Elevated risk U.S. Food and Drug Administration

Suntegrity Sunscreen foundation recall: Higher than acceptable microbiological mold count

Recall published 2+ years ago

Higher than acceptable microbiological mold count

Suntegrity Prescription & OTC drugs — recalled prescription & otc drugs
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
June 11, 2024
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Suntegrity
Product type
Prescription & OTC drugs
Distribution
Nationwide
UPC codes
854245006187, 854245006170, 854245006224, 854245006194, 854245006217, 854245006446
Reports of harm
No adverse event reports had been received at the time of the recall.

Products covered by this recall

Sunscreen foundation

What the company announced

“The company has issued a correction to the previous announcement.”

FOR IMMEDIATE RELEASE - Jun 11, 2024 – Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 115BU that developed post-release and over time in a recent test. Out of an abundance of caution while investigating the situation, the company has decided to voluntarily recall these additional lots: 107IV, 107NU, 109NU, 117BU, 113SA, 114SA, 106BR, and 101MO even though all original and recent test results received have come back clear.

A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms. It could also cause a primary fungal skin infection if used on open wounds or sunburned skin. If it is introduced into the eye, eye infections may occur. A primary skin infection due to Aspergillus species in an immunocompromised individual should be treated medically. No adverse event reports had been received at the time of the recall.

Suntegrity Impeccable Skin Sunscreen Foundation is labelled to help prevent sunburn and is packaged in 2 oz orange tubes. The product Lot number can be found on the back side of the tube at the top where the tube is sealed. See table below for a list of all lots and expiration dates. Product was distributed online by the company and nationwide via retail stores.

  • Affected Lot: Lot# · Exp · Shade · NDC# · UPC · Mfc Fill Date
  • Affected Lot: 115BU · 06/25 · Buff · 69949-152-01 · 854245006187 · 10/26/2023
  • Affected Lot: Other Lots included out of abundance of caution
  • Affected Lot: Lot# · Exp · Shade · NDC# · UPC · Mfc Fill Date
  • Affected Lot: 107IV · 04/25 · Ivory · 69949-151-01 · 854245006170 · 9/14/2023
  • Affected Lot: 107NU · 06/25 · Nude · 69949-156-01 · 854245006224 · 11/15/2023
  • Affected Lot: 109NU · 10/25 · Nude · 69949-156-01 · 854245006224 · 3/7/2024
  • Affected Lot: 117BU · 10/25 · Buff · 69949-152-01 · 854245006187 · 3/12/2024
  • Affected Lot: 113SA · 06/25 · Sand · 69949-153-01 · 854245006194 · 10/30/2023
  • Affected Lot: 114SA · 10/25 · Sand · 69949-153-01 · 854245006194 · 3/14/2024
  • Affected Lot: 106BR · 04/25 · Bronze · 69949-155-01 · 854245006217 · 9/14/2023
  • Affected Lot: 101MO · 05/25 · Mocha · 69949-157-01 · 854245006446 · 10/9/2023

Suntegrity has notified its distributors, retailers and website customers by email and is arranging for disposal of all recalled products. All Consumers/distributors/retailers that have subject product (See Lot Numbers above) have been advised to immediately stop use and:

If you have purchased this product directly from the SuntegritySkincare.com website or via Amazon from Suntegrity: email [email protected] with your order number, product lot number, and name so your purchase can be verified. After confirmation, you will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) so that you may receive a refund, store credit or product exchange (e.g. a replacement with another Suntegrity Face SPF product).

If you purchased this product from a retailer: If you would like an exchange option (5-in-1 Tinted Sunscreen + free gift), you may contact Suntegrity directly via email at [email protected] . If you prefer a store credit, please contact the retailer from whom you originally purchased the product. In either case, you will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) to confirm receipt and processing of these recall instructions.

Consumers with questions regarding this recall can contact Suntegrity Skincare via email at [email protected] . Emails will be responded to as quickly as possible M-F between 9am and 5pm Pacific Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this over-the-counter sunscreen drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 16 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 854245006187
  • 854245006170
  • 854245006224
  • 854245006194
  • 854245006217
  • 854245006446

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 115BU
  • 107IV
  • 107NU
  • 109NU
  • 117BU
  • 113SA
  • 114SA
  • 106BR
  • 101MO

Package size

Match the net weight or the piece count on the front of the pack.

  • 2 oz

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Suntegrity — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Remedy named in the notice: After confirmation, you will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) so that you may receive a refund, store credit or product exchange (e.g. a replacement with another Suntegrity Face SPF product).

Company contact: Suntegrity Skincare — Consumers: Patricia Trimble, (657)259-0243, [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Suntegrity prescription & otc drugs recalled?

Higher than acceptable microbiological mold count A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 854245006187, 854245006170, 854245006224; lot code 115BU, 107IV, 107NU. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: After confirmation, you will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) so that you may receive a refund, store credit or product exchange (e.g. a replacement with another Suntegrity Face SPF product).

Where was the recalled product sold?

It was distributed nationwide.

Related recalls