Drug · FAERS side-effect profile with label screen

Octocrylene and Avobenzone side effects: what 426 FDA adverse event reports show

Octocrylene, Avobenzone · 22 reaction terms · 478 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Octocrylene, Avobenzone (Cetaphil)

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

Who reports

426 reports · 31% serious · 18 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

(S ) 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 19 strongest signals

Reporting / coding artifact 1No label text to screen 18

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. 3 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
Rebound effect	14	60.8 36.3–101.9ROR 62.9 · χ² 765 / p 1e-168	56.3 EB05 35.7 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Pain of skin	25	45.6 31.2–66.7ROR 48.4 · χ² 1,047 / p 5e-230	44.1 EB05 31.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	92% consumer	no trial data cached
Rash papular	16	35.1 21.7–56.8ROR 36.4 · χ² 496 / p 3e-110	33.8 EB05 22.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.2	no trial data cached
Skin irritation	32	34.3 24.6–47.9ROR 37.1 · χ² 1,004 / p 1e-220	33.7 EB05 25.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 91% consumer	no trial data cached
Skin burning sensation	47	32.5 24.8–42.6ROR 36.5 · χ² 1,409 / p <1e-300	32.1 EB05 25.1 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.3 · 98% consumer	no trial data cached
Dermatitis contact	7	30.4 14.6–63.3ROR 30.8 · χ² 170 / p 3e-39	27.8 EB05 13.8 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dry skin	78	29.2 23.9–35.7ROR 35.5 · χ² 2,108 / p <1e-300	29.0 EB05 24.0 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.8 · 84% consumer	no trial data cached
Skin exfoliation	48	28.4 21.8–37.1ROR 31.9 · χ² 1,248 / p 1e-273	28.2 EB05 22.1 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.6 · 85% consumer	no trial data cached
Dermatitis allergic	7	27.7 13.3–57.7ROR 28.1 · χ² 154 / p 1e-35	25.3 EB05 12.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.7	no trial data cached
Dermatitis	11	26.1 14.6–46.9ROR 26.8 · χ² 242 / p 9e-55	25.0 EB05 14.7 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.8	no trial data cached
Scab	6	26.1 11.8–57.7ROR 26.4 · χ² 121 / p 2e-28	23.1 EB05 9.6 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Rash macular	18	25.5 16.2–40.0ROR 26.5 · χ² 399 / p 4e-89	24.8 EB05 16.6 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.8	no trial data cached
Eye discharge	5	24.1 10.1–57.6ROR 24.4 · χ² 89 / p 2e-21	20.0 EB05 6.5 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=5	no trial data cached
Skin fissures	9	23.5 12.3–44.8ROR 24.0 · χ² 172 / p 1e-39	22.0 EB05 11.7 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Erythema (skin redness)	84	20.1 16.6–24.4ROR 24.9 · χ² 1,524 / p <1e-300	20.1 EB05 16.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.8 · 89% consumer	no trial data cached
Acne	31	20.0 14.3–28.1ROR 21.5 · χ² 544 / p 2e-120	19.8 EB05 14.6 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Application site pain	5	11.2 4.7–26.7ROR 11.3 · χ² 37 / p 7e-10	7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Inappropriate schedule of drug administration	16	10.9 6.7–17.7ROR 11.3 · χ² 135 / p 2e-31	9.7 EB05 5.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.7	no trial data cached
Dermatitis atopic	8	7.9 4.0–15.7ROR 8.0 · χ² 42 / p 6e-11	5.8 EB05 3.1 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	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
Erythema (skin redness)	84	20.1 16.6–24.4ROR 24.9 · χ² 1,524 / p <1e-300	20.1 EB05 16.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.8 · 89% consumer	no trial data cached
Dry skin	78	29.2 23.9–35.7ROR 35.5 · χ² 2,108 / p <1e-300	29.0 EB05 24.0 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 23.8 · 84% consumer	no trial data cached
Skin exfoliation	48	28.4 21.8–37.1ROR 31.9 · χ² 1,248 / p 1e-273	28.2 EB05 22.1 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 9.6 · 85% consumer	no trial data cached
Skin burning sensation	47	32.5 24.8–42.6ROR 36.5 · χ² 1,409 / p <1e-300	32.1 EB05 25.1 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.3 · 98% consumer	no trial data cached
Skin irritation	32	34.3 24.6–47.9ROR 37.1 · χ² 1,004 / p 1e-220	33.7 EB05 25.0 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=3 · 91% consumer	no trial data cached
Acne	31	20.0 14.3–28.1ROR 21.5 · χ² 544 / p 2e-120	19.8 EB05 14.6 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial data cached
Pain of skin	25	45.6 31.2–66.7ROR 48.4 · χ² 1,047 / p 5e-230	44.1 EB05 31.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	92% consumer	no trial data cached
Rash macular	18	25.5 16.2–40.0ROR 26.5 · χ² 399 / p 4e-89	24.8 EB05 16.6 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.8	no trial data cached
Inappropriate schedule of drug administration	16	10.9 6.7–17.7ROR 11.3 · χ² 135 / p 2e-31	9.7 EB05 5.9 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 8.7	no trial data cached
Rash papular	16	35.1 21.7–56.8ROR 36.4 · χ² 496 / p 3e-110	33.8 EB05 22.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.2	no trial data cached
Rebound effect	14	60.8 36.3–101.9ROR 62.9 · χ² 765 / p 1e-168	56.3 EB05 35.7 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	–	no trial data cached
Dermatitis	11	26.1 14.6–46.9ROR 26.8 · χ² 242 / p 9e-55	25.0 EB05 14.7 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.8	no trial data cached
Skin fissures	9	23.5 12.3–44.8ROR 24.0 · χ² 172 / p 1e-39	22.0 EB05 11.7 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=1	no trial data cached
Dermatitis atopic	8	7.9 4.0–15.7ROR 8.0 · χ² 42 / p 6e-11	5.8 EB05 3.1 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=2	no trial data cached
Dermatitis allergic	7	27.7 13.3–57.7ROR 28.1 · χ² 154 / p 1e-35	25.3 EB05 12.3 · IC025 +2.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.7	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 Octocrylene and Avobenzone?

In FDA FAERS, the most frequently co-reported reaction terms for Octocrylene and Avobenzone are erythema, dry skin, skin exfoliation, skin burning sensation, skin irritation, acne. 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 Octocrylene and Avobenzone have an FDA boxed warning?

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

Do FAERS signals prove that Octocrylene and Avobenzone 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 2a6bc3f2-4e52-252b-d051-94be1ee0cc00, effective 20240416; matched on openfda.generic_name.exact:"OCTOCRYLENE, AVOBENZONE")
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, 22 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.