FDA.reportPublic FDA data

CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY

Product NDC
49527-048
11-digit product format
495270048
Labeler code
49527
Product ID
49527-048_06fabe70-22e7-4814-e063-6394a90aead5
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE and OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-01
Substance
AVOBENZONE; OCTISALATE
Active strength
30; 50 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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct49527-048EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49527-04849527-048-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal 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
59eeb180-1ac6-44b3-9742-dc65287896bfAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product 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
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-048-012022-08-04C16284748780-1e4f33bdf-af26-d8a0-e053-dadaa90a6e4eCLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY
49527-048-012022-07-29C16284748780-1e4f33bdf-af26-d8a0-e053-dadaa90a6e4eCLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-048-01CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY1 in 1 CARTONCREAM17
49527-048-01CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY50 mL in 1 JARCREAM507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-048CLINIQUE SMART CUSTOM REPAIR MOISTURIZER BROAD SPECTRUM SPF 15 - VERY DRY/DRY (AVOBENZONE AND OCTISALATE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 2 package rows20231006_59eeb180-1ac6-44b3-9742-dc65287896bf.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 10 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARKZINC OXIDEYounique, LLC2173666b-6c72-449d-9f40-098ea174f3e12026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DARK DEEPZINC OXIDEYounique, LLC360ceb90-bec6-4fec-820a-a4d65008b8722026-07-23WarningsExact identifier
application number: M020
Younique Bare You BB Tinted Moisturizer Sunscreen Broad Spectrum SPF-30 DEEPZINC OXIDEYounique, LLC86c33a9e-9132-4377-8688-41e5844de62c2026-07-23WarningsExact identifier
application number: M020
MENOKIN 30 SECONDS GLOW AND CLEAR Gel SUNSCREEN MOISTUREAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEForest Avenue Co., Ltd.edbfcf21-96c6-4519-8b08-f9b5ada7d1d72026-07-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO NUDE SKIN BASE SERUM TINT COBERTURA ANTIMANCHAS FPS 15 ANTI DARK SPOT COVERAGE SERUM TINT FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.574c96e9-77a2-778f-e063-6394a90a0aae2026-07-23WarningsExact identifier
application number: M020
SKINSUIT LIP SPF 30ZINC OXIDESkin Authority LLCcb24d714-f6cd-4518-b146-627cfe6c2ccd2026-07-23WarningsExact identifier
application number: M020
SKINSUIT FACE SPF 50ZINC OXIDESkin Authority LLC389fc528-fda5-485a-ab37-f99fcf3ed0b32026-07-23WarningsExact identifier
application number: M020
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
application number: M020
Native Daily Face Mineral Sunscreen Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3519e5bc-8c07-0617-e063-6394a90a65ae2026-07-22WarningsExact identifier
application number: M020
Tula Skincare Radiant Skin Brightening Serum Skin Tint Broad Spectrum SPF 30 01 Very Light NeutralAVOBENZONE, AND OCTISALATEThe Procter & Gamble Manufacturing Company366144c4-ec80-e435-e063-6394a90aba542026-07-22WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
application number: M020
YSE Beauty Instant Glow TrioAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLC6742e089-565a-40bc-8ffa-ec06e79860282026-07-21WarningsExact identifier
application number: M020
YSE Beauty The Roadies Packable AM RoutineAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMSS Beauty LLCb0844331-d277-4cfb-957a-d8f9498836842026-07-21WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Day Cream SPF 30AVOBENZONE,OCTISALATE,OCTOCRYLENEBCM Cosmetique SAS328f96bc-fb68-33dc-e063-6294a90aecfa2026-07-21WarningsExact identifier
application number: M020
Sunscreen In the Raw SPF 50ZINC OXIDEBiomin LLC625523f0-366f-4148-b927-d726b7d1b9f42026-07-20WarningsExact identifier
application number: M020
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Broad Spectrum SPF 30 Coconut and PineappleZINC OXIDEThe Procter & Gamble Manufacturing Company3a87ddee-241d-f972-e063-6294a90a7e892026-07-20WarningsExact identifier
application number: M020
Native Mineral Suncare Daily Face Broad Spectrum SPF 30 UnscentedZINC OXIDEThe Procter & Gamble Manufacturing Company3a893b13-e7f5-c5b1-e063-6394a90a42532026-07-20WarningsExact identifier
application number: M020
Omnilux Mineral Facial SunscreenZINC OXIDEThe Lotus Global Group, Inc, dba GlobalMed Technologies5710c84b-9d6b-da4d-e063-6394a90a07372026-07-20WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-048-01495270048011 JAR in 1 CARTON (49527-048-01) / 50 mL in 1 JAR1 jar2015-12-010000-00-00NoNoCurrent