MKRS
- Product NDC
- 13630-0091
- Requested package NDC
- 13630-0091-4
- 11-digit product format
- 136300091
- Labeler code
- 13630
- Product ID
- 13630-0091_e1f7b435-c0f8-2220-e053-2a95a90a9d47
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
- Dosage form
- AEROSOL, SPRAY
- Route
- TOPICAL
- Labeler
- Prime Packaging, Inc.
- Application
- M020
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-08-01
- Marketing end
- 2022-06-30
- Substance
- AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
- Active strength
- 29 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 package | package | 13630-0091 | 13630-0091-4 | D | Discontinued by firm | 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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| UNME SOULMA CENTELLA and BEEF TALLOW SUNSCREEN | ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, ZINC OXIDE, PHENYLBENZIMIDAZOLE SULFONIC ACID | Shenzhen Jufeng Qiyuan Trading Co., Ltd. | 4c1a3345-58c1-93c8-e063-6394a90a865e | 2026-03-03 | Warnings | M020 |
| Botnia Gentle Sun SPF 30 | ZINC OXIDE | Botnia, Inc | 005d0245-fe53-47e5-888b-683f58cd6d26 | 2026-03-03 | Warnings | M020 |
| Broad Spectrum Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 64534ec3-396c-4c11-9ec1-e2615f7e24b1 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 9b7249e4-4c1f-40e7-a657-d40c53d9317f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | SUNSCREEN | Old East Main Co. | 1673b8b1-08ad-40a5-8180-93333a8edb67 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 32036e41-2414-4498-8e1c-61511abf7a32 | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sport Sunscreen SPF 100 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42266fa5-5f30-2a9f-e063-6394a90a1dfe | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Amazon.com Services LLC | d4b4ebac-c6c2-474b-afc6-b80b8431e90f | 2026-03-03 | Warnings, Adverse reactions | M020 |
| Fruit Snack SPF 15 Broad Spectrum Lip Balm | FRUIT SNACK SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | 24c2a9fc-892b-c74d-e063-6394a90af62c | 2026-03-03 | Warnings | M020 |
| Olay Complete plus Principle Invisible Facial Primer plus Sunscreen Broad Spectrum SPF 35 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 4c231aa1-75eb-c171-e063-6294a90a8b8b | 2026-03-03 | Warnings | M020 |
| SPF 30 Mineral Sunscreen | ZINC OXIDE | Smalls Brand LLC DBA Roe Wellness | 4c25b4ec-b045-7066-e063-6294a90ab801 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin Daily Lip Sun Gloss SPF 30 Iced Coffee | ZINC OXIDE | Good Weather Inc. | 4c261e88-7f37-2361-e063-6294a90aa602 | 2026-03-03 | Warnings | M020 |
| Good Weather Skin All Over Sun Milk Face and Body SPF 50 | ZINC OXIDE | Good Weather Inc. | 4c278acc-7cd5-0d85-e063-6394a90a3a72 | 2026-03-03 | Warnings | M020 |
| Lekura - ZincDaily Natural Face Sunscreen SPF50 | ZINC OXIDE SUNSCREEN | VEGANIC SKN LIMITED | 4c2bed23-f77b-2c97-e063-6394a90a4ca5 | 2026-03-03 | Warnings | M020 |
| NEOGEN DERMALOGY DAY-LIGHT PROTECTION AIRY SUNSCREEN BROAD SPECTRUM SPF 50 | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | OUTIN FUTURES CO.,LTD. | 4ddce1f0-44a3-7e0c-e063-6294a90a3f7d | 2026-03-03 | Warnings | M020 |
| Bephor Reviving Suncream SPF50 | ETHYLHEXYL METHOXYCINNAMATE, HOMOSALATE, ZINC OXIDE | Gyeongbuk Institute of IT Convergence Industry Technology | 4c055b22-94e9-ff0d-e063-6394a90ab2ec | 2026-03-02 | Warnings | M020 |
| Bath and Body Works SPF At The Beach | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c315bdb-dc33-1737-e063-6294a90a31a4 | 2026-03-02 | Warnings | M020 |
| Bath and Body Works SPF Tahiti Isle | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 38d02c8d-cdc8-b8d6-e063-6294a90ad9e4 | 2026-03-02 | Warnings | M020 |
| Sport | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATE | Old East Main Co. | a460e512-f268-4941-beb6-29df10fdbb3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Tanning Sunscreen SPF 15 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42258ebe-e3cc-4d70-e063-6294a90a9651 | 2026-03-02 | Warnings, Adverse reactions | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 13630-0091-4 | 13630009104 | 177 mL in 1 CAN (13630-0091-4) | 177 ml | 2015-08-01 | 2022-06-30 | No | No | Current |