Soleo Organics Sunscreen

Product NDC: 11045-0303
11-digit product format: 110450303
Labeler code: 11045
Product ID: 11045-0303_0dbd6b43-a7ad-46ad-8d5e-44aa8459be89
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: SE Operations Pty Ltd
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-01-20
Substance: ZINC OXIDE
Active strength: 223 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11045-0303-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11045-0303-2	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11045-0303-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11045-0303-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11045-0303-2	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11045-0303-3	`0efc9e666f02…`	`f202fb6c5f17…`

Additional Listing Data#

Finished product: Yes
Brand name base: Soleo Organics Sunscreen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	223 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
11045-0303-1	Soleo Organics Sunscreen	40 g in 1 TUBE	CREAM	40	6
11045-0303-2	Soleo Organics Sunscreen	80 g in 1 TUBE	CREAM	80	6
11045-0303-2	Soleo Organics Sunscreen	1 in 1 CARTON	CREAM	1	6
11045-0303-3	Soleo Organics Sunscreen	150 g in 1 TUBE	CREAM	150	6
11045-0303-3	Soleo Organics Sunscreen	1 in 1 CARTON	CREAM	1	6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SKIN ELEMENTS USA, LLC]	1
Zinc Cation	ACTIVE MOIETY	13S1S8SF37	SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SKIN ELEMENTS USA, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11045-0303	SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SE OPERATIONS PTY LTD]	6	Current NDC, Legacy NDC, 5 package rows	20250126_59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 361 · 7,202 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISNTREE HYALURONIC ACID SENSITIVE SUNSCREEN	ZINC OXIDE	ISNTREE Inc.	58e38665-0bca-fb02-e063-6394a90ad62a	2026-08-13	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Daily Face Sunscreen Broad Spectrum SPF 70	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d3d390-8b88-a6fe-e063-6394a90a9bf8	2026-08-12	Warnings	Exact identifier application number: M020
Neutrogena Clear Face Sunscreen Acne Prone Skin Broad Spectrum SPF 60	AVOBENZONE, BEMOTRIZINOL, HOMOSALATE, OCTISALATE	Kenvue Brands LLC	58d7a3e3-b7df-43ce-e063-6294a90a729c	2026-08-12	Warnings	Exact identifier application number: M020
Elta MD Skincare UV Stick Broad Spectrum SPF50	ZINC OXIDE	CP Skin Health Group, Inc	58dd81db-46d4-d763-e063-6394a90abb0b	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50 Red Correcting	ZINC OXIDE	CP Skin Health Group, Inc.	26e63890-d1af-d171-e063-6394a90af828	2026-08-12	Warnings	Exact identifier application number: M020
UV Skin Recovery SPF 50	ZINC OXIDE	CP Skin Health Group, Inc.	26d2683f-cfd5-50fd-e063-6394a90a7576	2026-08-12	Warnings	Exact identifier application number: M020
doTERRA Sun Body	MINERAL SUNSCREEN	doTERRA International, LLC	58dcc56f-f093-469c-e063-6394a90a6088	2026-08-12	Warnings	Exact identifier application number: M020
Colorescience Total Protection Body Shield Glow	ZINC OXIDE	Colorescience	52e1d987-a4f8-195e-e063-6294a90a5629	2026-08-11	Warnings	Exact identifier application number: M020
Stay Ageless Tinted Mineral Sunscreen	BROAD SPECTRUM SPF30	DR. SAMRAO'S OFFICE	58b2ca35-11ed-d848-e063-6294a90a5b37	2026-08-11	Warnings	Exact identifier application number: M020
Ciele Tint and Protect	ZINC OXIDE	Ciele	0162d9c9-07fa-9210-e063-6294a90aa687	2026-08-11	Warnings	Exact identifier application number: M020
NeoStrata Skin Active Matrix Support SPF 30	AVOBENZONE, OCTINOXATE, AND OCTISALATE	NeoStrata Company Inc.	8e4b9c08-b906-4c5f-a243-55838ae28b90	2026-08-10	Warnings	Exact identifier application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREEN	ZINC OXIDE,TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	4339df13-77d3-31a1-e063-6394a90a5208	2026-08-10	Warnings	Exact identifier application number: M020
Sunscreen for Kids SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	1c7cd904-ffff-48aa-91bd-cc978946b36a	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M020
Sport Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE	The Kroger Co.	22aa46af-5d0f-4256-8f45-be06f6627561	2026-08-10	Warnings	Exact identifier application number: M020
Colorescience Total Protection No Show Mineral Body Shield	ZINC OXIDE	Colorescience	52e1f59e-63cb-7480-e063-6394a90ad7c5	2026-08-10	Warnings	Exact identifier application number: M020
Journee Firm Riche Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Merz North America, Inc.	d4d4bfcf-3674-4847-8ad8-1716a8e821ae	2026-08-10	Warnings	Exact identifier application number: M020
ULTRA VIOLETTE Unblock Screen SPF 50 Sunscreen	BEMOTRIZINOL, OCTOCRYLENE, ZINC OXIDE	Grace and Fire USA Inc.	56ad0dce-410e-9d78-e063-6294a90a1c3e	2026-08-09	Warnings	Exact identifier application number: M020
ORLASKIN SPF50 Antioxidant SoothingComplex Sunscreen	ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE BUTYL METHOXYDIBENZOYLMETHANE ZINC OXIDE BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE	Guangzhou Yapheon Health Industry Co., Ltd.	552a36ed-7a66-4048-e063-6394a90a09bc	2026-08-08	Warnings	Exact identifier application number: M020
lip balm SPF15( 2533) 01	AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5870aa44-1375-cdc5-e063-6394a90af4a5	2026-08-07	Warnings	Exact identifier application number: M020
lip balm SPF15( Zinc oxide) 01	ZINC OXIDE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	5871ab1d-cf07-d737-e063-6394a90a58fe	2026-08-07	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11045-0303-1	11045030301	40 g in 1 TUBE (11045-0303-1)	40 g	2007-01-20	0000-00-00	No	No	Current
11045-0303-2	11045030302	1 TUBE in 1 CARTON (11045-0303-2) / 80 g in 1 TUBE	1 tube	2007-01-20	0000-00-00	No	No	Current
11045-0303-3	11045030303	1 TUBE in 1 CARTON (11045-0303-3) / 150 g in 1 TUBE	1 tube	2007-01-20	0000-00-00	No	No	Current