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…`

Reported adverse events (FAERS/openFDA)#

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

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 94 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eucerin Advanced Hydration Sunscreen SPF 30	(TO DELIVER) AVOBENZONE 3%, HOMOSALATE 7%, OCTISALATE 4.5%, OCTOCRYLENE 8%	Beiersdorf Inc	1273012a-107c-1b19-e063-6394a90a53e4	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Face Hydrating Clear Sunscreen SPF 60	AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23e5bf2c-88c2-d346-e063-6394a90abc78	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Every Tone Invisible Clear Sunscreen Stick SPF 55	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	23fb728a-8c11-d041-e063-6294a90abb55	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sport Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	c0421c97-72bd-fcac-e053-2995a90aac28	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Defend and Clear	OCTINOXATE, OCTISALATE, ZINC OXIDE	Beiersdorf Inc	baaec6a9-2c60-2d11-e053-2a95a90abca7	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Pure and Simple Sunscreen SPF 50	ZINC OXIDE 24.08%	Beiersdorf Inc	b6492438-5dd2-030e-e053-2a95a90a2f9f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 30	AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdort Inc	ca8d2e20-c1f1-ecf2-e053-2a95a90a790f	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Tinted Age Defense Suncreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10%	Beiersdorf Inc	125d053c-9418-5772-e063-6294a90a6d6d	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport SPF 15 Sunscreen	AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7%	Beiersdorf Inc	cc4812da-0686-7789-e053-2995a90a561f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Mineral Sunscreen SPF 50	ZINC OXIDE	Beiersdorf Inc	b6861830-fdad-3829-e053-2a95a90a0971	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Tear Free Mineral Sunscreen SPF 50	OCTINOXATE 7.5%, OCTISALATE 5%, ZINC OXIDE 14.5%	Beiersdorf Inc	c054fd86-b0d9-24fc-e053-2a95a90aea2c	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sunscreen SPF 70	AVOBENZONE 3%, HOMOSALATE 13%, OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	c0552256-d8cb-5473-e053-2995a90ad0d5	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Kids Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	c068a6e7-260f-0766-e053-2995a90a422f	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Suncreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	cc43f433-51ff-ed6a-e053-2a95a90ad3c5	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Mineral Sunscreen SPF 50	ZINC OXIDE	Beiersdorf Inc	b5bb6eb6-3356-e2a5-e053-2995a90aa684	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Limited Edition Sunscreen SPF 50	AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5%	Beiersdorf Inc	ccbf7795-e153-1a43-e053-2a95a90ad4b6	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advanced Hydration SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd9cbdb4-42f1-3063-e053-2a95a90a08aa	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Baby Sensitive Mineral SPF 50 Sunscreen	ZINC OXIDE	Beiersdorf Inc	cdb19c82-9845-eabc-e053-2a95a90a31f7	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Advance Hydration Sunscreen SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cd61e4d7-776d-8d84-e053-2995a90a4819	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Oil-Control SPF 50 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	cda04484-ba84-2276-e053-2a95a90a41c8	2025-12-31	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