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 |
|---|---|---|---|---|---|---|
| Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Kenvue Brands LLC | 4ce63abb-e716-40de-e063-6394a90a6e76 | 2026-03-15 | Warnings | M020 |
| GOODAL HEARTLEAF SOOTHING MOISTURE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CLIO COSMETICS Co., Ltd. | 8d147089-709f-4468-a47d-9251e737c9a4 | 2026-03-15 | Warnings | M020 |
| Cay Skin Isle Lip Balm SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Cay Skin, Inc. | d92a17c4-9827-5fb1-e053-2a95a90a9ca1 | 2026-03-13 | Warnings | M020 |
| DAILY FACE SUNSCREEN Broad Spectrum SPF 30 | ZINC OXIDE | Lilyana Naturals LLC | e5f53e2f-6566-4eac-b9b5-7697abaf044b | 2026-03-13 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Nice-Pak Products, LLC | af052521-bfa6-4142-a10b-ef51f474a077 | 2026-03-13 | Warnings, Adverse reactions | M020 |
| Moisturizing Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Nice-Pak Products, LLC | 42647444-93a3-4d2c-9bfc-91621fd098f7 | 2026-03-13 | Warnings, Adverse reactions | M020 |
| Sunscreen for Babies SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE | Nice-Pak Products, LLC | a4b9d7c0-dc09-4f0e-8b65-90ba180552bf | 2026-03-13 | Warnings, Adverse reactions | M020 |
| TINTED WATERY SUNSCREEN | TITANIUM DIOXIDE, ZINC OXIDE | KSISTERS PTE. LTD. | 4ced53d0-8bfc-ff8e-e063-6294a90a9dbd | 2026-03-13 | Warnings | M020 |
| Round Lab Birch Juice Mother s Day Gift Set | AVOBENZONE, HOMOSALATE, OCTISALATE | SEORIN COMPANY Co., Ltd. | 4cf03092-7886-ffa1-e063-6294a90a2aad | 2026-03-13 | Warnings | M020 |
| Daily Moisturizing Mineral Sunscreen | BROAD SPECTRUM SPF30 | EDINA PLASTIC SURGERY,LTD. | 4d056e2b-5813-da42-e063-6294a90ac519 | 2026-03-13 | Warnings | M020 |
| La Roche Posay Anthelios Sunscreen SPF 60 Ultra light | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | L'Oreal USA, Inc. | dad00eee-92cd-7610-e053-2a95a90a1fac | 2026-03-13 | Warnings | M020 |
| VITARAN REJUVENA SUNCARE | ALLANTOIN, AVOBENZONE, HOMOSALATE, OCTISALATE | BR PHARM CO. , Ltd. | 4cb7af72-49f6-0738-e063-6394a90a79eb | 2026-03-12 | Warnings | M020 |
| MIZON SNAIL REPAIR INTENSIVE BB No. 21 | ZINC OXIDE, OCTISALATE, OCTOCRYLENE | PFD Co.,Ltd. | 4cd0a8a7-11aa-e168-e063-6394a90a2ff2 | 2026-03-12 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Vi-Jon, LLC | 3da4706e-7c1a-435e-9603-e9aa98432018 | 2026-03-12 | Warnings, Adverse reactions | M020 |
| Sunscreen SPF50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Nice-Pak Products, LLC | 53806657-7b4d-45ff-a75b-9340dcd8140e | 2026-03-12 | Warnings, Adverse reactions | M020 |
| Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Nice-Pak Products, LLC | 08237b4c-4e5c-4b12-9510-2f8d64ab7f3a | 2026-03-12 | Warnings, Adverse reactions | M020 |
| SunnyDays Broad Spectrum SPF 30 Tinted Sunscreen 5 Fairfax | ZINC OXIDE | Tower 28 | 108851ac-3812-4c02-a04a-9f9a7f529ed6 | 2026-03-12 | Warnings | M020 |
| DIY Booster SPF 30 Facial Serum Unscented | OCTINOXATE, OCTISALATE, AVOBENZONE, AND ZINC OXIDE | Andalou naturals | ebaf5ef7-84aa-4cb1-a701-2e0d0fd357df | 2026-03-12 | Warnings | M020 |
| Vacation SPF 50 Classic | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Vacation INC. | f268fb1c-d7c2-f2f9-e053-2995a90a9e22 | 2026-03-12 | Warnings | M020 |
| Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440C | TITANIUM DIOXIDE | Kenvue Brands LLC | 4c335d9c-40ca-c0ce-e063-6394a90ac20a | 2026-03-11 | 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 |