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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SHISEIDO URBAN ENVIRONMENT VITA-CLEAR SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | 60e55ebb-47b8-465e-819a-af195952e1ca | 2026-02-04 | Warnings | M020 |
| SHISEIDO BENEFIANCE NUTRIPERFECT DAY | AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE | SHISEIDO AMERICAS CORPORATION | f644c67b-3a71-411b-b321-39a8b18af0c7 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE UV PROTECTIVE N | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 4b242b76-8aed-4939-9906-741828acd815 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | efcf240f-95cb-45e0-b58a-9c8f3609aa55 | 2026-02-04 | Warnings | M020 |
| cle de peau BEAUTE PORE-REFINING MATTIFYING VEIL | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE | Shiseido Americas Corporation | 270ecc83-4262-4102-a753-2acaf11360a0 | 2026-02-04 | Warnings | M020 |
| Walgreens 50 Caramel and Pistachio Scented Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALGREEN COMPANY | 4a038017-9f15-b4b2-e063-6294a90a1b23 | 2026-02-04 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTOR | OCTISALATE, OCTOCRYLENE, ZINC OXIDE | Shiseido Americas Corporation | ce6a28c1-56e6-4105-bc9d-9d1986ead420 | 2026-02-04 | Warnings | M020 |
| Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | d52e2c61-edbc-4c26-b1a7-e8eb656db188 | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | d365ed6d-a92f-473b-be19-b8b63d17f3b7 | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | 0a3b4597-06fe-4689-9751-6577867d755e | 2026-02-04 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | HARRIS TEETER | b83ea476-fa32-4405-9ae3-f294836edb62 | 2026-02-04 | Warnings | M020 |
| Sunplus SPF50 Face Body Sunscreen | SUNSCREEN | I.Shay Cosmetics | 26d55baf-66dc-b1b8-e063-6394a90a670d | 2026-02-04 | Warnings | M020 |
| NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Angel Glow | ZINC OXIDE SUNSCREEN | Bentley Laboratories, LLC | 351217c4-8d71-41d9-ab08-c43857c0510c | 2026-02-04 | Warnings | M020 |
| NIDA Invisible Fit Sun Stick | SUN STICK | Proso Corp | 49eca4f2-aae3-a0d5-e063-6394a90ab25f | 2026-02-03 | Warnings | M020 |
| Shiny Hiny SPF 45 Mineral Sunscreen | ZINC OXIDE | Shiny Hiny Products, LLC | 31adde36-5e1b-40ff-e063-6294a90a6f2e | 2026-02-03 | Warnings | M020 |
| Walgreens 50 Passion Fruit Scented Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | WALGREEN COMPANY | 49f030d8-959c-a3cd-e063-6294a90ae1ba | 2026-02-03 | Warnings | M020 |
| Zealios Mineral SPF 30 Sunscreen | ZINC OXIDE | Personal Best Products Inc. dba Zealios | c421b00c-6536-4455-81f6-01686f8c2388 | 2026-02-03 | Warnings | M020 |
| Zealios Sport Performance Ultralight SPF 50 Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Personal Best Products Inc. dba Zealios | 020bd1b4-da50-4117-a4f3-b74aa4187396 | 2026-02-03 | Warnings | M020 |
| Adrien Arpel Daily Defense Moisturizer SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Color Me Beautiful Inc | f65e1428-b79a-4126-862a-907ca17ee8f7 | 2026-02-02 | Warnings | M020 |
| Flori Roberts Daily Defense Moisturizer SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | Color Me Beautiful Inc | 934d6b80-0cc3-4dcd-a25d-2191bd273618 | 2026-02-02 | Warnings | M020 |
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 |