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 |
|---|---|---|---|---|---|---|
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357eee3c-1c21-5efb-e063-6294a90a4bb7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357e75ec-473e-df76-e063-6294a90a70c7 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f2f62-904a-2234-e063-6394a90aee72 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357f915a-bd77-350b-e063-6294a90ad27f | 2025-12-15 | M020 | |
| Complexion Correction Primer Sunscreen clear | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 357ff025-84ad-6d77-e063-6394a90aad95 | 2025-12-15 | M020 | |
| Complexion Correction Tinted Primer Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 358021a2-235b-825b-e063-6394a90a76f5 | 2025-12-15 | M020 | |
| Superscreen Daytime Mineral Sunscreen | ZINC OXIDE | MCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY | 35805e66-18e6-0e45-e063-6294a90afe58 | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 35474ac4-8a9d-6a84-e063-6394a90a9bad | 2025-12-15 | M020 | |
| Ultra Zinc Physical Defense | ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 357e315e-8802-ad73-e063-6394a90a2495 | 2025-12-15 | M020 | |
| Tinted Physical Defense | TITANIUM DIOXIDE, ZINC OXIDE | ATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER | 35477ed2-0875-58d5-e063-6294a90a3d5d | 2025-12-15 | M020 | |
| Anti Aging Daily Protection | ZINC OXIDE | LEVERRIER, KAMILA | 35465f21-8bcd-6e44-e063-6294a90a8e5f | 2025-12-15 | M020 | |
| Anti Aging Daily Protection | ZINC OXIDE | LEVERRIER, KAMILA | 3546d369-3435-b56a-e063-6294a90a0843 | 2025-12-15 | M020 | |
| Tinted Facial Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | HELTON SKIN & LASER INSTITUTE | 35a97770-2db9-99aa-e063-6294a90a459a | 2025-12-15 | M020 | |
| Tinted Replenishing Daily Protection | ZINC OXIDE | HELTON SKIN & LASER INSTITUTE | 35a9d07d-70e5-5eed-e063-6394a90aebaf | 2025-12-15 | M020 | |
| Non-Tinted Sports Stick | TITANIUM DIOXIDE, ZINC OXIDE | HELTON SKIN & LASER INSTITUTE | 35aa833a-19a1-99e9-e063-6394a90a840f | 2025-12-15 | M020 | |
| Tinted Facial Primer | TITANIUM DIOXIDE, ZINC OXIDE | BEE NATURALS | 36c3352e-fa51-19ad-e063-6394a90a591b | 2025-12-15 | M020 | |
| Luminous Tinted Moisturizing | ZINC OXIDE | SKIN BOSS L.L.C. | 35a8ae26-82eb-e4ca-e063-6394a90a0022 | 2025-12-15 | M020 | |
| Restore Tinted Moisturizing | ZINC OXIDE | SKIN BOSS L.L.C. | 35a8e92e-ced2-fdcd-e063-6294a90acedc | 2025-12-15 | M020 | |
| Velvet Tinted Moisturizing Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN BOSS L.L.C. | 35a871dc-a707-9963-e063-6294a90a4396 | 2025-12-15 | M020 | |
| Velvet NT Moisturizing Mineral Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | SKIN BOSS L.L.C. | 35a8508d-7069-c2d6-e063-6394a90a6219 | 2025-12-15 | 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 |