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 | 2026-10-27 | ||
| excluded package | package | 58443-0589 | 58443-0589-4 | I | Inactivated by FDA | 2026-10-27 |
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 |
|---|---|---|---|---|---|---|
| Ray Defense Broad Spectrum SPF 30 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements | 807db1ff-a64a-44e4-a786-f88cd4518433 | 2025-12-17 | Warnings | M020 |
| SPF 50 Face Sunscreen Bioelements | AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Bioelements, Inc | 981c7b3c-d7d6-483d-bf32-10d526be5b3f | 2025-12-17 | Warnings | M020 |
| Glow Oil SPF 50 Beach Flower | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Supergoop, LLC | 2a46d7d2-293f-5024-e063-6294a90a31aa | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f114022-daaa-1834-e063-6394a90afd1d | 2025-12-17 | Warnings | M020 |
| Coppertone Tanning Sunscreen SPF 8 | AVOBENZONE 2%, HOMOSALATE 5%, OCTISALATE 4.5%, OCTOCRYLENE 3% | Beiersdorf Inc | 0f113048-adfb-7d2a-e063-6294a90a2012 | 2025-12-17 | Warnings | M020 |
| Coppertone Oil Free and Shine Control Face Sunscreen SPF 45 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | f3d163b4-6774-4c2e-e053-2a95a90afd59 | 2025-12-17 | Warnings | M020 |
| Coppertone EveryTone Face Sunscreen SPF 55 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b12f39-778c-ecee-e063-6394a90afa24 | 2025-12-17 | Warnings | M020 |
| Skin On Skin BC Foundation SPF 40 - Fair Cool | OCTISALATE, HOMOSALATE, ZINC OXIDE | YENSA Beauty, LLC | 462e9a4a-ef28-0e0e-e063-6394a90ab4f8 | 2025-12-17 | Warnings | M020 |
| Mattifying Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | b27d7df0-3c84-4cc5-9ef3-07105311fed9 | 2025-12-17 | Warnings | M020 |
| Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40 | TITANIUM DIOXIDE, ZINC OXIDE | Galderma Laboratories, L.P. | 45d101be-2b88-4759-9ccc-556f5ec0553d | 2025-12-17 | Warnings | M020 |
| Brightening Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | a42d6761-47cd-4c9b-9656-64e37e065639 | 2025-12-17 | Warnings | M020 |
| Avail Body with Sunscreen | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Emeis Cosmetics Pty Ltd | 4bb39ea1-f948-4357-b425-0cafd454ce30 | 2025-12-17 | Warnings | M020 |
| Bronzing Primer SPF 20 | TITANIUM DIOXIDE AND ZINC OXIDE | Colorescience | f749af07-0fcd-4376-be62-7c078b3e7eb6 | 2025-12-17 | Warnings | M020 |
| Miffy Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 98a2906d-61e2-4627-a695-a20f10872f9a | 2025-12-16 | Warnings | M020 |
| Dear Sun Tone Perfecting SPF Cushion | HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE | RBGROUP Co., Ltd | 80748647-e0ea-46dc-8ee2-a0ad77c4b19d | 2025-12-16 | Warnings | M020 |
| SUNSCREEN Stick | ZINC OXIDE 15%, TITANIUM DIOXIDE 8%, HOMOSALATE 6% | Foshan Sugar Max Cosmetics CO.,Ltd | 460e1038-30f0-a6e4-e063-6394a90ad534 | 2025-12-16 | Warnings | M020 |
| SUNSCREEN SPRAY150ml | ZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4% | Foshan Sugar Max Cosmetics CO.,Ltd | 460ead6c-dd44-e320-e063-6294a90a2b64 | 2025-12-16 | Warnings | M020 |
| Sunscreen Cream | ZINC OXIDE 12%,TITANIUM DIOXIDE 8%, HOMOSALATE 12%, OCTISALATE4.5%,PHENYLBENZIMIDAZOLE SULFONIC ACID 3.5% | Foshan Sugar Max Cosmetics CO.,Ltd | 460f0ca0-9440-9a6e-e063-6394a90a33b3 | 2025-12-16 | Warnings | M020 |
| Unseen Sunscreen Lip Protector SPF 30 | OCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE | Supergoop LLC | db12a89f-5fef-1b2a-e053-2a95a90a56f9 | 2025-12-16 | Warnings | M020 |
| Tinted Mineral Sunscreen | ZINC OXIDE | Natur LLC | 365f3c48-15a6-2d32-e063-6394a90aad78 | 2025-12-16 | 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 |