SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
- Product NDC
- 49527-083
- 11-digit product format
- 495270083
- Labeler code
- 49527
- Product ID
- 49527-083_0a35474f-c644-433e-e063-6294a90a3a75
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- CLINIQUE LABORATORIES LLC
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-05-12
- Substance
- AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
- Active strength
- 30; 70; 35; 45 mg/mL; 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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 49527-083-00 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 49527-083-00 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 49527-083-00 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 49527-083-00 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 49527-083-00 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 49527-083-00 | 50b4072663b7… | eae3003ed65e… |
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
- SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| AVOBENZONE | 30 mg/mL |
| HOMOSALATE | 70 mg/mL |
| OCTINOXATE | 35 mg/mL |
| OCTISALATE | 45 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| G63QQF2NOX | Internal UNII lookup |
| V06SV4M95S | Internal UNII lookup |
| 4Y5P7MUD51 | Internal UNII lookup |
| 4X49Y0596W | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fb841fd7-0c78-01a1-e053-6394a90a4382 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7dea7767-9f52-b60a-5435-33cb9cc28bae | Product name | 4 | 20250124 |
| 6338270f-96cb-0ecb-6fbb-0a9bc78001f4 | Product name | 7 | 20250116 |
| 0ca83774-3f79-b837-5d6f-c210102f3bc8 | Product name | 6 | 20250114 |
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 2dc76302-91c0-4c35-ad78-99adfb049c4b | Product name | 1 | 20200603 |
| e6065d4b-5ae1-476f-a40e-f2851cbb5d2b | Product name | 2 | 20180221 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 332e86c3-7875-ca6e-f934-2206d2b31996 | Product name | 1 | 20140508 |
| 56625fcc-aa34-9d30-d0e9-1c1beb37ea21 | Product name | 1 | 20140508 |
| 7dfac40f-a405-cd2e-7c06-3059ec0e1092 | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
| d223c173-c39b-d764-47d4-d671d3088815 | Product name | 1 | 20140508 |
| e01133ad-4dcd-c7f3-454b-2ff569ee160a | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49527-083-01 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 49527-083-01 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 50 mL in 1 JAR | CREAM | 50 | 2 | |
| 49527-083-02 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 75 mL in 1 JAR | CREAM | 75 | 2 | |
| 49527-083-02 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 49527-083-03 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 49527-083-03 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 15 mL in 1 JAR | CREAM | 15 | 2 | |
| 49527-083-04 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 49527-083-04 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 5 mL in 1 JAR | CREAM | 5 | 2 | |
| 49527-083-05 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 30 mL in 1 JAR | CREAM | 30 | 2 | |
| 49527-083-05 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 | 1 in 1 CARTON | CREAM | 1 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49527-083 | SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC] | 2 | Current NDC, 10 package rows | 20231116_fb841fd7-0c78-01a1-e053-6394a90a4382.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 |
|---|---|---|---|---|---|---|
| PRO-TECT SUNSCREEN FOR PROFESSIONALS | MERADIMATE, OCTINOXATE, OCTISALATE, OXYBENZONE | Bio-Medical & Pharmaceutical Manufacturing Corporation | 374e172b-90e8-4fca-8934-dee3ed7b599d | 2025-12-03 | Warnings | M020 |
| LBEL SOLUTIONS PRO HIALURON BALM BALSAMO LABIAL HIDRATANTE 72H FPS 20 HYDRATING LIP BALM 72H SPF 20 BERRY UNIVERSEL | OCTINOXATE, ZINC OXIDE | BEL STAR S A | 25b6cb46-6516-376a-e063-6394a90a44f6 | 2025-12-03 | Warnings | M020 |
