12 of 16ingredients FDA says need more safety data
Safety · Skin
Is sunscreen safe? What FDA and the absorption trials report
Two randomized trials found sunscreen ingredients in the blood, and FDA says 12 of 16 need more safety data. Its own page says that is not a finding that they are unsafe, and the trial authors say people should not stop using sunscreen.
On 3 November 2026, FDA's page said 12 of 16 sunscreen ingredients need more safety data, and that this is not a conclusion they are unsafe. A 2020 randomized trial found all six ingredients tested in blood above FDA's 0.5 ng/mL threshold after one application.
Source: FDA's Q&A and sunscreen pages, two JAMA trial abstracts on PubMed, the ClinicalTrials.gov record and CDC's sun safety page, read 3 November 2026.
The short version
12 of 16need more safety dataFDA: not a finding that they are unsafe
6 of 6ingredients in blood above 0.5 ng/mL2020 trial, 48 people, after one application
2removed in September 2026PABA and trolamine salicylate, risks outweigh benefits
2proposed safe and effectivezinc oxide and titanium dioxide
Sunscreen safety: claims against the recordwhat gets said, and what the record shows, read 3 November 2026
They saySunscreen chemicals soak into your blood, so skip it.
Not that simple
Two trials did find ingredients in blood above FDA's threshold, and FDA wants more data. The trial authors wrote that the results do not indicate that people should refrain from sunscreen, and FDA says the open question is not a finding of harm. See the receipt
They sayOnly mineral sunscreens are safe.
Not that simple
FDA proposed zinc oxide and titanium dioxide as safe and effective and said the other 12 lacked enough public data. It also said that is not a conclusion those 12 are unsafe, and it does not tell consumers to switch. See the receipt
They sayFDA has fully tested every sunscreen ingredient.
Not cleared
FDA's own page lists 12 ingredients for which the public record did not contain sufficient data, and says it has asked industry for more. See the receipt
What does this page read, and what does it leave out?
The main sources are two FDA pages, read in full: its question-and-answer page on regulatory actions for over-the-counter sunscreen, and its consumer page on sunscreen.[1][2] It also reads the PubMed abstracts of two randomized trials, the ClinicalTrials.gov record behind them, and the CDC's sun safety page.[3][4][5][6]
The full trial papers were not read. No product amounts or brands appear, and for trial depth, labels and reapplying see the sunscreen trial-record guide.
What does FDA say about the ingredients?
FDA's Q&A page groups the 16 ingredients in its September 2021 proposed order into three piles.[1] Its review found sufficient safety data on two, and for the other twelve the public record did not currently contain enough to make a positive determination.
Counts as the FDA Q&A page gives them for the 16 ingredients in the proposed order OTC000008. The two risks-outweigh-benefits ingredients are now a final order, and bemotrizinol was added separately in June 2026.
Proposed safe and effective: zinc oxide and titanium dioxide.
Not safe and effective because the risks outweigh the benefits: PABA and trolamine salicylate. A final order removing them was issued on 10 September 2026, and FDA says consumers do not need to take any action and that it knows of no such products sold in the US.
More data needed: cinoxate, dioxybenzone, ensulizole, homosalate, meradimate, octinoxate, octisalate, octocrylene, padimate O, sulisobenzone, oxybenzone and avobenzone.
FDA says the proposal does not represent a conclusion that the ingredients needing data are unsafe, and that it asked for more information because conditions such as how much sunscreen people use have changed.
FDA added bemotrizinol as a sunscreen active ingredient in a final order dated 10 June 2026.
Dates from the FDA Q&A page and the two PubMed records. The 12 ingredients that need more data were still open when FDA's page was current on 10 September 2026.
What did the absorption trials find?
Both trials were randomized, run at a clinical pharmacology unit, and measured sunscreen ingredients in the blood of healthy volunteers who applied sunscreen to most of the body.[3][4] FDA guidance asks that ingredients with systemic absorption above 0.5 ng/mL, or with safety concerns, get further nonclinical toxicology testing.
2019, 24 participants, four products: all four products produced blood levels above 0.5 ng/mL after four applications on the first day.
