Austalian Gold
- Product NDC
- 58443-0589
- 11-digit product format
- 584430589
- Labeler code
- 58443
- Product ID
- 58443-0589_ed9e76ff-2bd8-172c-e053-2995a90a198a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Octisalate, Avobenzone, Octocrylene, Homosalate
- Dosage form
- SPRAY
- Route
- TOPICAL
- Labeler
- Prime Enterprises Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2019-10-30
- Marketing end
- 0000-00-00
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
- Active strength
- 30 g/mL; g/mL; g/mL; g/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 58443-0589 | I | Inactivated by FDA | 2026-10-23 | ||
| excluded package | package | 58443-0589 | 58443-0589-4 | I | Inactivated by FDA | 2026-10-23 |
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 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 58443-0589-4 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 58443-0589-4 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 58443-0589-4 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 58443-0589-4 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 58443-0589-4 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 58443-0589-4 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 58443-0589-4 | 302b2466d912… | e7b80fea0513… |
| 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 | 58443-0589-4 | 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 | 58443-0589-4 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 58443-0589-4 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 58443-0589-4 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 58443-0589-4 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 58443-0589-4 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 58443-0589-4 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 58443-0589-4 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58443-0589-4 | 2024-01-30 | C162847 | 48780-1 | 1030e365-3e1d-111a-e063-dadaa90a10e2 | Australian Gold Instant Bronzer Spray Gel Broad Spectrum SPF 30 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58443-0589-4 | Austalian GoldBroad Spectrum SPF 30 Sunscreen | 237 mL in 1 BOTTLE, SPRAY | SPRAY | 237 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58443-0589 | AUSTALIAN GOLD BROAD SPECTRUM SPF 30 SUNSCREEN (OCTISALATE, AVOBENZONE, OCTOCRYLENE, HOMOSALATE) SPRAY [PRIME ENTERPRISES INC.] | 1 | Legacy NDC, 1 package rows | 20221119_ed9e76ff-2bd7-172c-e053-2995a90a198a.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 |
|---|---|---|---|---|---|---|
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | cc5dafd4-dfd4-d310-e053-2995a90a82a8 | 2025-12-31 | Warnings | M020 |
| Coppertone EveryTone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | 04c58384-fd82-f6d0-e063-6294a90a3ff1 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdort Inc | cc46b3a3-48f5-4593-e053-2995a90a8782 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sport SPF 60 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23fb7304-789d-1f94-e063-6394a90a7e62 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | cbf9a785-f218-76fb-e053-2995a90a8e03 | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Hydragel Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60c2a38-ef92-0dff-e053-2995a90a47c4 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | (TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a5370-ec6f-42a7-e063-6394a90ac37c | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d53e1253-f6a4-4f3d-e053-2a95a90a79ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Face SPF 60 Plus Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b36eb1-bffc-c31e-e063-6294a90a8eb3 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d47460a1-4768-ee44-e053-2a95a90adecf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 50 | ZINC OXIDE 20% | Beiersdorf Inc | d46359e7-b585-c43a-e053-2995a90a0863 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d473e7ed-4a9f-76fe-e053-2995a90ab37d | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | f3e3f4c6-2cb9-7b17-e053-2a95a90a3854 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Age Defense Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23f88c88-b68e-4706-e063-6294a90afb38 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d473113d-2fc3-6b1c-e053-2a95a90a88ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% | Beiersdorf Inc | d89df7a5-7741-3e1d-e053-2995a90ae275 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d475e14f-dab1-dec5-e053-2995a90aef73 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d4757d99-bac6-48fb-e053-2a95a90ab1bf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 24d3fbbc-0bce-b47a-e063-6394a90a9afa | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Light | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58443-0589-4 | 58443058904 | 237 mL in 1 BOTTLE, SPRAY (58443-0589-4) | 237 ml | 2019-10-30 | 0000-00-00 | No | No | Current |