Soleo Organics Sunscreen

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)

Brand name: Soleo Organics Sunscreen
Generic name: ZINC OXIDE
Manufacturer: SE Operations Pty Ltd
Product type: HUMAN OTC DRUG
SPL set ID: 59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b
SPL ID: 0dbd6b43-a7ad-46ad-8d5e-44aa8459be89
Version: 6
Effective date: 2025-01-22
Source export date: 2026-11-06
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-11-06/7dfa569f2d8f065241260fd9a4886d0ef0a3120fd6ee31d6d07c234e689e8c91/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run: 20261106T075659Z
Imported at: 2026-11-06 08:21:07

Harmonized routes table
Harmonized routes
TOPICAL

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M020	openfda.application_number
brand name		Soleo Organics Sunscreen	openfda.brand_name
generic name		ZINC OXIDE	openfda.generic_name
manufacturer name		SE Operations Pty Ltd	openfda.manufacturer_name
ndc	package	11045-0303-2	openfda.package_ndc
ndc	package	11045-0303-3	openfda.package_ndc
ndc	package	11045-0303-1	openfda.package_ndc
ndc	product	11045-0303	openfda.product_ndc
ndc11	package	11045030303	derived:openfda.package_ndc
ndc11	package	11045030302	derived:openfda.package_ndc
ndc11	package	11045030301	derived:openfda.package_ndc
spl id		0dbd6b43-a7ad-46ad-8d5e-44aa8459be89	id
spl set id		59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b	set_id
unii		SOI2LOH54Z	openfda.unii

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only When using this product keep out of eyes, rinse with water to remove Keep out of reach of children Avoid prolonged exposure to the sun Wear protective clothing, hats and eye wear when in the sun Stop use and ask a doctor if rash or irritation develops and lasts

Reported adverse events (FAERS/openFDA)#

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