ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25
- Product NDC
- 13537-937
- 11-digit product format
- 135370937
- Labeler code
- 13537
- Product ID
- 13537-937_325ddb79-23ba-4f93-e063-6394a90a3938
- 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
- 2014-09-30
- Substance
- OCTINOXATE; OXYBENZONE
- Active strength
- .066; .015 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 | 13537-937 | 13537-937-44 | 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 | 13537-937-44 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 13537-937-44 | D | Discontinued by firm | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 | 13537-937-44 | 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 Highly Moisturizing and coloring SPF 25
- Brand name suffix
- (ROSA ROMANTICA FEMME) - PINK
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | .066 g/g |
| OXYBENZONE | .015 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 |
|---|---|
| aa79b1a4-6b33-47c9-b55e-b813d9b22265 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-937-44 | 2025-04-11 | C162847 | 48780-1 | 9d75b9d0-659e-f424-e053-dadaa90a57ce | ÉSIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 |
| 13537-937-44 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-659e-f424-e053-dadaa90a57ce | ÉSIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 13537-937-43 | ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25(ROSA ROMANTICA FEMME) - PINK | 4 g in 1 TUBE | LIPSTICK | 4 | 2 | |
| 13537-937-44 | ESIKA HYDRACOLOR 2 IN 1 Highly Moisturizing and coloring SPF 25(ROSA ROMANTICA FEMME) - PINK | 1 in 1 BOX | LIPSTICK | 1 | 2 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 13537-937 | ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (MARRON GLAMOUR) - BROWN (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO DESEO) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROJO INTRIGANTE FEMME) - RED (OCTINOXATE AND OXYBENZONE) LIPSTICK ESIKA HYDRACOLOR 2 IN 1 HIGHLY MOISTURIZING AND COLORING SPF 25 (ROSA ENCANTO FEMME) - PINK (OCTINOXATE AND OXYBENZONE) LIPSTICK [VENTURA CORPORATION LTD] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250413_aa79b1a4-6b33-47c9-b55e-b813d9b22265.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 |
|---|---|---|---|---|---|---|
| Coppertone Tanning Sunscreen SPF 15 | AVOBENZONE 2%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | cc5dafd4-dfd4-d310-e053-2995a90a82a8 | 2025-12-31 | Warnings | M020 |
| Coppertone EveryTone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | 04c58384-fd82-f6d0-e063-6294a90a3ff1 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdort Inc | cc46b3a3-48f5-4593-e053-2995a90a8782 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids Sport SPF 60 Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23fb7304-789d-1f94-e063-6394a90a7e62 | 2025-12-31 | Warnings | M020 |
| Coppertone Kids SPF 50 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | cbf9a785-f218-76fb-e053-2995a90a8e03 | 2025-12-31 | Warnings | M020 |
| Coppertone Glow Hydragel Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | b60c2a38-ef92-0dff-e053-2995a90a47c4 | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | (TO DELIVER) AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | 0a5a5370-ec6f-42a7-e063-6394a90ac37c | 2025-12-31 | Warnings | M020 |
| Coppertone Waterbabies Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d53e1253-f6a4-4f3d-e053-2a95a90a79ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Face SPF 60 Plus Sunscreen | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 04b36eb1-bffc-c31e-e063-6294a90a8eb3 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d47460a1-4768-ee44-e053-2a95a90adecf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 50 | ZINC OXIDE 20% | Beiersdorf Inc | d46359e7-b585-c43a-e053-2995a90a0863 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | d473e7ed-4a9f-76fe-e053-2995a90ab37d | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 9% | Beiersdorf Inc | f3e3f4c6-2cb9-7b17-e053-2a95a90a3854 | 2025-12-31 | Warnings | M020 |
| Coppertone Every Tone Age Defense Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 23f88c88-b68e-4706-e063-6294a90afb38 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 9%, OCTISALATE 4.5%, OCTOCRYLENE 8% | Beiersdorf Inc | d473113d-2fc3-6b1c-e053-2a95a90a88ed | 2025-12-31 | Warnings | M020 |
| Coppertone Sport Sunscreen SPF 30 | AVOBENZONE 3%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 6% | Beiersdorf Inc | d89df7a5-7741-3e1d-e053-2995a90ae275 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 50 | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 5% | Beiersdorf Inc | d475e14f-dab1-dec5-e053-2995a90aef73 | 2025-12-31 | Warnings | M020 |
| Coppertone Complete Sunscreen SPF 30 | AVOBENZONE 2%, HOMOSALATE 8%, OCTISALATE 4.5%, OCTOCRYLENE 7% | Beiersdorf Inc | d4757d99-bac6-48fb-e053-2a95a90ab1bf | 2025-12-31 | Warnings | M020 |
| Coppertone Sunscreen SPF 60 | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 10% | Beiersdorf Inc | 24d3fbbc-0bce-b47a-e063-6394a90a9afa | 2025-12-31 | Warnings | M020 |
| Sei Bella CC Brightening Creme Light | OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1% | Melaleuca Inc. | 6894b9d9-a5b5-4c98-e053-2991aa0a9ca2 | 2025-12-31 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 13537-937-43 | 13537093743 | 4 g in 1 TUBE | 4 g | Historical |
| 13537-937-44 | 13537093744 | 1 in 1 BOX | Historical |