FDA.reportPublic FDA data

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage49527-083-0005c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage49527-083-0048b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage49527-083-0027f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage49527-083-008d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage49527-083-00d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage49527-083-0050b4072663b7…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
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE70 mg/mL
OCTINOXATE35 mg/mL
OCTISALATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb841fd7-0c78-01a1-e053-6394a90a4382Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-083-01SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-01SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3050 mL in 1 JARCREAM502
49527-083-02SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3075 mL in 1 JARCREAM752
49527-083-02SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-03SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-03SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3015 mL in 1 JARCREAM152
49527-083-04SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12
49527-083-04SMART CLINICAL REPAIR BROAD SPECTRUM SPF 305 mL in 1 JARCREAM52
49527-083-05SMART CLINICAL REPAIR BROAD SPECTRUM SPF 3030 mL in 1 JARCREAM302
49527-083-05SMART CLINICAL REPAIR BROAD SPECTRUM SPF 301 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-083SMART CLINICAL REPAIR BROAD SPECTRUM SPF 30 (AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]2Current NDC, 10 package rows20231116_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 86 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ST MORIZ SUNCARE BODY SUNSCREEN SPF30SUNCARE BODY SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.48026f09-6d15-8fa6-e063-6294a90a17cb2026-01-09WarningsExact identifier
application number: M020
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
application number: M020
FACE SPF 47 SETTINGFACE SPF 47 SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47db9a54-c02f-d2ea-e063-6394a90ab9732026-01-08WarningsExact identifier
application number: M020
BADABOOM SUNSCREENSUNSCREENAopline Biotechnology (Guangzhou) Co., Ltd.47dbf363-2892-4530-e063-6294a90abe1f2026-01-08WarningsExact identifier
application number: M020
ROE WELLNESS SPF 50 MINERALSPF 50 MINERAL POWDERAopline Biotechnology (Guangzhou) Co., Ltd.47dc8155-4abb-4bb7-e063-6294a90af1ad2026-01-08WarningsExact identifier
application number: M020
ALOHA MINERAL BLOCK-BRUSH ON MINERALSUNSCREEN SPF50Aopline Biotechnology (Guangzhou) Co., Ltd.47dd07aa-71b4-5d54-e063-6394a90a41272026-01-08WarningsExact identifier
application number: M020
SUNSCREEN SETTING SPRITZ, SPF 45SUNSCREEN SETTING SPRAYAopline Biotechnology (Guangzhou) Co., Ltd.47ddf752-cae2-313f-e063-6294a90a7e3a2026-01-08WarningsExact identifier
application number: M020
St Moriz suncare face sunscreen spf50OCTOCRYLENE, OCTISALATE , AVOBENZONE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df072e-151f-eb30-e063-6294a90a4eeb2026-01-08WarningsExact identifier
application number: M020
SUNSCREEN GLOWINGAVOBENZONE ,OCTISALATE ,OCTOCRYLENE , HOMOSALATEAopline Biotechnology (Guangzhou) Co., Ltd.47df0de5-012a-c896-e063-6394a90a9cef2026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35f6-63d2-3d26-e053-2991aa0a5b442026-01-08WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC616d35a1-a139-1974-e053-2a91aa0a20b62026-01-08WarningsExact identifier
application number: M020
PIPA SKIN CARE SUN-SATIONAL Mineral SunscreenSPF 30EVI LABS258b7b7c-a3f2-172c-e063-6394a90aec6a2026-01-08WarningsExact identifier
application number: M020
DMK Ultrascreen Mineral SunscreenZINC OXIDEDanne Montague King3f022275-c1e5-2704-e063-6294a90a4a812026-01-08WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.0cc8221d-5ec5-4abf-a4f5-ab06e8dcea682026-01-08WarningsExact identifier
application number: M020
Rejuvaskin Mineral Facial Sunscreen SPF 32 SheerREJUVASKIN MINERAL FACIAL SUNSCREEN SPF 32 SHEERAtlantic Medical Products, LLC47e5198e-7bf6-72a8-e063-6294a90a7ec52026-01-08WarningsExact identifier
application number: M020
inde wild SUN DEFENSE SPF 50 SUNSCREEN GLOW DROPS BROAD SPECTRUMINDE WILD SUN DEFENSE GLOW DROPSINDE WILD PRIVATE LIMITED47e57407-2925-09ca-e063-6294a90a49ec2026-01-08WarningsExact identifier
application number: M020
NIDA Invisible Fit SunscreenSUNSCREENProso Corp47ed3b62-45ef-b67a-e063-6294a90a317b2026-01-08WarningsExact identifier
application number: M020
Organic Matters SPF 50 SunscreenZINC OXIDEVeganic SKN Limited12f37c8d-07f0-3e75-e063-6294a90a2cdf2026-01-08WarningsExact identifier
application number: M020
Ellegreen Sunscreen Broad Spectrum SPF50ZINC OXIDEVeganic SKN Limited161a7209-10d8-928c-e063-6394a90a41392026-01-08WarningsExact identifier
application number: M020
Live Sunny Eco-zinc hydrating mineral sunscreen for body and faceZINC OXIDEVeganic SKN Limited1a97169e-67be-3d25-e063-6294a90a3b882026-01-08WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49527-083-01495270083011 JAR in 1 CARTON (49527-083-01) / 50 mL in 1 JAR1 jar2023-05-12NoNoCurrent
49527-083-02495270083021 JAR in 1 CARTON (49527-083-02) / 75 mL in 1 JAR1 jar2023-05-12NoNoCurrent
49527-083-03495270083031 JAR in 1 CARTON (49527-083-03) / 15 mL in 1 JAR1 jar2023-05-12NoNoCurrent
49527-083-04495270083041 JAR in 1 CARTON (49527-083-04) / 5 mL in 1 JAR1 jar2023-05-12NoNoCurrent
49527-083-05495270083051 JAR in 1 CARTON (49527-083-05) / 30 mL in 1 JAR1 jar2023-05-12NoNoCurrent