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 |
|---|---|---|---|---|---|---|
| Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit Of The Earth, Inc. | f540b0f6-3e6c-43a7-e053-2a95a90aba74 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 30 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f4481bf3-6dc7-5641-e053-2a95a90ad938 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City | LIP BALM SPF 30 SUNSCREEN STICK | Fruit of the Earth, Inc. | 3ec16996-ae86-4f5b-b1fd-c7b509cc5d50 | 2024-10-18 | Warnings | M020 |
| Cabana Beach Club with Mentha and Essential Oils SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | f452df0c-ea8d-e25c-e053-2995a90a1143 | 2024-10-18 | Warnings | M020 |
| FRUIT OF THE EARTH 100 DRY TOUCH BROAD SPECTRUM SPF 100 FACE SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | FRUIT OF THE EARTH, INC. | fa18f1a9-7a6a-856e-e053-6294a90aeafa | 2024-10-18 | Warnings | M020 |
| Cabana Beach Club with Blood Orange and Essential Oils SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit of the Earth, Inc. | f452f94a-d2f1-60ec-e053-2995a90a8827 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 50 Sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fruit Of The Earth, Inc. | f45d25d2-9305-5858-e053-2a95a90a7f7b | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth Sun Town City Mineral SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Fruit Of The Earth, Inc. | f53fff7a-ef8b-19c4-e053-2a95a90a4a2a | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Sport Sunscreen Continuous SPF 70 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | Fruit Of The Earth, Inc. | fd68012d-814b-ac07-e053-6394a90afc68 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Sport Sunscreen Ultra SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | FRUIT OF THE EARTH, INC. | fd687b34-e4c6-0458-e053-6394a90ac064 | 2024-10-18 | Warnings | M020 |
| Fruit of the Earth LUV THAT SUN Kids Sunscreen Ultra SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | FRUIT OF THE EARTH, INC. | fd786a06-88b7-fa35-e053-6394a90a84a5 | 2024-10-18 | Warnings | M020 |
| Chemical Sunscreen SPF50 with Antipollution | HOMOSALATE, OCTOCRYLENE, AVOBENZONE, OCTISALATE SUNSCREEN | Swiss-American CDMO, LLC | 59efb7dd-83f9-4222-9b7e-ea17ac4ece00 | 2024-10-18 | Warnings | M020 |
| CVS Health SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS Pharmacy | f0d6ac48-3d57-0f5c-e053-2a95a90a87cf | 2024-10-17 | Warnings | M020 |
| CVS HEALTH SPORT SPF 50 CLEAR SUNSCREEN | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f13f7361-56b3-7ea8-e053-2995a90a7641 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 50 Ultra Protection | AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENE | CVS PHARMACY | f11650bb-90a0-78a1-e053-2995a90a8e4c | 2024-10-17 | Warnings | M020 |
| CVS Health Sport SPF 70 Clear | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CVS Pharmacy | f31dd448-dc79-21f1-e053-2a95a90a7bb6 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Breakout Free Face | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f41478c8-76c0-727f-e053-2a95a90a8669 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Ultra Protection | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f12ba764-afea-3f81-e053-2a95a90a1291 | 2024-10-17 | Warnings | M020 |
| CVS Health SPF 30 Ultra Sheer | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f32ec4ef-352e-6a78-e053-2995a90af491 | 2024-10-17 | Warnings | M020 |
| CVS Health Sport SPF 50 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CVS PHARMACY | f40e5664-e3ca-badf-e053-2a95a90a913e | 2024-10-17 | 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 |