Stance citing Public Law 117-328 (Modernization of Cosmetics Regulation Act of 2022).
2. Read FDA Official Regulatory Position on Tattoo Inks on cosmetic adulteration vs premarket approval.
3. Review statutory pillars: Facility Registration (§ 607), Cosmetic Product Listing (§ 607), 15-Day Serious Adverse Event Reporting (§ 605), Mandatory Recall Authority (§ 611), and Labeling Requirements (§ 609).
4. Check Federal MoCRA Status for Matched Ingredients for matched items.

Checking California Proposition 65 Safe Harbor levels

1. Locate California Proposition 65 (Safe Drinking Water and Toxic Enforcement Act) citing California Health & Safety Code § 25249.5 et seq..
2. Read The Proposition 65 Warning Duty for businesses with 10 or more employees.
3. Review California Proposition 65 Matches in Submitted Text for endpoints and safe harbor levels.
4. Note NSRL or MADL safe harbor limits, or No Safe Harbor Level established by OEHHA.
5. Click OEHHA Primary Source → for official state records.

Browsing and filtering the curated substance database

1. Scroll to Curated Screening Database (15 Substances / Classes) subtitled Sourced directly from FDA Cosmetics (MoCRA) and OEHHA Title 27 CCR.
2. Filter entries by clicking All Jurisdictions, Federal MoCRA, or California Prop 65.
3. Type keywords into Filter curated substances by name, CAS, or CI....
4. Check matching entries via Showing {count} of {total}.

What it does not do

To clarify its operational scope, this tool does not provide the following capabilities:

• Calculate nickel release from piercing needles, body jewelry, or grips. Use the Nickel Release Calculator at https://poliinternational.com/nickel-release-calculator/
• Verify implant jewelry mill certificates or alloy standards like ASTM F136 or ISO 5832-3. Use the Material Certification Checker at https://poliinternational.com/material-certification-checker/
• Decode global cosmetic ingredients outside its curated 15-substance list. Use the Tattoo Ink Ingredient Decoder at https://poliinternational.com/ink-ingredient-decoder/
• Screen pigments against EU REACH Annex XVII Entry 75 or SVHC lists. Use the EU REACH SVHC Pigment Checker at https://poliinternational.com/reach-svhc-checker/
• Grant FDA approval, as the FDA does not approve color additives for injection into the skin.
• Submit facility registrations or product listings to FDA Cosmetics Direct.
• Perform laboratory chemical testing on physical ink bottles.
• Provide legal advice or guarantees of statutory compliance.

Where your data lives

All processing runs exclusively in your browser on your device. No data is sent to any remote server or analytics service. Pasted text resides only in volatile memory. Clicking Clear Input, refreshing the page, or closing the tab permanently deletes all entered text. Printing generates a report directly via your local operating system spooler without saving copies.

Printing and exporting

You can produce physical documentation or digital PDF reports for studio compliance files:

1. Click Print Report in the header or Print Screening Report in the navigation menu.
2. The print engine formats the dossier using a dedicated print stylesheet:

• Screen navigation, theme toggles, and buttons are omitted.
• Clean monochrome typography and borders are applied for physical printing.
• The document includes an official header, timestamp date, character count, summary metrics, matched ingredient tables, and statutory citations.

1. Select your printer or choose "Save as PDF" in your system print dialog to archive records.

Questions and answers

Has the FDA approved any tattoo ink for injection into the skin?

The FDA has not approved any color additive or finished ink for injection into the skin. Under the FD&C Act as amended by MoCRA, inks are regulated as cosmetics through postmarket safety, labeling, and adulteration rules rather than premarket approval. Inks containing harmful impurities or unapproved colorants face federal enforcement.

What is MoCRA and how does it affect tattoo studios?

MoCRA (Public Law 117-328) expanded federal FDA oversight of cosmetics, including tattoo inks. It mandates cosmetic facility registration (§ 607), product listing (§ 607), 15-day serious adverse event reporting (§ 605), and mandatory recall authority (§ 611). Studios that blend, dilute, or manufacture their own inks may need to register as cosmetic manufacturing facilities; salon-type establishments are exempt unless they manufacture or process cosmetics at that location.

When is a Proposition 65 warning required on tattoo ink in California?

Under California Health & Safety Code § 25249.5 et seq., businesses with 10 or more employees must provide warnings before exposing individuals to listed carcinogens or reproductive toxins. Warnings are mandatory unless exposure is proven below published NSRL or MADL safe harbor thresholds. Where no safe harbor level exists, a business must either give the warning or show through its own exposure assessment that no warning is required.

Why is Carbon Black listed under California Proposition 65?

Carbon Black (CAS 1333-86-4) was listed under Proposition 65 in 2003 specifically for airborne, unbound particles of respirable size. While particles in liquid ink suspensions are vehicle-bound, dry powder handling or aerosolization generates respirable particles subject to warning requirements. OEHHA has not established an NSRL safe harbor level for Carbon Black, requiring careful exposure evaluation.

Can Titanium Dioxide in tattoo ink cause problems during laser removal?

Titanium Dioxide (CI 77891, CAS 13463-67-7) is widely used in white and pastel inks and is listed under Proposition 65 for respirable particles. Laser irradiation during tattoo removal reduces titanium dioxide from white Ti(IV) to dark Ti(III), triggering immediate and often irreversible paradoxical darkening in the skin. Studios should warn clients of this reaction before treating light pigments.

Is p-Phenylenediamine (PPD) permitted in tattoo ink under federal law?

p-Phenylenediamine (PPD, CAS 106-50-3) is not an approved color additive for use on the skin. The FDA warns that "black henna" containing PPD can cause severe skin reactions, and a cosmetic containing an unapproved color additive is adulterated under FD&C Act Section 601. PPD is permitted in coal-tar hair dyes that carry the required cautionary label.

Limits

This tool operates on text pattern matching against a curated 15-substance database. It cannot verify physical bottle contents, unlisted contaminants, heavy metal traces, sterility, or manufacturer FDA registration status. Regulatory agencies (including the FDA and OEHHA), accredited analytical laboratories, and qualified legal counsel determine actual legal compliance.

Use the tool

Open the US Tattoo Ink Regulation Checker: user guide. Everything runs in your browser; nothing you enter is sent anywhere.