Drug · FAERS side-effect profile with label screen

Avobenzone and Octisalate and Octocrylene side effects: what 999 FDA adverse event reports show

Avobenzone, Octisalate, And Octocrylene · 14 reaction terms · 1,414 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Avobenzone, Octisalate, And Octocrylene (Vitazing Spf 15 Energy Boosting Moisturizer With Mangosteen Broad Spectrum Spf 15)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

999 reports · 0% serious · 0 with death outcome · 100% female

openFDA FAERS counts, all years, deduplication not applied

Used for

helps prevent sunburn if used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun

FDA label, Indications and Usage

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 14 strongest signals

Reporting / coding artifact 3No label text to screen 11

What the badges mean

Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 0 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Acne	258	71.3 64.2–79.2ROR 95.8 · χ² 17,823 / p <1e-300	70.7 EB05 63.8 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Skin burning sensation	236	69.9 62.5–78.1ROR 91.2 · χ² 15,951 / p <1e-300	69.3 EB05 62.2 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 327.7 · 100% consumer	no trial data cached
Skin irritation	148	67.9 58.5–78.8ROR 79.5 · χ² 9,679 / p <1e-300	67.1 EB05 58.5 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · 100% consumer	no trial data cached
Pain of skin	52	40.5 31.1–52.8ROR 42.7 · χ² 1,962 / p <1e-300	39.9 EB05 31.6 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	98% consumer	no trial data cached
Dry skin	217	34.7 30.8–39.0ROR 44.0 · χ² 7,097 / p <1e-300	34.5 EB05 30.8 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 99.5 · 100% consumer	no trial data cached
Skin exfoliation	90	22.8 18.7–27.7ROR 24.9 · χ² 1,856 / p <1e-300	22.6 EB05 19.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial data cached
Erythema (skin redness)	178	18.2 15.9–20.8ROR 21.9 · χ² 2,905 / p <1e-300	18.2 EB05 16.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.0 · 99% consumer	no trial data cached
Scar	10	12.2 6.6–22.7ROR 12.4 · χ² 92 / p 4e-22	10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Rash macular	20	12.1 7.8–18.6ROR 12.3 · χ² 192 / p 5e-44	11.2 EB05 7.2 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Inappropriate schedule of product administration	95	11.3 9.3–13.7ROR 12.4 · χ² 887 / p 3e-195	11.1 EB05 9.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	98% consumer	no trial data cached
Underdose	33	9.5 6.8–13.3ROR 9.8 · χ² 243 / p 5e-55	8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
Skin fissures	8	8.9 4.5–17.7ROR 9.0 · χ² 48 / p 2e-12	6.6 EB05 3.4 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dermatitis	8	8.1 4.1–16.2ROR 8.2 · χ² 43 / p 3e-11	6.0 EB05 3.1 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Overdose	61	5.9 4.6–7.5ROR 6.2 · χ² 247 / p 7e-56	5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	98% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Acne	258	71.3 64.2–79.2ROR 95.8 · χ² 17,823 / p <1e-300	70.7 EB05 63.8 · IC025 +5.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Skin burning sensation	236	69.9 62.5–78.1ROR 91.2 · χ² 15,951 / p <1e-300	69.3 EB05 62.2 · IC025 +5.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 327.7 · 100% consumer	no trial data cached
Dry skin	217	34.7 30.8–39.0ROR 44.0 · χ² 7,097 / p <1e-300	34.5 EB05 30.8 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 99.5 · 100% consumer	no trial data cached
Erythema (skin redness)	178	18.2 15.9–20.8ROR 21.9 · χ² 2,905 / p <1e-300	18.2 EB05 16.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.0 · 99% consumer	no trial data cached
Skin irritation	148	67.9 58.5–78.8ROR 79.5 · χ² 9,679 / p <1e-300	67.1 EB05 58.5 · IC025 +5.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1 · 100% consumer	no trial data cached
Inappropriate schedule of product administration	95	11.3 9.3–13.7ROR 12.4 · χ² 887 / p 3e-195	11.1 EB05 9.3 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	98% consumer	no trial data cached
Skin exfoliation	90	22.8 18.7–27.7ROR 24.9 · χ² 1,856 / p <1e-300	22.6 EB05 19.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	99% consumer	no trial data cached
Overdose	61	5.9 4.6–7.5ROR 6.2 · χ² 247 / p 7e-56	5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	98% consumer	no trial data cached
Pain of skin	52	40.5 31.1–52.8ROR 42.7 · χ² 1,962 / p <1e-300	39.9 EB05 31.6 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	98% consumer	no trial data cached
Underdose	33	9.5 6.8–13.3ROR 9.8 · χ² 243 / p 5e-55	8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	97% consumer	no trial data cached
Rash macular	20	12.1 7.8–18.6ROR 12.3 · χ² 192 / p 5e-44	11.2 EB05 7.2 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Scar	10	12.2 6.6–22.7ROR 12.4 · χ² 92 / p 4e-22	10.2 EB05 5.2 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dermatitis	8	8.1 4.1–16.2ROR 8.2 · χ² 43 / p 3e-11	6.0 EB05 3.1 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Skin fissures	8	8.9 4.5–17.7ROR 9.0 · χ² 48 / p 2e-12	6.6 EB05 3.4 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Avobenzone and Octisalate and Octocrylene?

In FDA FAERS, the most frequently co-reported reaction terms for Avobenzone and Octisalate and Octocrylene are acne, skin burning sensation, dry skin, erythema, skin irritation, skin exfoliation. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Avobenzone and Octisalate and Octocrylene have an FDA boxed warning?

No. The FDA label retrieved for Avobenzone and Octisalate and Octocrylene has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Avobenzone and Octisalate and Octocrylene causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 0fac5204-df18-4774-bb53-115513cb7ff0, effective 20241225; matched on openfda.generic_name.exact:"AVOBENZONE, OCTISALATE, AND OCTOCRYLENE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 14 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.