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 173 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MOOYAM Dark Skin Sunscreen SUNSCREEN Guangdong Bisutang Biotechnology Co., LTD 4246e9f1-1c51-d888-e063-6394a90abda0 2025-10-29 Warnings Exact identifier application number: M020 Biossance Squalane and Zinc Sheer Mineral Sunscreen Broad Spectrum SPF 30 ZINC OXIDE THG Beauty USA LLC 1cd10158-c346-60c9-e063-6294a90a54bd 2025-10-29 Warnings Exact identifier application number: M020 non-tinted mineral sunscreen TITANIUM DIOXIDE, ZINC OXIDE Clove Hill LLC 311b270f-b9e2-2374-e063-6294a90af581 2025-10-29 Warnings Exact identifier application number: M020 Hello Bello Kids Mineral Sunscreen ZINC OXIDE TITANIUM OXIDE Hello Bello 3e7a3e8e-eacf-0a30-e063-6294a90ab7ec 2025-10-29 Warnings Exact identifier application number: M020 Perricone MD Neuropeptide Restorative Neck and Chest Therapy Broad Spectrum SPF 25 TITANIUM DIOXIDE THG Beauty USA LLC 23f4cf41-0eed-2df3-e063-6294a90ad402 2025-10-28 Warnings Exact identifier application number: M020 goPure Sunscreen ZINC OXIDE Natural Lifestyle Brands, LLC dba GoPure beauty a74ec20b-8436-4030-820c-01fd88134f40 2025-10-27 Warnings Exact identifier application number: M020 KidsBliss Baby and Kids Mineral Sunscreen SPF50 ZINC OXIDE VeganicSKN 2dfa236f-128b-17bb-e063-6294a90aa29c 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun Mineral Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd7477-445f-d1d5-e063-6394a90a4607 2025-10-24 Warnings Exact identifier application number: M020 Oze Sun reef safe Sunscreen SPF50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41dd936b-0ea6-03a2-e063-6394a90a4fba 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 6 months to 6 years ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de1cd7-fdfd-7f7a-e063-6394a90a9b5c 2025-10-24 Warnings Exact identifier application number: M020 Soodox Natural Mineral Sunscreen SPF50 - 7 years to adult ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 41de09dc-544f-9780-e063-6394a90acd27 2025-10-24 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 23670a30-6619-0651-e063-6394a90af978 2025-10-24 Warnings Exact identifier application number: M020 PERRICONE MD VITAMIN C ESTER PHOTO-BRIGHTENING MOISTURIZER BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 397b4338-fec8-5228-e063-6394a90ad97d 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD HIGH POTENCY CLASSICS Face Finishing and Firming Tinted Moisturizer Broad Spectrum SPF 30 TITANIUM DIOXIDE THG Beauty USA LLC 38c80373-1d5a-c7f4-e063-6294a90aa9c2 2025-10-23 Warnings Exact identifier application number: M020 Perricone MD Cold Plasma Plus Daily Defense Moisturizer Broad Spectrum SPF 35 ZINC OXIDE, TITANIUM DIOXIDE THG Beauty USA LLC 254b4692-a459-6119-e063-6394a90a0a60 2025-10-23 Warnings Exact identifier application number: M020 AVOBENZONE,OCTINOXATE,OCTISALATE,OCTOCRYLENE CHOP SAVER FRESH CITRUS SPF 15 LIP BALM Good for the Goose Products, LLC 2786cec8-0b8e-9c83-e063-6394a90ab338 2025-10-23 Warnings Exact identifier application number: M020 Calendula Essential Hydrating Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Naturopathica Holistic Health 41d75815-e281-bf88-e063-6294a90afeff 2025-10-23 Warnings Exact identifier application number: M020 Thrive Daily Sunscreen For Sensitive Skin SPF 30 ZINC OXIDE Thrive Natural Care, Inc 128e1a3a-df40-f51c-e063-6394a90a1902 2025-10-23 Warnings Exact identifier application number: M020 Thrive Bodyshield 50 SPF 50 ZINC OXIDE Thrive Natural Care, Inc 12d9e1d0-c59c-f770-e063-6294a90a8191 2025-10-23 Warnings Exact identifier application number: M020 Good Defense Daily Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE Offspring Beauty Co. 2a462e60-6353-f791-e063-6294a90a62e3 2025-10-23 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