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 206 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Orchidee Double Defense Skin Shield OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE Innovation Brands Inc. 74b3c33f-5db5-460d-97be-fa495b625249 2025-06-27 Warnings Exact identifier application number: M020 GHOSTED ZINC OXIDE Spooge a5b611c3-d4d3-461e-84d8-d04a29c74902 2025-06-26 Warnings Exact identifier application number: M020 Dew Me ZINC OXIDE Spooge 0c4b429b-7dd5-4929-95af-d02b6770f121 2025-06-26 Warnings Exact identifier application number: M020 Zinc FIVE-0 baby and kids mineral sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 38744f77-4845-eac4-e063-6294a90af648 2025-06-26 Warnings Exact identifier application number: M020 NYU Langone Health Lip Balm ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 38745b55-8da5-4627-e063-6394a90a24ca 2025-06-26 Warnings Exact identifier application number: M020 Active Skin Repair hydrating daily sunscreen ZINC OXIDE Innovacyn, Inc. 1eacdde1-f990-4962-92f1-3f41a8a3b193 2025-06-26 Warnings Exact identifier application number: M020 Cheeky ZINC OXIDE Spooge d377379a-a1be-4acf-9df5-2ff73fb5c83d 2025-06-26 Warnings Exact identifier application number: M020 TheOG ZINC OXIDE Spooge a2f781a8-eba8-48f5-8680-9235aae8a4ff 2025-06-26 Warnings Exact identifier application number: M020 Reef safe - Vitamin C sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0763-74e9-3a71-e063-6394a90a46fb 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - acne-prone sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f079c-5730-5111-e063-6394a90af2d8 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Face sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f0f79-016f-71a7-e063-6394a90a9286 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Baby zinc sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385f320c-9144-78b8-e063-6394a90a2e9d 2025-06-25 Warnings Exact identifier application number: M020 Reef safe - Zinc Sport sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 385ff227-1656-960a-e063-6294a90a913c 2025-06-25 Warnings Exact identifier application number: M020 Thermasun SPF50 Mineral Zinc facial sunscreen ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ecba0-2f7f-9178-e063-6394a90a44c4 2025-06-25 Warnings Exact identifier application number: M020 Reefsun sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 386ec055-4ae7-9d2d-e063-6394a90a83c0 2025-06-25 Warnings Exact identifier application number: M020 SR Active Sheer Zinc Face Stick SPF 50 20.6% ZINC OXIDE Skinresource.md, L.L.C. 29928ab0-4467-57cb-e063-6394a90ac4d3 2025-06-25 Warnings Exact identifier application number: M020 Sun Protection SPF 50 AVOBENZONE 2.9%, HOMOSALATE 4.0%, OCTISALATE 4.9%, OCTOCRYLENE 9.5% Skinresource.md, L.L.C. 2a0c3dd1-4bc0-6664-e063-6294a90af4b3 2025-06-25 Warnings Exact identifier application number: M020 MELAO WHITENING SUNSCREEN TITANIUM DIOXIDE Guangdong Aimu Biological Technology Co., Ltd 1aaf5942-ff13-ee07-e063-6394a90acd28 2025-06-25 Warnings Exact identifier application number: M020 Blooskim BEEF TALLOW SUNSCREEN NON-NANO ZINC OXIDE Guangzhou Haishi Biological Technology Co., Ltd. 384903fa-e739-08b8-e063-6394a90a7653 2025-06-24 Warnings Exact identifier application number: M020 Walgreens SPF 55 Sheer Face Mist Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WALGREEN COMPANY f05b45e2-2fcd-631e-e053-2995a90ad334 2025-06-24 Warnings 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