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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11045-0303-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11045-0303-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11045-0303-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11045-0303-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11045-0303-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11045-0303-30efc9e666f02…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
IngredientStrength
ZINC OXIDE223 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11045-0303-1Soleo Organics Sunscreen40 g in 1 TUBECREAM406
11045-0303-2Soleo Organics Sunscreen80 g in 1 TUBECREAM806
11045-0303-2Soleo Organics Sunscreen1 in 1 CARTONCREAM16
11045-0303-3Soleo Organics Sunscreen150 g in 1 TUBECREAM1506
11045-0303-3Soleo Organics Sunscreen1 in 1 CARTONCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Zinc OxideACTIVE INGREDIENTSOI2LOH54ZSOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SKIN ELEMENTS USA, LLC]1
Zinc CationACTIVE MOIETY13S1S8SF37SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SKIN ELEMENTS USA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11045-0303SOLEO ORGANICS SUNSCREEN (ZINC OXIDE) CREAM [SE OPERATIONS PTY LTD]6Current NDC, Legacy NDC, 5 package rows20250126_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 31 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunPlus Healthy Skin Sunny Living SPF 30 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC9b168046-3536-4ba9-9b5f-4f8c50b8b3542026-05-14WarningsExact identifier
application number: M020
SunPlus Healthy Skin Sunny Living SPF 50 Mist SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC0e60ecee-d9f4-47e0-92f7-ff319e4422dd2026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 15 SunscreenOCTOCRYLENE 7.50% AVOBENZONE 2.50% OCTISALATE 5.00%S&C Hampton Sun LLC3ce75e74-b5d3-4fbe-8d44-9b6f14f354df2026-05-14WarningsExact identifier
application number: M020
Target Up and Up SPF 30 Deep Repair Facial Moisturizer SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION51c9bdee-dcff-2818-e063-6294a90abb472026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 50 Baby MineralZINC OXIDE 20%S&C Hampton Sun LLC42037d8c-4787-4e16-93fe-0d19b6b888fd2026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIE29c9d1cb-e249-47fa-a46d-42190e59d3522026-05-14WarningsExact identifier
application number: M020
Hampton SPF 15 UV-Advanced SunscreenHOMOSALATE 7.50% OCTISALATE 5.00% AVOBENZONE 3.00%S&C Hampton Sun LLC1659a681-6cf8-45ba-b1f8-e330eee3b9d42026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cd48cf-38ae-f347-e063-6294a90a8a902026-05-14WarningsExact identifier
application number: M020
Hampton Sun SPF 4OCTOCRYLENE 4.00% AVOBENZONE 2.00%S&C Hampton Sun LLC68763abc-0d6b-441c-9a99-cf3dc86e6deb2026-05-14WarningsExact identifier
application number: M020
Easy Everything SunscreenZINC OXIDEVLT Ventures LLC51cdbac3-7f44-d72d-e063-6294a90a2f992026-05-14WarningsExact identifier
application number: M020
Round Lab x OUWR Birch Juice Moisturizing UVLOCK Gift SetAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4feb1010-469f-7e6e-e063-6394a90a9a9e2026-05-14WarningsExact identifier
application number: M020
Round Lab Summer Travel KitAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.4f8722e2-4636-e8ba-e063-6294a90a91e42026-05-14WarningsExact identifier
application number: M020
La Roche Posay Anthelios UV Air Serum Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incf3d841aa-b4fe-4a9d-8ad2-edd4445852d22026-05-14WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Sunscreen Broad Spectrum SPF 15 Firming AntiWrinkleAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incb746c24d-f775-4433-8519-49c3ec48ea0c2026-05-14WarningsExact identifier
application number: M020
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc92a1d6ce-aff3-45fc-8d98-20c4375aded82026-05-14WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATA,ETHYLHEXYL SALICYATEGuangzhou Haishi Biological Technology Co., Ltd.519d9f52-b704-d6cd-e063-6294a90a6e422026-05-13WarningsExact identifier
application number: M020
Hampton Sun SPF30 MineralZINX OXIDES&C Hampton Sun LLC019b0c1a-f9f3-4756-8b24-35bf4dc4aa222026-05-13WarningsExact identifier
application number: M020
Standard Procedure SPF 50 Sunscreen Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories34f6150d-9627-94a5-e063-6394a90ad4482026-05-13WarningsExact identifier
application number: M020
CeraVe Developed with Dermotologists Ultra Light Moisturizing Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdefa9588-95be-4f5c-86bb-53d6a1df7f5f2026-05-13WarningsExact identifier
application number: M020
MELAO TALLOW SUNSCREENETHYLHEXYL METHOXYCINNAMATEGuangzhou Haishi Biological Technology Co., Ltd.22982b28-37df-ed81-e063-6394a90a77db2026-05-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11045-0303-11104503030140 g in 1 TUBE (11045-0303-1) 40 g2007-01-200000-00-00NoNoCurrent
11045-0303-2110450303021 TUBE in 1 CARTON (11045-0303-2) / 80 g in 1 TUBE1 tube2007-01-200000-00-00NoNoCurrent
11045-0303-3110450303031 TUBE in 1 CARTON (11045-0303-3) / 150 g in 1 TUBE1 tube2007-01-200000-00-00NoNoCurrent