FDA label 95415e5d-82cf-41f6-9a6d-6aef8f69dfe8

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 75e1d81b-4667-4520-b8a6-0354b10b85fe
SPL ID: 95415e5d-82cf-41f6-9a6d-6aef8f69dfe8
Version: 6
Effective date: 2026-01-07
Source export date: 2026-09-28
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:57:13

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		95415e5d-82cf-41f6-9a6d-6aef8f69dfe8	id
spl set id		75e1d81b-4667-4520-b8a6-0354b10b85fe	set_id

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Caution For external use only. Discontinue use if skin irratation develops or increases. If irritation persists, consult a doctor. Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Keep out of reach of children. Before use on children under 6 months, consult a doctor. Do not expose babies and young children directly to the sun. Avoid contact with textiles.

warnings and cautions

Active ingredients Octocrylene 10% Titanium Dioxide 4.15% Avobenzone 3.5% Drometrizole Trisiloxane 3% Terephthalylidene Dicamphor Sulfonic Acid 3%

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.