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 16 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Daily Wear Face Protection Mineral Based Sunscreen SPF 16 - Fair LightZINC OXIDEREJUVA MINERALS INC2abccc86-01d4-e45c-e063-6294a90a7f8b2026-07-02WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
application number: M020
Sunscreen SPF 50AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf5e2a412-e891-411d-85da-89f38cd61a9b2026-07-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Bronze KissAVOBENZONE,HOMOSALATE,OCTISALATEBath & Body Works, Inc.5606c57b-7fdb-4317-e063-6294a90a996c2026-07-02WarningsExact identifier
application number: M020
Evereden Kids Mineral Sunscreen SPF 30ZINC OXIDEEden Brands Incbba219a4-de83-76fd-e053-2995a90a2d692026-07-01WarningsExact identifier
application number: M020
Kids Mineral Face Cream SPF20ZINC OXIDEEden Brands Incfbfccb0c-e459-3282-e053-6394a90ad95d2026-07-01WarningsExact identifier
application number: M020
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
application number: M020
Zinc Oxide 20%SUNSCREEN SPF 50The Beach Roosterc2e57236-f184-4fa8-8fd5-c44cbf2300582026-07-01WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.557477a2-def8-740b-e063-6294a90ad2872026-06-30WarningsExact identifier
application number: M020
HealthyDerm tallow mineral sunscreen SPF50ZINC OXIDE 25%VIRENTIA LLC557b0b1f-8cd9-735a-e063-6294a90ad60e2026-06-30WarningsExact identifier
application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
application number: M020
Christian Dior Invisible UV Stick Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEParfums Christian Dior8e3840b2-b404-474f-aff7-dec3a64a70a42026-06-29WarningsExact identifier
application number: M020
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
application number: M020
Sun Bum Coconut Lip 30 Sunscreen Lip BalmAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d942fa-93de-45a8-e063-6294a90a2b492026-06-29WarningsExact identifier
application number: M020
AVON ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDETHE AVON COMPANY54f7c1d1-acdb-fd25-e063-6294a90a81732026-06-29WarningsExact identifier
application number: M020
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.55364026-c55a-b370-e063-6294a90ae0d12026-06-27WarningsExact identifier
application number: M020
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
application number: M020
ORLASKIN HYDRATING SUNSCREEN SPF 50OCTOCRYLENE ETHYLHEXYL METHOXYCINNAMATE ETHYLHEXYL SALICYLATE AVOBENZONEGuangzhou Yapheon Health Industry Co., Ltd.552b4c87-4621-d5a7-e063-6294a90a042e2026-06-26WarningsExact identifier
application number: M020
Bath and Body Works SPF Waikiki Beach CoconutAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c30de8a-4d29-bbac-e063-6294a90a84d92026-06-26WarningsExact 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