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 |
|---|---|---|---|---|---|---|
| Round Lab Holiday Heroes Gift Set | AVOBENZONE, HOMOSALATE, OCTISALATE | SEORIN COMPANY Co., Ltd. | 5a0d3a85-caff-a90d-e063-6394a90ad045 | 2026-08-27 | Warnings | M020 |
| MELAO Hydrating Lightweight Sunscreen | AVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDE | Guangdong Aimu Biological Technology Co., Ltd | 59eeaea1-d726-99f3-e063-6394a90aeea3 | 2026-08-26 | Warnings | M020 |
| Hero Force Shield Superlight Sunscreen SPF 30 | ZINC OXIDE | Church & Dwight Co., Inc. | 140268a9-adb9-4574-ad82-4a2e924dc808 | 2026-08-26 | Warnings | M020 |
| Juyasuyon Sport Ultra Sunscreen Cream | OCTOCRYLENE,OXYBENZONE,AVOBENZONE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE | Guangdong Aimu Biological Technology Co., Ltd | 598cfe9e-6ebe-ad18-e063-6294a90ace22 | 2026-08-25 | Warnings | M020 |
| NeoStrata Sheer Hydration Sunscreen Broad Spectrum SPF 40 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | e8cdf9f7-d968-42b3-bcb8-02dee7717fd8 | 2026-08-25 | Warnings | M020 |
| JUYASUYON Sport Ultra Sunscreen | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Guangdong Aimu Biological Technology Co., Ltd | 59d97ee0-e416-53e7-e063-6294a90a9153 | 2026-08-25 | Warnings | M020 |
| NeoStrata Enlighten Skin Brightener with Sunscreen Broad Spectrum SPF 35 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | ed495f18-2f8e-4991-b797-82e9f6fc7acb | 2026-08-25 | Warnings | M020 |
| Q Skin Science | SUNSCREEN | International Cosmeceuticals, Inc | 59e4c3d0-ee4c-2350-e063-6394a90ac9d2 | 2026-08-25 | Warnings | M020 |
| ISNTREE HYALURONIC ACID WATERY SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ISNTREE Inc. | 59e9279a-2427-d6bc-e063-6394a90ae86e | 2026-08-25 | Warnings | M020 |
| Exuviance Age Reverse Day Repair with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, AND OCTISALATE | NeoStrata Company Inc. | 4739e678-ce51-4863-bb74-2275879e1b47 | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(YELLOW) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c3009b-ae16-52e1-e063-6394a90a69ee | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(PINK) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c68d9b-9aa9-4996-e063-6394a90a48d4 | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(GREEN) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c70c82-f7ff-9a04-e063-6294a90a7b3d | 2026-08-24 | Warnings | M020 |
| MELAO zinc stick(BLUE) | TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENE | Guangzhou Haishi Biological Technology Co., Ltd. | 59c78929-9df7-5212-e063-6394a90a3766 | 2026-08-24 | Warnings | M020 |
| Dr Marvel COLOR CHANGING FOUNDATION SPF30 | ETHYLHEXYL METHOXYCINNAMATE | Guangzhou Liyan Cosmetics Technology Co., Ltd. | 59c8865f-ccee-dd50-e063-6294a90aa185 | 2026-08-24 | Warnings | M020 |
| Exuviance Daily Corrector with Sunsreen Broad Spectrum SPF 35 | OCTINOXATE, OCTISALATE, AND AVOBENZONE | NeoStrata Company Inc. | 74a998e2-8ebf-436c-aac1-b456cd2e072d | 2026-08-24 | Warnings | M020 |
| Homosalate, Octisalate, Zinc oxide | HOMOSALATE, OCTISALATE, ZINC OXIDE | Aldi Inc | 59cbfb14-d9b1-ce93-e063-6394a90ac312 | 2026-08-24 | Warnings, Adverse reactions | M020 |
| SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01 | ZINC OXIDE, TITANIUM DIOXIDE | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 59d74e3f-e3fa-a7a9-e063-6294a90a76e5 | 2026-08-24 | Warnings | M020 |
| ISNTREE HYALURONIC ACID WATERY SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | ISNTREE Inc. | 59ac747a-f9c7-2c18-e063-6394a90a2306 | 2026-08-23 | Warnings | M020 |
| Sunski Sol Power Daily Face Sunscreen SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | Stewart Charley Ventures, LLC | b6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c | 2026-08-21 | 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 |