| LBEL LUMI AGE ANTI AGING NOURISHING FACIAL WITH SPF 30 | AVOBENZONE, OCTISALATE, OCTOCRYLENE | BEL STAR SA | 4510cd0d-40b8-f452-e063-6394a90a44e5 | 2025-12-03 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 45117885-c674-b58a-e063-6394a90af5f4 | 2025-12-03 | Warnings | M020 |
| CANNON BALM | OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE | DUKE CANNON SUPPLY CO. | f70a0173-c8ba-da7c-e053-6294a90a67db | 2025-12-03 | Warnings | M020 |
| CANNON BALM 140 | AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | DUKE CANNON SUPPLY CO. | f70c8632-ed11-0cc3-e053-6394a90a77db | 2025-12-03 | Warnings | M020 |
| Omega-Boost Sheer Mineral Sunscreen | MINERAL SUNSCREEN | Trilogy Natural Products Limited | 0405b7a6-6885-ed93-e063-6294a90a9386 | 2025-12-03 | Warnings | M020 |
| Poolside Hot Head SPF 30 hair scalp sunscreen mist | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517da75-c91a-1f93-e063-6394a90a65ac | 2025-12-03 | Warnings | M020 |
| Poolside Tropic Touch SPF 30 Sunscreen Body spray. | HOMOSALATE , OCTOCRYLENE , OCTISALATE , AVOBENZONE | Longway Technology(Guangzhou)Co.,Ltd. | 4517ef95-8ea1-3de6-e063-6394a90a2c79 | 2025-12-03 | Warnings | M020 |
| Poolside Orange Creme SPF 30 Sunscreen oil mist | HOMOSALATE 15%, OCTOCRYLENE 10%, OCTISALATE 5%, AVOBENZONE 3% | Longway Technology(Guangzhou)Co.,Ltd. | 4517fd05-ea60-0492-e063-6294a90a28e9 | 2025-12-03 | Warnings | M020 |
| e.l.f. All Set For Sun SPF 45 Sunscreen | AVOBENZONE, OCTISALATE, OCTOCRYLENE | e.l.f. Cosmetics, Inc. | 26f43446-e5ee-57a5-e063-6394a90a8661 | 2025-12-03 | Warnings | M020 |
| Banana Boat | AVOBENZONE, HOMOSALATE, OCTOCRYLENE | Edgewell Personal Care Brands LLC | 7678467a-9da3-1b51-e053-2991aa0a568f | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection SPF 70 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENE | CARDINAL HEALTH, INC. | b60cf360-7c8d-5da4-e053-2995a90a24c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b6107d22-a992-eaa1-e053-2995a90a29c2 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader General Protection Sunscreen SPF 50 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b623defb-4a9d-6fc5-e053-2995a90ae846 | 2025-12-02 | Warnings | M020 |
| Cardinal Health Leader Sport Sunscreen SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | b62329d7-29e9-d111-e053-2a95a90aab06 | 2025-12-02 | Warnings | M020 |
| Leader Ultra Sheer SPF 100 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE | CARDINAL HEALTH, INC. | b5a467e0-a6ab-4136-8101-f22cc319de58 | 2025-12-02 | Warnings | M020 |
| Leader General Protection SPF 30 Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | CARDINAL HEALTH, INC. | 9544b046-055e-5886-e053-2a95a90ad09e | 2025-12-02 | Warnings | M020 |
| BANANA BOAT | AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE | Edgewell Personal Care Brands LLC | 44fe0844-cb74-7a04-e063-6294a90aca15 | 2025-12-02 | Warnings | M020 |
| CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 | AVOBENZONE,HOMOSALATE,OCTISALATE, AND OCTOCRYLENE | CLINIQUE LABORATORIES LLC | 44fe7468-001c-f2ee-e063-6394a90ae3b4 | 2025-12-02 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 49527-083-01 | 49527008301 | 1 JAR in 1 CARTON (49527-083-01) / 50 mL in 1 JAR | 1 jar | 2023-05-12 | No | No | Current |
| 49527-083-02 | 49527008302 | 1 JAR in 1 CARTON (49527-083-02) / 75 mL in 1 JAR | 1 jar | 2023-05-12 | No | No | Current |
| 49527-083-03 | 49527008303 | 1 JAR in 1 CARTON (49527-083-03) / 15 mL in 1 JAR | 1 jar | 2023-05-12 | No | No | Current |
| 49527-083-04 | 49527008304 | 1 JAR in 1 CARTON (49527-083-04) / 5 mL in 1 JAR | 1 jar | 2023-05-12 | No | No | Current |
| 49527-083-05 | 49527008305 | 1 JAR in 1 CARTON (49527-083-05) / 30 mL in 1 JAR | 1 jar | 2023-05-12 | No | No | Current |