ALOE KOTE
- Product NDC
- 61477-225
- 11-digit product format
- 614770225
- Labeler code
- 61477
- Product ID
- 61477-225_495014ec-e473-983c-e063-6294a90a4c89
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE, OXYBENZONE, HOMOSALATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Aloe Care International, LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-05-17
- Substance
- OCTINOXATE; HOMOSALATE; OXYBENZONE
- Active strength
- 7.4; 14.5; 5.9 g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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 |
|---|---|---|---|---|---|
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 61477-225-11 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 61477-225-11 | bd6a592717d7… | 303034d00443… |
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
- ALOE KOTE
- Brand name suffix
- SPF 25
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 7.4 g/100g |
| HOMOSALATE | 14.5 g/100g |
| OXYBENZONE | 5.9 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 12e78c53-ba19-4c8e-bd2f-8c85fccbc179 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-02-13 | ALOE UP - ALOE KOTE SPF-25 (61477-225) |
| 2024-01-30 | ALOE UP - ALOE KOTE SPF-25 (61477-225) |
| 2022-04-14 | ALOE UP - ALOE KOTE SPF-25 (61477-225) |
| 2022-01-28 | ALOE UP - ALOE KOTE SPF-25 (61477-225) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61477-225-11 | ALOE KOTESPF 25 | 7 g in 1 JAR | CREAM | 7 | 7 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| UV Defense me. Matte Airy-Fit Sunscreen | ZINC OXIDE | MAGNIF CO., LTD | 459f2b8d-453c-4dee-e063-6394a90a4509 | 2025-12-10 | Warnings | M020 |
| RoC Hydration Plus SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | 45a3e250-8195-344d-e063-6294a90ae681 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION HYDRATE AND PLUMP DAILY MOISTURISER SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | bf3c1474-e353-63a5-e053-2a95a90a9b26 | 2025-12-10 | Warnings | M020 |
| ROC MULTI CORREXION EVEN TONE LIFT DAILY MOISTURIZER SPF30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Roc Skincare | f161d754-0c32-2fbe-e053-2a95a90a6b47 | 2025-12-10 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 35N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242ff053-b8c0-4f90-e063-6294a90a7bb3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 13 IVORY | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247ef1f8-ad12-4f80-e063-6394a90a3e3c | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e810d366-0c32-5b1c-e053-2a95a90a622e | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242b7d0e-82d8-793c-e063-6294a90a4aa3 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | eb744367-f318-e1e2-e053-2a95a90a2cc4 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 242faaed-e85a-a1d7-e063-6294a90aea92 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247d6c0e-8f88-faf0-e063-6394a90a10da | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1e9a5c77-7027-3b52-e063-6394a90ac0eb | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | e8241828-17b2-96c5-e053-2a95a90a12e5 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 1176181b-1331-ba68-e063-6394a90a961a | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247b56ad-4b61-8b6f-e063-6394a90af3b6 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 31N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 247afcae-855e-3f69-e063-6394a90a4231 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 41N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 24306304-4d0d-c5f0-e063-6394a90afad5 | 2025-12-09 | Warnings | M020 |
| AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN TWIN PACK | OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE | Aekyung Industrial Co., Ltd. | 1f9c7718-6fde-236c-e063-6394a90afa19 | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3482855b-de85-a5a7-e063-6294a90a55ae | 2025-12-09 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N PACK OF 2 | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 3483e7e6-b301-136d-e063-6294a90aba18 | 2025-12-09 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61477-225-11 | 61477022511 | 7 g in 1 JAR (61477-225-11) | 7 g | 2019-05-17 | 0000-00-00 | No | No | Current |