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 52 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c500e58f-38b0-454e-8923-912844276b17 2026-03-20 Warnings Exact identifier application number: M020 Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZER TITANIUM DIOXIDE, ZINC OXIDE HEALTHY SKIN LAB LIMITED 4a1ec566-549f-45f2-a43d-dacfc7263361 2026-03-20 Warnings Exact identifier application number: M020 SOJO sunscreen ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d44efb6-abc5-c346-e063-6394a90a6023 2026-03-19 Warnings Exact identifier application number: M020 VRC Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d588fbe-e61a-2264-e063-6394a90aa060 2026-03-19 Warnings Exact identifier application number: M020 SOjO Lip balm SPF15 ZINC OXIDE Guangdong Aimu Biological Technology Co., Ltd 4d5ed865-fff2-ee44-e063-6294a90a67e2 2026-03-19 Warnings Exact identifier application number: M020 ActivDerm Radiant Shield Broad Spectrum SPF 40 ZINC OXIDE ACTIVDERM LLC 4d6307f1-bab6-5f44-e063-6294a90a8e36 2026-03-19 Warnings Exact identifier application number: M020 Mad Robbit DEFEND SPF30 SUNSCREEN MAD RABBIT TATTOO, INC. bf853d54-ecd9-40cc-9f10-cb546bfb8933 2026-03-19 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 SKNVcare, LLC 4d67dfb4-3607-2af6-e063-6294a90ae01a 2026-03-19 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d3a36b9-7d60-01ac-e063-6294a90af4fb 2026-03-18 Warnings Exact identifier application number: M020 GOODAL HEARTLEAF SOOTHING ZINC 100 MINERAL SUNSCREEN ZINC OXIDE CLIO COSMETICS Co., Ltd. c7b13245-a3e0-4d53-b7fe-9b2c9707ab9e 2026-03-18 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 BURNT MAPLE ZINC OXIDE COSMAX USA 4d318f51-1a43-44d5-e063-6394a90a4970 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 HAZY MAUVE ZINC OXIDE COSMAX USA 4d319110-e6a4-1ad3-e063-6394a90aa99c 2026-03-17 Warnings Exact identifier application number: M020 TIR TIR SUN BOUNCY GLOW LIP BALM SPF 30 SUNLIT CORAL ZINC OXIDE COSMAX USA 4d31b201-9d6a-730a-e063-6394a90a6700 2026-03-17 Warnings Exact identifier application number: M020 OSKIN New York Coffee BB Cream SPF 30 TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDE O'Skin Studio NY 29dae75a-4368-432a-9cf8-f0f021f09e29 2026-03-17 Warnings Exact identifier application number: M020 Premier Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Premier Plastic Surgery 4d39b64c-2e27-afed-e063-6394a90a3812 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d39ed7a-ca80-893c-e063-6294a90a03e7 2026-03-17 Warnings Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 4d3a0a92-b0de-a1ea-e063-6294a90a8508 2026-03-17 Warnings Exact identifier application number: M020 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Trader Joe's Company 4d3a36b9-7d63-01ac-e063-6294a90af4fb 2026-03-17 Warnings, Adverse reactions Exact identifier application number: M020 Redneck SPF 50 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Redneck Sunscreen LLC 4d3a460b-1b98-2906-e063-6294a90a3669 2026-03-17 Warnings Exact identifier application number: M020 Sunscreen BROAD SPECTRUM SPF 30 SKNVCARE, LLC 4d3ad051-3729-06fd-e063-6394a90ad0fe 2026-03-17 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