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 |
|---|---|---|---|---|---|---|
| Safe Sea SPF sport 65 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 0ed3242b-ac35-4d98-a777-1e44bb32a467 | 2025-12-08 | Warnings | M020 |
| Safe Sea SPF 50 | HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE | NIDARIA TECHNOLOGY LTD | 46641a33-d658-4ef0-9b7a-062adc401dde | 2025-12-08 | Warnings | M020 |
| Skin Filter Glow SPF | ZINC OXIDE | MALORIE MILES | 36485f44-a6bd-9529-e063-6294a90af7a4 | 2025-12-08 | M020 | |
| Skin Filter Matte SPF | TITANIUM DIOXIDE, ZINC OXIDE | MALORIE MILES | 3647f983-9e75-8955-e063-6294a90af162 | 2025-12-08 | M020 | |
| Body-Screen | ZINC OXIDE | MALORIE MILES | 36499be5-d680-92bf-e063-6394a90a89db | 2025-12-08 | M020 | |
| Skin Filter Matte SPF | TITANIUM DIOXIDE, ZINC OXIDE | MALORIE MILES | 3649f758-e31b-3c6a-e063-6294a90a5c36 | 2025-12-08 | M020 | |
| Body-Screen | ZINC OXIDE | MALORIE MILES | 364ae392-480a-14ea-e063-6394a90a3883 | 2025-12-08 | M020 | |
| Personalized Moisturizer SPF 30 | ZINC OXIDE 10.00% | Proven Skincare | d3cf8f81-d6ae-4570-ad86-43415e973e13 | 2025-12-08 | Warnings | M020 |
| GLOW SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2f9d087c-b2b3-5654-e063-6294a90a94e5 | 2025-12-08 | Warnings | M020 |
| MATTE SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2faee7ef-fc0c-6d01-e063-6294a90a6d68 | 2025-12-08 | Warnings | M020 |
| GLOW SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2faf530d-5574-b702-e063-6294a90ad6fd | 2025-12-08 | Warnings | M020 |
| MATTE SHIELD SPF | ZINC OXIDE | ACNE SOLUTIONS NYC INC | 2fb00db0-4c37-56c6-e063-6294a90a8aff | 2025-12-08 | Warnings | M020 |
| Matte Shield SPF | TITANIUM DIOXIDE, ZINC OXIDE | ACNE SOLUTIONS NYC INC | 3bb582ec-71e7-4ad8-e063-6394a90a94d4 | 2025-12-08 | Warnings | M020 |
| SPF 101 Lightly Tinted | ZINC OXIDE | The Acne Lab LLC | 334afdc8-1e12-d787-e063-6294a90aed7c | 2025-12-08 | M020 | |
| SPF 101 Non-Tinted | ZINC OXIDE | The Acne Lab LLC | 334bf8ea-2485-84e8-e063-6294a90aefa6 | 2025-12-08 | M020 | |
| SPF 101 Lightly Tinted | ZINC OXIDE | The Acne Lab LLC | 334d694a-f9e4-ae86-e063-6394a90abfe1 | 2025-12-08 | M020 | |
| SPF 101 Non-Tinted | ZINC OXIDE | The Acne Lab LLC | 334e32a4-c3a5-e37d-e063-6294a90ad6cf | 2025-12-08 | M020 | |
| Mineral Based Sunscreen Stick Non-Tinted | TITANIUM DIOXIDE, ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3245561d-a90c-7bf0-e063-6394a90ab3b6 | 2025-12-08 | M020 | |
| Mineral Based Sunscreen Stick Tinted | TITANIUM DIOXIDE, ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3245c1f7-2c1b-b6ad-e063-6394a90aaee6 | 2025-12-08 | M020 | |
| Mineral Based Facial Sunscreen | ZINC OXIDE | KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION | 3e8981ed-5847-7009-e063-6394a90a49a1 | 2025-12-08 | 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 |