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 157 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join KOVR Military grade sunscreen for Men ZINC OXIDE ACTIVE LIFE INC c9fbbc6e-6284-4308-89a3-98300c3a0320 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 50 ZINC OXIDE The Hain Celestial Group, Inc. 4484b16f-f29a-60cc-e063-6294a90a2b9d 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF50 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9c4b9-8e85-980c-e063-6394a90a9e7e 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sensitive Mineral SPF 30 ZINC OXIDE The Hain Celestial Group, Inc. 44867882-d9c1-7389-e063-6294a90a7f77 2025-11-26 Warnings Exact identifier application number: M020 Alba Botanica Sheer Mineral SPF30 ZINC OXIDE The Hain Celestial Group, Inc. 0cf9361f-f292-6429-e063-6294a90add0e 2025-11-26 Warnings Exact identifier application number: M020 ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 AVOBENZONE, OCTISALATE, OCTOCRYLENE ZO Skin Health, Inc. ec8386f2-9cb7-40f4-e053-2995a90ac2d8 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 330a9f2e-7ce1-f83f-e063-6394a90a184a 2025-11-26 Warnings Exact identifier application number: M020 WOODSLEEP Tallow Sunscreen TITANIUM DIOXIDE Shantou Woodsleep Biotechnology Co., Ltd. 33cdde09-e7ee-e003-e063-6394a90a8762 2025-11-26 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44718c3c-b081-bcfb-e063-6394a90a3786 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472cc1e-6b34-388b-e063-6394a90ac7b6 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4472ef69-8992-fcab-e063-6294a90a6b90 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 44732f89-8ac3-8c5d-e063-6394a90aba73 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 447347d6-b8a3-7338-e063-6294a90abbf9 2025-11-25 Warnings Exact identifier application number: M020 Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30 ZINC OXIDE The Procter & Gamble Manufacturing Company 4473c4cc-f8b5-4a92-e063-6394a90ae690 2025-11-25 Warnings Exact identifier application number: M020 salmon colored sunscreen SALMON COLORED SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 4477964b-28f3-a371-e063-6294a90a4230 2025-11-25 Warnings Exact identifier application number: M020 Safe Sea SPF 50 Mineral ZINC OXIDE Nidaria Technology Ltd. f6cf9454-552b-486e-a38b-ab3c183b24a1 2025-11-24 Warnings Exact identifier application number: M020 Safe Sea SPF 30 ZINC OXIDE Nidaria Technology Ltd. 91bf07ed-0be4-43c9-b5f3-4e8eb892bca5 2025-11-24 Warnings Exact identifier application number: M020 Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15 OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 5904baa8-3070-1d77-e053-2a91aa0a6852 2025-11-24 Warnings Exact identifier application number: M020 it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA, Inc. 86eea4df-4191-4e05-9f05-4a98ef8c2a4d 2025-11-24 Warnings Exact identifier application number: M020 Cetaphil Sun Tinted Face SPF 40 TITANIUM DIOXIDE, ZINC OXIDE Galderma Laboratories, L.P. 22413f93-7219-4726-b741-2392e576b34a 2025-11-24 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