The FDA's public cosmetic adverse-event database contains 85,511 reports collected through the MedWatch system, spanning two decades of consumer and industry submissions. In September 2025 the agency launched a real-time public dashboard — the FAERS Public Dashboard for Cosmetic Products — making these records searchable by product name for the first time.
But raw numbers without context mislead. This article breaks down what the data actually shows, which product categories drive the most serious complaints, and what it means for aesthetic providers and patients navigating cosmetic-product safety.
What the database covers
The 85,511 reports come from the FDA's Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), now integrated into the broader FAERS dashboard. Reports are submitted through several channels:
- Voluntary reports from consumers, healthcare professionals, and salon workers (MedWatch Form 3500)
- Mandatory reports from manufacturers and distributors, required since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for serious adverse events
- Expedited 15-day reports, typically submitted when a company receives a complaint that involves death, life-threatening injury, hospitalization, or disability
Under MoCRA, signed into law on December 29, 2022, "responsible persons" (manufacturers, packers, or distributors whose name appears on the label) must report serious adverse events to the FDA within 15 business days. The law also requires them to maintain records and submit any new medical information within one year. Prior to MoCRA, cosmetic adverse-event reporting was entirely voluntary.
The report types in the database break down as follows:
| Report type | Count | Share |
|---|---|---|
| Pre-MoCRA (historical voluntary/industry) | 34,651 | 40.5% |
| Expedited (15-Day) | 33,599 | 39.3% |
| Direct (voluntary consumer/professional) | 17,255 | 20.2% |
| Periodic (non-expedited) | 6 | <0.1% |
The talc cluster: 83.7% of all reports
Before analyzing cosmetic-specific patterns, one finding dominates the dataset: 71,623 of the 85,511 reports (83.7%) are linked to talcum powder and body powder products, primarily Johnson's Baby Powder and Shower-to-Shower body powder. The vast majority of these reports list ovarian cancer, mesothelioma, or fallopian tube cancer as the adverse reaction.
This cluster is driven by the multi-year product-liability litigation against Johnson & Johnson, which produced a flood of adverse-event reports starting around 2014–2015. The spike in 2021 (13,318 total reports, of which 12,655 were talc-related) coincided with the talc subsidiary's Chapter 11 filing and associated mass-tort activity.
This article focuses on the remaining 13,888 non-talc reports, which reflect the adverse events most relevant to consumers and providers of cosmetic, personal-care, and aesthetic products.
The 10,467 pure cosmetic reports
Removing the talc cluster, concomitant supplements (2,271 reports for vitamins, fish oil, etc.) and concomitant medications (1,563 reports for prescription drugs taken alongside cosmetic products) leaves approximately 10,467 reports directly tied to cosmetic and personal-care products.
| Product category | Reports | Share of cosmetic |
|---|---|---|
| Hair Care Products | 5,163 | 49.3% |
| Skincare Products | 2,217 | 21.2% |
| Body Care / Hair Removal | 1,131 | 10.8% |
| Makeup Products | 570 | 5.4% |
| Fragrance / Deodorant | 431 | 4.1% |
| Tattoo / Permanent Makeup | 430 | 4.1% |
| Lip Products | 369 | 3.5% |
| Hair Straightening / Chemical Treatments | 254 | 2.4% |
| Nail Products | 173 | 1.7% |
| Injectable / Procedure-Related | 23 | 0.2% |
Hair care alone accounts for nearly half of all cosmetic adverse-event reports. The dominance reflects both the volume of products used and the severity of the primary reaction: hair loss.
Hair care: alopecia drives 5,163 reports
Alopecia appears in 70.9% of the 5,163 hair-care reports — making it the single most common adverse reaction across the entire cosmetic database outside the talc cluster. The top five reactions in hair-care reports:
| Reaction | Reports | % of hair-care reports |
|---|---|---|
| Alopecia | 3,663 | 70.9% |
| Pruritus (itching) | 1,174 | 22.7% |
| Trichorrhexis (hair breakage) | 766 | 14.8% |
| Hair texture abnormal | 562 | 10.9% |
| Rash | 405 | 7.8% |
Three brands dominate the complaint list:
- WEN Cleansing Conditioner (Chaz Dean): 717+ reports across product variants. The WEN hair-loss class action and FDA safety notification in 2016 generated a surge of reports. A 2017 Northwestern Medicine study published in JAMA Internal Medicine found that WEN's manufacturer had received over 21,000 consumer complaints of scalp irritation and alopecia — but only 127 had been forwarded to the FDA at the time of the agency's July 2016 safety alert.
- Monat (Monat Global Corp.): 341+ reports, with Monat Renew Shampoo (138 reports), Monat Revitalize Conditioner (51), and Monat Revive Shampoo (52) among the most-implicated products.
- DevaCurl: 344+ reports. The DevaCurl hair-loss controversy of 2020 produced a wave of MedWatch filings, with DevaCurl One Condition (66 reports), Ultra Defining Gel (58), and No-Poo (48) at the top.
