REPAIRWEAR
- Product NDC
- 49527-017
- 11-digit product format
- 495270017
- Labeler code
- 49527
- Product ID
- 49527-017_32c42bda-e70e-fc0b-e063-6394a90a8614
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- OCTINOXATE, OCTISALATE, and TITANIUM DIOXIDE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- CLINIQUE LABORATORIES LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-05-02
- Substance
- OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE
- Active strength
- 75; 35; 17 mg/mL; mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- 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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 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 | 49527-017-01 | 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 | 49527-017-01 | 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
- REPAIRWEAR
- Brand name suffix
- UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| OCTINOXATE | 75 mg/mL |
| OCTISALATE | 35 mg/mL |
| TITANIUM DIOXIDE | 17 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
| 15FIX9V2JP | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 07701e11-8a7e-44c5-b46e-5b48264eacad | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2022-08-04 | REPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY |
| 2022-07-29 | REPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY |
| 2020-12-03 | REPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY |
| 2020-01-31 | REPAIRWEAR UPLIFTING FIRMING CREAM BROAD SPECTRUM SPF 15 DRY |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49527-017-01 | REPAIRWEARUPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY | 50 mL in 1 JAR | CREAM | 50 | 10 | |
| 49527-017-01 | REPAIRWEARUPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY | 1 in 1 CARTON | CREAM | 1 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49527-017 | REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY (OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20250416_07701e11-8a7e-44c5-b46e-5b48264eacad.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 |
|---|---|---|---|---|---|---|
| Bath and Body Works SPF At The Beach | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 1c315bdb-dc33-1737-e063-6294a90a31a4 | 2026-03-02 | Warnings | M020 |
| Bath and Body Works SPF Tahiti Isle | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Bath & Body Works, Inc. | 38d02c8d-cdc8-b8d6-e063-6294a90ad9e4 | 2026-03-02 | Warnings | M020 |
| Sport | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATE | Old East Main Co. | a460e512-f268-4941-beb6-29df10fdbb3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Tanning Sunscreen SPF 15 | AVOBENZONE HOMOSALATE OCTISALATE | Old East Main Co. | 42258ebe-e3cc-4d70-e063-6294a90a9651 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENE | Old East Main Co. | db876d34-1af9-4e0a-9e9a-32a8b00e9405 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Sunscreen | AVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENE | Old East Main Co. | 2ea288fe-815d-4568-9592-55ea428448fa | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | cea1c223-c9d4-42ac-8c5b-c0ca647d57a1 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Old East Main Co. | 00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 8f4a6a31-2fae-42fe-924f-10237c59e791 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ef48288b-533f-4924-ba12-fc8cb83643d4 | 2026-03-02 | Warnings | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | e6976bf4-ad77-4953-858f-4a0ec7f4300c | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | b3d2da09-d9c9-4c27-82fe-a434ece2f099 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ba9331ef-3744-4072-80a2-af95c6f7ee05 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 1a53d8d5-e650-4825-8a3b-7cf42c36e3e5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | 086dfda5-9fe7-46b4-9964-4977b86cfdd5 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Avobenzone, Homosalate, Octisalate | AVOBENZONE, HOMOSALATE, OCTISALATE | Old East Main Co. | ce9a2139-c5c2-43e2-bd51-1f14ace594d9 | 2026-03-02 | Warnings, Adverse reactions | M020 |
| Bask SPF 40 Broad Spectrum | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Surfside Skincare, Inc. dba Bask Suncare | 49a30877-e39f-46a3-e063-6394a90a8dd2 | 2026-03-02 | Warnings | M020 |
| Sunscreen SPF30 | AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5% | Worthy Promotional Products | f6014a97-12d3-4f42-86de-866a206c6c06 | 2026-03-02 | Warnings | M020 |
| 2000DL-CL30V | SPF30 BS VANILLA | Epic Laboratories, LLC | 02488aad-28be-4ffb-e063-6294a90ad01e | 2026-03-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49527-017-01 | 49527001701 | 1 JAR in 1 CARTON (49527-017-01) / 50 mL in 1 JAR | 1 jar | 2020-11-24 | 0000-00-00 | No | No | Current |