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 |
|---|---|---|---|---|---|---|
| Reef Babies SPF 50 Oxybenzone Free | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | d5ed3488-aa32-4a63-9996-12c6532c3a4d | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b559499c-6109-bf5e-e053-2995a90a4ac7 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5e24ca1-d041-355d-e053-2995a90a3d61 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | b5570cbd-89f5-65d5-e053-2995a90a54d1 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Azure Blue | ZINC OXIDE | Tropical Seas, Inc. | d23fe61a-3ffb-59d0-e053-2995a90a59e6 | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | b55a0bd0-2a32-2977-e053-2a95a90aa142 | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 30 | OCTOCRYLENE, OCTISALATE, AVOBENZONE | Tropical Seas, Inc. | 06d43525-86d8-f2d9-e063-6394a90afc81 | 2025-11-04 | Warnings | M020 |
| Land Shark Zinky SPF 36 Pacific Purple | ZINC OXIDE | Tropical Seas, Inc. | d240fe7c-9d16-78c9-e053-2a95a90a763c | 2025-11-04 | Warnings | M020 |
| Expedition BackCountry SPF 50 | OCTOCRYLENE, OCTISALATE, AND AVOBENZONE | Tropical Seas, Inc. | 06c1ac52-474c-db5c-e063-6294a90afb5f | 2025-11-04 | Warnings | M020 |
| Land Shark SPF 30 Tinted Zinc | ZINC OXIDE AND TITANIUM DIOXIDE | Tropical Seas, Inc. | d1287899-f178-6124-e053-2a95a90a95a5 | 2025-11-04 | Warnings | M020 |
| Naked Sundays BeautyScreen Peptide Foundation Tint | ZINC OXIDE | Naked Sundays | 1a623dfc-a8fc-858b-e063-6294a90a9c11 | 2025-11-04 | Warnings | M020 |
| Odacite Mineral Drops Sheer Sunscreen | ZINC OXIDE | Odacite | 303f3af6-631a-57a8-e063-6294a90addda | 2025-11-04 | Warnings | M020 |
| Medline | ZINC OXIDE | Medline Industries, LP | cadba3bc-4a06-872a-e053-2995a90ab447 | 2025-11-04 | Warnings | M020 |
| Perricone MD Hypoallergenic CBD Sensitive Skin Therapy Ultra-Lightweight Calming SPF 35 Veil | ZINC OXIDE | THG Beauty USA LLC | 2392c772-c251-1597-e063-6394a90a52f2 | 2025-11-03 | Warnings | M020 |
| Hawaiian Tropic everyday Active Sport Sunscreen SPF50 | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care LLC | dc7d0757-c8a2-7fdb-e053-2a95a90a5282 | 2025-11-03 | Warnings | M020 |
| MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant (80min) Mineral Sunscreen LIGHT | TITANIUM DIOXIDE AND ZINC OXIDE | MDSolarSciences | a7f906f6-3041-4c24-955d-90cdd402dd02 | 2025-11-03 | Warnings | M020 |
| Biopo Facial Mineral Sunscreen-Non Tinted SPF 40 | BIOPO FACIAL MINERAL SUNSCREEN-NON TINTED SPF 40 | Guangzhou Ariel Biotech Co., Ltd. | 42bc865f-29bd-da90-e063-6294a90aa16d | 2025-11-03 | Warnings | M020 |
| Biopo Facial Mineral Sunscreen- Tinted SPF 40 | BIOPO FACIAL MINERAL SUNSCREEN- TINTED SPF 40 | Guangzhou Ariel Biotech Co., Ltd. | 42bd8bce-2959-266a-e063-6394a90a9a41 | 2025-11-03 | Warnings | M020 |
| GoodSense SPF 30 Sunscreen | AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5%, OCTOCRYLENE 10% | Geiss, Destin, & Dunn, Inc. | c23c754a-9441-0a05-e053-2995a90afc55 | 2025-11-02 | Warnings | M020 |
| SPF 30 Sport Sunscreen GoodSense | AVOBENZONE 3%, HOMOSALATE 15%, OCTISALATE 5%, OCTOCRYLENE 8% | Geiss, Destin, & Dunn, Inc | a22c6359-435d-626b-e053-2a95a90ae0c6 | 2025-11-02 | 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 |