The FDA contracted Columbia University's Medical Center Department of Dermatology to study the connection between these products and alopecia. The study found that mice treated with either DevaCurl Low-Poo Delight Cleanser or WEN Sweet Almond Mint Cleansing Conditioner, over a prolonged period, displayed abnormal hair growth cycles. However, the study was unable to draw a firm causal connection, and the investigation remains open.
The temporal pattern reflects these events: hair-care reports spiked from 208 in 2012 to 1,695 in 2016 (the WEN class action year), and surged again to 788 in 2024.
What this means for providers
Aesthetic providers who offer hair-restoration consultations — platelet-rich plasma (PRP), low-level laser therapy, or referral for finasteride — should ask patients about recent hair-care product changes. New-onset shedding after switching shampoo or conditioning products is a documented adverse-event pattern, and stopping the implicated product is the first intervention before proceeding with any in-clinic treatment.
Skincare: irritation, swelling, and hypersensitivity
The 2,217 skincare-product reports show a different reaction profile. The top five:
| Reaction | Reports | % of skincare reports |
|---|---|---|
| Erythema (redness) | 386 | 17.4% |
| Pruritus | 361 | 16.3% |
| Rash | 322 | 14.5% |
| Burning sensation | 315 | 14.2% |
| Hypersensitivity | 287 | 12.9% |
Skincare reports are more evenly distributed across brands and product types. Moisturizers, cleansers, serums, and acne treatments all appear. The reaction pattern — erythema, pruritus, burning, swelling — is consistent with irritant contact dermatitis and allergic contact dermatitis, the two most common adverse reactions to leave-on topical products.
For patients undergoing aesthetic procedures (chemical peels, laser resurfacing, microneedling), active contact dermatitis from a skincare product is a contraindication. The inflamed skin barrier increases the risk of complications, including prolonged erythema, post-inflammatory hyperpigmentation, and infection.
Tattoo ink and permanent makeup: an underappreciated risk category
Tattoo and permanent-makeup products account for 430+ reports — a category many patients and providers underestimate. The reaction profile is notably inflammatory:
| Reaction | Reports | % of tattoo/PMU reports |
|---|---|---|
| Swelling | 267 | 62.0% |
| Pruritus | 224 | 52.1% |
| Rash papular (raised bumps) | 159 | 37.0% |
| Hypersensitivity | 153 | 35.6% |
| Blister | 125 | 29.1% |
Tattoo ink was the single most-implicated product (64 reports), followed by generic "Tattoo" entries (29) and specific brands like A Thousand Virgins G3 Grey Wash (25) and Premier Pigments (24). Black henna tattoos — which often contain para-phenylenediamine (PPD), a potent contact allergen — appear in 43 reports.
Outcomes in this category are disproportionately serious: 54 reports (12.6%) required medical intervention, 26 (6.0%) resulted in hospitalization, 19 (4.4%) were classified as life-threatening, and 17 (4.0%) resulted in disability.
What this means for providers
Patients with permanent makeup (microbladed eyebrows, permanent eyeliner, lip blush) who present for laser or energy-based device treatments in the same area are at risk for paradoxical darkening, ink fragmentation, and inflammatory reactions. The FDA database reinforces the already-known precaution: treat over tattooed or permanently pigmented skin only with full informed consent and appropriate wavelength selection.
Lip products: the EOS pattern
EOS Lip Balm is the most-implicated product in the 369 lip-product reports, with 110 reports for EOS Lip Balm and 20 for EOS Chapstick — a total of 130 reports for a single brand. The dominant reactions:
| Reaction | Reports | % of lip reports |
|---|---|---|
| Chapped lips | 146 | 39.6% |
| Lip swelling | 95 | 25.7% |
| Lip dryness | 93 | 25.2% |
| Rash | 87 | 23.6% |
| Blister | 73 | 19.8% |
The eos lip-balm reports reflect the 2016 class-action settlement over alleged cracking, bleeding, and blistering. While individual product safety has been addressed, the pattern illustrates how even low-risk, widely used products can generate significant adverse-event volumes when a reaction pattern goes unaddressed.
Hair straightening: respiratory and hair-loss symptoms
The 254 hair-straightening reports are notable for their respiratory symptom profile — distinct from every other cosmetic category:
| Reaction | Reports | % of straightening reports |
|---|---|---|
| Eye irritation | 53 | 20.9% |
| Headache | 58 | 22.8% |
| Dyspnoea (shortness of breath) | 28 | 11.0% |
| Burning sensation | 41 | 16.1% |
| Alopecia | 57 | 22.4% |
Brazilian Blowout is the most-implicated product (56 reports). The respiratory and eye-irritation pattern is consistent with formaldehyde exposure — Brazilian Blowout and similar keratin treatments were the subject of an FDA warning letter in 2011 over methylene glycol (a formaldehyde-releasing chemical) levels.
