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 142 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Sunscreen Dry Touch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 334ffc49-3196-0995-e063-6394a90ad559 2025-12-09 Exact identifier application number: M020 Foam Weightless Sunscreen Non-Tinted Drytouch NT TITANIUM DIOXIDE, ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 335ec22c-6a9a-c4d1-e063-6394a90ac0b0 2025-12-09 Exact identifier application number: M020 Mineral Sunscreen Moisturizing Non-Tinted ZINC OXIDE Cutis Wellness Dermatology And Dermatopathology PLLC 3360a208-5f17-a74b-e063-6294a90a13e1 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 323356ea-31a0-6ff0-e063-6294a90a135c 2025-12-09 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32330376-5db0-202b-e063-6294a90add15 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 32354468-94a2-604b-e063-6394a90adfb5 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 32346536-f542-ef0f-e063-6394a90a0464 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Untinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 3234b498-5b56-55f4-e063-6294a90a9b87 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Tinted ZINC OXIDE Lily Lee, MD 3235a696-92aa-788c-e063-6394a90a0149 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Mineral Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE Lily Lee, MD 32351db0-884c-8fa0-e063-6294a90acba2 2025-12-09 Exact identifier application number: M020 Sunscreen Plus Untinted ZINC OXIDE Lily Lee, MD 3235786d-7ba9-c9ab-e063-6294a90a7f2e 2025-12-09 Exact identifier application number: M020 Tinted Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 31416d04-2d6f-7cf9-e063-6294a90a9806 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen Non-Tinted ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143968a-096e-b9ac-e063-6294a90ada0d 2025-12-09 Warnings Exact identifier application number: M020 Daily Mineral Sunscreen 20% Zinc Oxide ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 314299b1-a78b-c1bd-e063-6294a90ab43b 2025-12-09 Warnings Exact identifier application number: M020 Sheer Satin Mineral Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3143d8b0-4af8-f52d-e063-6294a90a926b 2025-12-09 Warnings Exact identifier application number: M020 Matte Invisible Mineral Sunscreen ZINC OXIDE INTEGRATIVE AESTHETICS BOSTON, LLC 3142ed0f-f379-f240-e063-6294a90a5303 2025-12-09 Warnings Exact identifier application number: M020 Sheer Non-Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33d83cfb-045d-141c-e063-6394a90a2e04 2025-12-09 Exact identifier application number: M020 First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 45875865-5e9c-d652-e063-6394a90ad5fa 2025-12-09 Warnings Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Maloney Plastic Surgery Skin Care, PLLC 316b7584-c782-fe9e-e063-6394a90a76fe 2025-12-09 Exact identifier application number: M020 Transparent Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE Face Collection, L.L.C. 33dbfd9b-b90f-bb32-e063-6294a90af7dc 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