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.
| 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 |
|---|---|
| ZINC OXIDE | 223 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 59ea43e3-f6e6-4d10-9d8f-2f14eaf2f79b | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | 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 | 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 | 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.
Packages#
| 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 |