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 99 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35Kinfield, Inc.0710db9f-fe91-4b98-a337-5fde33d98a9d2025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.1030c5a4-3067-48e6-a21c-0d327ef434d02025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.612c5730-c3b4-486e-8ce9-8a861f676fa82025-12-30WarningsExact identifier
application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum SunscreenKINFIELD LIPLOCK SUNSCREENKinfield, Inc.477aa1a2-c893-4750-84da-e5afe7ccd45b2025-12-30WarningsExact identifier
application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.cbdfd0ae-514b-4b53-98ad-4270163bd0df2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDECLINIQUE LABORATORIES LLC2397aca5-bf0a-619d-e063-6394a90a7ab92025-12-30WarningsExact identifier
application number: M020
Resource Essentials Sun Protection Mineral SPF 3014% ZINC OXIDESkinresource.md, L.L.C.45b486cf-28ee-6392-e063-6394a90affb02025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47320858-0aea-6ee9-e063-6294a90a9fa92025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light WarmOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47325530-b097-db9a-e063-6294a90a335d2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47328eb4-8ad7-28b5-e063-6294a90a20b12025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732bbec-d9f9-1639-e063-6394a90aff822025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732ecd0-5261-7f11-e063-6394a90a26f32025-12-30WarningsExact identifier
application number: M020
ScalpProtectionSpraySCALP PROTECTION SPRAYNaturich Labsc227ff3a-bbbb-5cc5-e053-2a95a90a8e322025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsExact identifier
application number: M020
SLMDAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONESkin PS Brands1aa36c01-21b5-f06e-e063-6294a90a608f2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - FairHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC473738b4-7c36-8edf-e063-6394a90ad24b2025-12-30WarningsExact 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