2020, 48 participants, four products and six ingredients: all six ingredients exceeded 0.5 ng/mL, and the threshold was passed on day 1 after a single application.
Both abstracts conclude the findings do not indicate that people should refrain from using sunscreen, and that the clinical significance needs further study.
ClinicalTrials.gov holds one record for the study, with 72 participants enrolled, which matches the 24 and 48 in the two papers.[5]
Highest of the product-by-product maximum plasma concentrations reported in the abstract of the 2020 JAMA trial (48 participants, four products, ng/mL). The ink bar is the 0.5 ng/mL threshold in FDA guidance. Crossing it means FDA expects more safety studies, not that harm was found.The 2019 abstract reports one participant with a rash on each of the four sunscreens, counted here as 4 of 24. The 2020 abstract reports 14. The percentages are this page's arithmetic, and no comparison group without sunscreen is described in either abstract.
The abstracts name chemical filters and ecamsule. They do not mention zinc oxide or titanium dioxide, so this page says nothing about how those are absorbed.
A level in the blood is a measurement of exposure. The abstracts do not report any harm from it.
What else does FDA's consumer page say?
FDA's sunscreen page says there is evidence that at least some sunscreen active ingredients are absorbed through the skin and enter the body, and that FDA needs to determine the safety risks of that exposure.[2] It says FDA has requested data from industry to confirm the safety of the active ingredients.
The same page says certain spray sunscreens were recalled because of benzene contamination, and advises not using recalled products. It gives no contamination levels or testing details, so neither does this page.
CDC advises using broad-spectrum sunscreen together with shade, tightly woven clothing, a full-brim hat and sunglasses that block UVA and UVB.[6]
FDA advises people concerned about sunscreen for infants, children or during pregnancy to consult a health care professional.[1]
Questions this page raises
1. Is your sunscreen one of the 12 FDA says need more safety data? Check the active ingredients on the label against the list.
2. Does it list PABA or trolamine salicylate? FDA says none is known to be sold in the US.
3. Is it a spray? FDA's page says certain spray sunscreens were recalled for benzene.
4. Is the product for a baby, or are you pregnant? FDA says ask a health professional.
5. Are you also using shade, clothes, a hat and sunglasses, as CDC advises?
PubMed papers whose title or abstract mention sunscreen and a harm or absorption word, counted 3 November 2026. A word match shows where the research is, not how often anything happens.
A word match includes papers about allergy, formulation or the environment, and it says nothing about how often anything happens in people.
It shows that the question has been studied far beyond the two trials above, and that this page has not read that research.
How should you use this page?
If you are asking whether it is safeOpen question, not a warningThe ingredients do reach the blood, FDA wants more data on 12, and no source read here reports harm from that. Ask a clinician about your own skin and situation.
If you are choosing a productRead the active ingredientsCompare the label to FDA's three lists above. FDA does not tell consumers to switch, and this page tests and rates no brand.
If you are thinking of skipping itThe trial authors advise against thatBoth abstracts say the findings do not indicate people should refrain from sunscreen, and CDC pairs it with shade, clothing and a hat.
How this page was built
Method
FDA's Q&A page, FDA's sunscreen page and CDC's sun safety page were fetched and read on 3 November 2026, and the ClinicalTrials.gov record was read through the registry's API. The two JAMA trials were read as their PubMed abstracts only. Every figure is attributed to the source that states it, the rash percentages are this page's own arithmetic, and no product amount appears.
Limits: the full trial papers were not read, no sunscreen was tested here, no brand is rated, and the 2019 and 2020 abstracts come from one registered study. The research count is a word match and measures depth of record only (our grading rules are on the methodology page, and the evidence ladder shows how other topics compare). Nothing here is medical advice.
