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 | 2026-10-21 | ||
| excluded package | package | 58443-0589 | 58443-0589-4 | I | Inactivated by FDA | 2026-10-21 |
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 |
|---|---|---|---|---|---|---|
| Naturalessa SPF50 Moisturizer | ZINC OXIDE | Audrey Morris Cosmetics International, LLC | 816ddfa1-cb55-4591-a90b-71631cb17626 | 2026-02-26 | Warnings | M020 |
| UV DEFENSE FACE MINERAL SPF 50 | ZINC OXIDE | BETTER INVENTION LTD | 4b9a9efe-9aba-0ed0-e063-6394a90a2c6b | 2026-02-26 | Warnings | M020 |
| MISTINE UV DEFENSE FACE SUNSCREEN SPF50 | AVOBENZONE, HOMOSOLATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9043-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | BETTER INVENTION LTD | 4b9a8f28-9041-8fb7-e063-6294a90a34d3 | 2026-02-26 | Warnings | M020 |
| Rationale The Discovery Travel Kit | ZINC OXIDE | RATIONALE GROUP PTY LTD | 0c919aea-4bd4-427e-97e7-9c153b42f491 | 2026-02-25 | Warnings | M020 |
| Kiss My Face Purely Mineral Daily 50 Sunscreen SPF 50 | ZINC OXIDE | Windmill Health Products, LLC | ebfb149c-0371-4492-b03a-5fdcb7821753 | 2026-02-25 | Warnings | M020 |
| SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY | OCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDE | SHISEIDO AMERICAS CORPORATION | c05cef12-a6a7-4682-9357-6d77f4ca3267 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE Protective Day | AVOBENZONE, OCTINOXATE, OCTOCRYLENE | Shiseido Americas Corporation | dea8e4c1-6a9c-44c6-abc8-6cdd50f35f49 | 2026-02-25 | Warnings | M020 |
| Aura Defense | ZINC OXIDE | Grace and Glow MD LLC | 4ba75eff-74ef-278b-e063-6394a90a8ef0 | 2026-02-25 | Warnings | M020 |
| AM Shield plus | ZINC OXIDE | Grace and Glow MD LLC | 4ba7c282-c68e-8719-e063-6394a90a3814 | 2026-02-25 | Warnings | M020 |
| cle de peau BEAUTE RADIANT FOUNDATION N M I10 | OCTINOXATE AND TITANIUM DIOXIDE | Shiseido Americas Corporation | 3be1fe06-bd3b-4078-bee9-d3caf8d068ff | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4babe2ab-c5da-9a83-e063-6294a90aee4c | 2026-02-25 | Warnings | M020 |
| Daily Facial Moisturizer SPF 25 | SUNSCREEN | Person and Covey | 6b9258e4-c7c6-765e-e053-2991aa0a9f4e | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac1c33-36fe-8d29-e063-6394a90a32a5 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bac5550-c45f-a738-e063-6394a90ae5c8 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4baca374-7aaa-8d1d-e063-6394a90a5a55 | 2026-02-25 | Warnings | M020 |
| Jack Black | AVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUM | Jack Black L.L.C. | 4bad1502-bc44-54ec-e063-6294a90ace8b | 2026-02-25 | Warnings | M020 |
| Truskin SPF 30 Mineral Sunscreen Facial Serum | ZINC OXIDE | Allure Labs | 2e20c132-8a03-1d5d-e063-6394a90ad2c3 | 2026-02-25 | Warnings | M020 |
| Rationale The Brilliance Tinted Serum SPF 50 | ZINC OXIDE | RATIONALE GROUP PTY LTD | 5c38506b-1533-435f-87a6-0452bae5b29f | 2026-02-24 | Warnings | M020 |
| FULLY RICE CERAMIDE MOISTURE SUNSCREEN | ZINC OXIDE | Adapt Inc. | d8bfe222-3184-4c98-9876-ef5ac81772b6 | 2026-02-24 | 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 |