Home NDC 49527-083 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.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table 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 table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 70 mg/mL OCTINOXATE 35 mg/mL OCTISALATE 45 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table 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 table 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.
Matched openFDA labels page 141 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30dc6e23-ecca-ed0b-e063-6294a90a7951 2025-12-09 Warnings Exact identifier application number: M020 Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddc3d7-76df-3344-e063-6294a90a65ae 2025-12-09 Warnings Exact identifier application number: M020 Tinted Physical Block Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Tucson Acne Clinic 30ddf80c-8496-0f47-e063-6394a90afc18 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30dfa973-3217-1e18-e063-6294a90a8d41 2025-12-09 Warnings Exact identifier application number: M020 Lightly Tinted Mineral Block Sunscreen ZINC OXIDE Tucson Acne Clinic 30df0039-4dc1-7355-e063-6394a90ae800 2025-12-09 Warnings Exact identifier application number: M020 Advanced Lip Guard TITANIUM DIOXIDE, ZINC OXIDE ADVANCED DERMATOLOGY 32e66ff3-ae1a-4a2a-e063-6294a90a7963 2025-12-09 Exact identifier application number: M020 Skin Tone Defender 20% Zinc Oxide ZINC OXIDE Cali Skin Care LLC 308c711d-4c3e-1208-e063-6394a90a9cc2 2025-12-09 Warnings Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE ADVANCED DERMATOLOGY 32d781ca-7993-9875-e063-6294a90a5c26 2025-12-09 Exact identifier application number: M020 Advanced Light Perfecting Sunscreen ZINC OXIDE Advanced Dermatology 32e6c080-6ce3-8d99-e063-6294a90ac1bc 2025-12-09 Exact identifier application number: M020 StriVectin multi-action Super-C SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. b299df12-fbdd-437b-9bfa-4846e361725a 2025-12-09 Warnings Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f1e019-32c4-b733-e063-6394a90aca28 2025-12-09 Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f254cb-9de5-8f67-e063-6294a90a4e28 2025-12-09 Exact identifier application number: M020 StriVectin Advanced Retinol Daily Repair Moisturizer SPF30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE StriVectin Operating Company, Inc. cfbdbba8-a739-fd32-e053-2a95a90a6f31 2025-12-09 Warnings Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f20c14-070e-4f86-e063-6294a90ad4c2 2025-12-09 Exact identifier application number: M020 Hint of Tint ZINC OXIDE L.S. MOORE LLC 37f330a0-790a-1656-e063-6294a90a691c 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L.S. MOORE LLC 37f2e363-e85f-f601-e063-6294a90ab120 2025-12-09 Exact identifier application number: M020 Original Tint TITANIUM DIOXIDE, ZINC OXIDE L MOORE AESTHETICS 37f1ac8c-3bfb-10da-e063-6294a90a8ca8 2025-12-09 Exact identifier application number: M020 RoC Multi Correxion Revive and Glow Moisturizer SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE RoC Skincare 40d4cfeb-fb00-801e-e063-6394a90ada6b 2025-12-09 Warnings Exact identifier application number: M020 RADIANCE ZINC OXIDE L.S. MOORE LLC 37f2b104-0213-c88c-e063-6294a90a4247 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Lightly Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3350c673-2afd-a00a-e063-6294a90aa196 2025-12-09 Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table 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