ESIKA HYDRACOLOR 2 IN 1 SPF 25
- Product NDC
- 13537-697
- 11-digit product format
- 135370697
- Labeler code
- 13537
- Product ID
- 13537-697_42f3fe19-b76f-2a12-e063-6394a90afd7f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE and OXYBENZONE
- Dosage form
- LIPSTICK
- Route
- TOPICAL
- Labeler
- Ventura Corporation LTD
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-12-18
- Substance
- OCTINOXATE; OXYBENZONE
- Active strength
- .0664; .0151 g/g; g/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | 13537-697 | 13537-697-24 | D | Discontinued by firm | 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 13537-697-24 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 13537-697-24 | I | Inactivated by FDA | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 13537-697-24 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
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
- ESIKA HYDRACOLOR 2 IN 1 SPF 25
- Brand name suffix
- (FUCSIA CAUTIVANTE EXOTIC) - PINK
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | .0664 g/g |
| OXYBENZONE | .0151 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 95OOS7VE0Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e1eb77f1-d65c-4af8-a7d9-90f10570960f | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2025-11-10 | ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25 |
| 2025-11-10 | ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25 |
| 2020-01-31 | ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25 |
| 2020-01-31 | ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING LIPSTICK SPF 25 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13537-697-23 | ESIKA HYDRACOLOR 2 IN 1 SPF 25(FUCSIA CAUTIVANTE EXOTIC) - PINK | 4 g in 1 TUBE | LIPSTICK | 4 | 4 | |
| 13537-697-24 | ESIKA HYDRACOLOR 2 IN 1 SPF 25(FUCSIA CAUTIVANTE EXOTIC) - PINK | 1 in 1 BOX | LIPSTICK | 1 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13537-697 | ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOUR) - BROWN (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO DESEO) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO INTRIGANTE) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (ROJO LUJURIA) - RED (OCTINOXATE AND OXYBENZON ....... HYDRACOLOR 2 IN 1 SPF 25 (FRAMBUESA MANIA EXOTIC) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (BORGONA SEXY EXOTIC) - PURPLE (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (MARRON GLAMOR EXOTIC) - BROWN (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 SPF 25 (OCTINOXATE AND OXYBENZONE) KIT [VENTURA CORPORATION LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20151218_e1eb77f1-d65c-4af8-a7d9-90f10570960f.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 |
|---|---|---|---|---|---|---|
| Invisible Sunscreen SPF 40 | HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE | PARTICLE AESTHETIC SCIENCE LTD | 1b33b4fb-1deb-69f7-e063-6294a90a9cc0 | 2025-11-19 | Warnings | M020 |
| Softlips Vanilla | DIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONE | The Mentholatum Company | 8dff782f-7201-4ad9-94d2-672058f817b8 | 2025-11-19 | Warnings | M020 |
| Illuminizing Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e36351-4caf-3393-e063-6394a90a00b1 | 2025-11-18 | Warnings | M020 |
| Perfecting Blendrops Broad Spectrum SPF 46 | HOMOSALATE, OCTISALATE, ZINC OXIDE | Wasatch Product Development, LLC | 43e454cf-dac8-4c2f-e063-6394a90a7097 | 2025-11-18 | Warnings | M020 |
| Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 Sunscreen | HOMOSALATE, OCTOCRYLENE, ZINC OXIDE | H.E.B. | 43e55eb7-6572-bd88-e063-6294a90aa7ee | 2025-11-18 | Warnings | M020 |
| ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Merle Norman Cosmetics, Inc. | d10272ea-aedd-5759-e053-2a95a90a3ab3 | 2025-11-18 | Warnings | M020 |
| DAYDREAM Broad Spectrum Sunscreen SPF 40 | ZINC OXIDE | Drmtlgy, LLC | bd0981cb-49ce-4eaf-bd9e-db48f56b7314 | 2025-11-18 | Warnings | M020 |
| SPF 25 LIP BALM | AVOBENZONE, OCTISALATE, HOMOSALATE | Drmtlgy, LLC | 8aed2fb0-f7b8-4ff0-b597-144c0557789e | 2025-11-18 | Warnings | M020 |
| Sunny Defense Sunscreen Stick | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 262450f0-c4a1-dcca-e063-6394a90ae3cd | 2025-11-17 | Warnings | M020 |
| Tone Blur Essence Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | RBGROUP Co., Ltd | 1814b5e7-5bbf-df16-e063-6294a90a96c4 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c48c66-bd5b-0024-e063-6394a90a6c7b | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c512da-e4b6-dd9c-e063-6294a90a1730 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c52258-2549-c42b-e063-6394a90a1526 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c59de6-8eb2-d00a-e063-6294a90a0b04 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5bd02-62e0-019a-e063-6294a90adcf3 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5d54e-119c-0c6d-e063-6394a90aba4c | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c5eb1c-b268-acfb-e063-6394a90ad4cc | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27C | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6157a-4b62-8279-e063-6294a90abe05 | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27W | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c6252f-56b8-9e3c-e063-6294a90aa12c | 2025-11-17 | Warnings | M020 |
| AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28N | OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE | Aekyung Industrial Co., Ltd. | 43c62e80-9ace-c1f2-e063-6294a90a5bfa | 2025-11-17 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 13537-697-23 | 13537069723 | 4 g in 1 TUBE | 4 g | Historical |
| 13537-697-24 | 13537069724 | 1 in 1 BOX | Historical |