Outcome severity across cosmetic reports
The severity distribution for cosmetic-only reports (excluding talc) shows that most are classified as serious:
| Outcome | Reports | % |
|---|---|---|
| Other Serious or Important Medical Event | 4,236 | 40.5% |
| Hospitalization | 503 | 4.8% |
| Disability | 311 | 3.0% |
| Required Intervention | 244 | 2.3% |
| Life Threatening | 207 | 2.0% |
| Death | 36 | 0.3% |
The "Other Serious or Important Medical Event" category captures cases that do not meet the threshold for hospitalization or life-threatening classification but are still classified as serious by the reporting entity. Hair loss — when severe, prolonged, or disfiguring — qualifies under this category.
Year-over-year trend
The volume of cosmetic adverse-event reports has risen significantly over the past decade:
| Year | Cosmetic reports |
|---|---|
| 2012 | 208 |
| 2014 | 283 |
| 2016 | 1,695 |
| 2018 | 918 |
| 2020 | 817 |
| 2022 | 710 |
| 2023 | 769 |
| 2024 | 1,476 |
| 2025 (partial) | 1,305 |
The 2016 spike is driven by WEN-related reports. The 2024 increase (approximately double the 2022–2023 average) coincides with the first full year of mandatory MoCRA reporting. Under MoCRA, manufacturers must now submit serious adverse events within 15 business days, meaning more events are captured than under the prior voluntary-only system.
The 2025 partial-year count (1,305 through approximately mid-year) suggests the reporting rate will continue to rise as MoCRA compliance matures and the September 2025 FAERS dashboard launch increases visibility.
Who is reporting
The gender distribution is heavily skewed:
| Gender | Reports | % |
|---|---|---|
| Female | 79,556 | 93.0% |
| Male | 3,561 | 4.2% |
| Unknown | 2,394 | 2.8% |
The female predominance reflects both the demographics of cosmetic-product use and the fact that the talc-litigation cluster disproportionately involved women.
Limitations of the data
Three caveats apply to any analysis of this database:
Report volume does not equal risk. A product with 500 reports and millions of units sold may have a lower adverse-event rate than a product with 50 reports and thousands of units sold. The database does not include sales or usage data needed to calculate incidence rates.
Causation is not established. MedWatch reports document that an event occurred after product use; they do not prove the product caused the event. A report of alopecia after using a shampoo does not mean the shampoo caused the hair loss.
Underreporting is significant. The FDA estimates that adverse events are substantially underreported for all product categories. The cosmetic adverse-event data likely captures only a fraction of actual events, particularly before MoCRA made serious-event reporting mandatory.
What patients and providers should take away
For patients choosing cosmetic products:
- Patch-test new products before full application, especially leave-on skincare, hair dyes, and products applied to the face or scalp.
- Stop using any product that causes persistent burning, itching, swelling, or hair breakage, and report the event to the FDA through the MedWatch system.
- Be cautious with black henna tattoos, which may contain PPD — a potent allergen that can cause severe contact dermatitis and sensitize you to future exposures.
For aesthetic providers:
- Screen for active product reactions before performing procedures. Irritated or inflamed skin from a cosmetic product increases complication risk from lasers, chemical peels, and microneedling.
- Ask about hair-care product changes in patients presenting with new-onset alopecia or shedding. Product discontinuation may resolve the issue without treatment.
- Document and report adverse events from cosmetic procedures through MedWatch. Under MoCRA, mandatory reporting applies to cosmetic manufacturers and distributors, but voluntary reports from providers help the FDA build a more complete safety picture.
- Check the FAERS cosmetic dashboard before recommending or using new topical products in a clinical setting. The database is searchable by product name and updated daily.
Sources
- FDA. "FDA Launches Real-Time Adverse Event Reporting Dashboard for Cosmetic Products." September 12, 2025. fda.gov/news-events/press-announcements/fda-launches-real-time-adverse-event-reporting-dashboard-cosmetic-products
- FDA. "Modernization of Cosmetics Regulation Act of 2022 (MoCRA)." fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra
- FDA. "FDA Issues Updated Instructions for Serious Adverse Event Reporting for Cosmetic Products." fda.gov/cosmetics/cosmetics-news-events/fda-issues-updated-instructions-serious-adverse-event-reporting-cosmetic-products
- Crowell & Moring LLP. "Cosmetics Under the Microscope: FDA's Expanding Regulatory Reach Under MoCRA." 2025. crowell.com/en/insights/client-alerts/cosmetics-under-the-microscope-fdas-expanding-regulatory-reach-under-mocra
- FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products. Analysis of public cosmetic adverse-event (MedWatch) reports; analysis run date 2026-06-09.
- FDA. "Hair Cleansing Products." fda.gov/cosmetics/cosmetic-products/hair-cleansing-products
- FDA. "FDA Studies Possible Connection Between Hair Loss and Certain Hair Cleansing Products." fda.gov/cosmetics/cosmetic-products/fda-studies-possible-connection-between-hair-loss-and-certain-hair-cleansing-products
- Northwestern Medicine. "Cosmetic complaints climb but products still on market." JAMA Internal Medicine, June 2017. news.northwestern.edu/stories/2017/june/cosmetic-complaints-climb
- FDA. "MedWatch: The FDA Safety Information and Adverse Event Reporting Program." fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