The exact query
Sunscreen safety and absorption: (sunscreen[tiab] OR sunscreens[tiab]) AND (adverse[tiab] OR "side effect*"[tiab] OR safety[tiab] OR toxicity[tiab] OR absorption[tiab] OR "systemic exposure"[tiab])
References
abc U.S. Food and Drug Administration. Questions and Answers: FDA's regulatory actions on over-the-counter sunscreen (content current as of 10 September 2026). fda.gov, read 3 November 2026.
ab U.S. Food and Drug Administration. Sunscreen: How to Help Protect Your Skin from the Sun (content current as of 16 October 2026). fda.gov, read 3 November 2026.
ab Matta MK, et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA 2019;321(21):2082-2091. Abstract read; full paper not read. pubmed.ncbi.nlm.nih.gov, read 3 November 2026.
ab Matta MK, et al. Effect of sunscreen application on plasma concentration of sunscreen active ingredients: a randomized clinical trial. JAMA 2020;323(3):256-267. Abstract read; full paper not read. pubmed.ncbi.nlm.nih.gov, read 3 November 2026.
ab ClinicalTrials.gov record NCT03582215, Assessment of the Human Systemic Absorption of Sunscreen Ingredients (status completed; 72 participants enrolled), read through the registry API. clinicaltrials.gov, read 3 November 2026.
ab Centers for Disease Control and Prevention. Sun Safety (page dated 17 June 2026). cdc.gov, read 3 November 2026.
↑ PubMed search for sunscreen narrowed to papers that mention adverse or side effects, safety, toxicity, absorption or systemic exposure in the title or abstract; the query is printed in the method section. pubmed.ncbi.nlm.nih.gov, read 3 November 2026.
↑ National Library of Medicine. MeSH publication type: Randomized Controlled Trial. ncbi.nlm.nih.gov.
FAQ
Is sunscreen safe?
FDA says 12 of 16 ingredients in its 2021 proposed order need more safety data, and that this is not a conclusion they are unsafe. Two FDA-funded trials found ingredients in blood, and their authors wrote that the results do not indicate people should refrain from sunscreen.
Does sunscreen get into your blood?
In two randomized trials of healthy volunteers, all tested ingredients reached blood levels above 0.5 ng/mL, the level at which FDA guidance asks for further safety studies. FDA's page says at least some active ingredients are absorbed through the skin and enter the body.
Which sunscreen ingredients did FDA remove?
A final order dated 10 September 2026 removed PABA and trolamine salicylate because the risks outweigh the benefits. FDA says consumers do not need to take action and that it is not aware of such products sold in the US.
Are mineral sunscreens safer?
FDA proposed zinc oxide and titanium dioxide as generally recognized as safe and effective, and said the public record lacked enough data on 12 other ingredients. It does not say those 12 are unsafe, and it does not tell consumers to switch.
Was there a benzene recall of sunscreens?
FDA's sunscreen page says certain spray sunscreens were recalled because of benzene contamination and advises not using recalled products. It gives no contamination levels, so this page quotes none.
Bottom line
Sunscreen ingredients do get into the blood, FDA says 12 of 16 need more safety data, and FDA and the trial authors both stop short of calling them unsafe. Hold "it is poison" and "it is fully proven" up against that wording, then ask a clinician about your own skin and any pregnancy or child.
How do I cite this page?
Cite the page and the date its figures were read. Every count here is a count of records matching a published query on the day it was read, so it can move; the method box on this page prints the query so you can re-run it.
APA
Whitepill editorial desk. (2026, November 3). Is sunscreen safe? What FDA and the absorption trials report. Whitepill. https://whitepill.dev/articles/is-sunscreen-safe-what-fda-and-trials-report
BibTeX
@online{whitepill_is_sunscreen_safe_what, author = {{Whitepill editorial desk}}, title = {Is sunscreen safe? What FDA and the absorption trials report}, year = {2026}, month = nov, url = {https://whitepill.dev/articles/is-sunscreen-safe-what-fda-and-trials-report}, note = {Last modified 2026-11-03}
}
Published 3 November 2026. Last modified 3 November 2026. Where a figure rests on secondary reporting, the page says so; do not present that as a primary source.
What has changed on this page?
new Published. Figures are quoted from the two FDA pages on sunscreen regulation, the abstracts of two JAMA trials and the ClinicalTrials.gov record, read on 3 November 2026.