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 |
|---|---|---|---|---|---|---|
| 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 | 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 |