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 | 2026-10-21 |
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 | 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 |
|---|---|---|---|---|---|---|
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 31177bbd-68b0-8b24-e063-6294a90aa8d8 | 2025-12-10 | Warnings | M020 |
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 3117e138-83a1-0931-e063-6394a90abe43 | 2025-12-10 | Warnings | M020 |
| SHADED | TITANIUM DIOXIDE, ZINC OXIDE | Potency No. 710 LLC | 31188175-a4ca-449f-e063-6394a90a3c05 | 2025-12-10 | Warnings | M020 |
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3118c3ed-f0f0-f997-e063-6294a90a53a9 | 2025-12-10 | Warnings | M020 |
| COVERED | ZINC OXIDE | Potency No. 710 LLC | 3117faeb-1792-1b2e-e063-6294a90a92df | 2025-12-10 | Warnings | M020 |
| Non-Tinted Mineral Foaming Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Restore Skin Therapy, LLC | 364b6af2-a0ed-4a17-e063-6394a90a3a17 | 2025-12-10 | M020 | |
| Morning Replenish | ZINC OXIDE | Restore Skin Therapy, LLC | 364b26c2-a1bb-9660-e063-6294a90a14d1 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Tinted | ZINC OXIDE | Fleur de Lune, LLC | 34288989-35b8-3aa3-e063-6394a90ac2c4 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Tinted | ZINC OXIDE | Fleur de Lune, LLC | 3418394b-fede-65ce-e063-6394a90ad5f9 | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Non-Tinted | ZINC OXIDE | Fleur de Lune, LLC | 341871e5-c170-7560-e063-6394a90a8eee | 2025-12-10 | M020 | |
| Glass Skin Sunscreen Non-Tinted | ZINC OXIDE | Fleur de Lune, LLC | 3428bdbb-1f18-a29b-e063-6294a90addbc | 2025-12-10 | M020 | |
| Sheer Facial Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342b2403-4f4a-3e77-e063-6294a90a4f0a | 2025-12-10 | M020 | |
| Sheer Mineral Sunscreen Bar | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342b69d5-f0e1-99cd-e063-6294a90abb6e | 2025-12-10 | M020 | |
| Sheer Facial Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | BB MEDICAL & DERMATOLOGY INC | 342c3f42-c17f-f777-e063-6394a90a8058 | 2025-12-10 | M020 | |
| Lip SPF | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396d3fdd-99d8-77e8-e063-6294a90aec2f | 2025-12-10 | M020 | |
| Non-Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396cae82-7641-e1b2-e063-6394a90a7c07 | 2025-12-10 | M020 | |
| Solar Knight SPF 40 Broad Spectrum | TITANIUM DIOXIDE, ZINC OXIDE | MASCARENAS ENTERPRISES, INC. | 36c27c91-22ac-205c-e063-6294a90ab379 | 2025-12-10 | M020 | |
| Tinted Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | FRANCISCO FLORES, M.D., P.A. | 396ce15a-06ad-4055-e063-6294a90a27fb | 2025-12-10 | M020 | |
| Dermablue Daily Replenishing | ZINC OXIDE | Dermablue, P.C. | 308da9c9-544e-d5d1-e063-6294a90aa49b | 2025-12-10 | Warnings | M020 |
| Recoverie Mineral Matte | ZINC OXIDE | Clear Day Acne Clinic | 308f41de-fb14-40f9-e063-6394a90a008f | 2025-12-10 | 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 |