CLINIQUE

Product NDC
49527-716
11-digit product format
495270716
Labeler code
49527
Product ID
49527-716_7a0ac6b2-61f0-47f2-bbeb-f6e50830d2b2
Type
HUMAN OTC DRUG
Nonproprietary name
octisalate, homosalate, oxybenzone, avobenzone, and octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES INC.
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-09-01
Marketing end
0000-00-00
Substance
OCTISALATE; HOMOSALATE; OXYBENZONE; AVOBENZONE; OCTOCRYLENE
Active strength
5 mL/100mL; mL/100mL; mL/100mL; mL/100mL; mL/100mL
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49527-716IInactivated by FDA2026-10-12
excluded packagepackage49527-71649527-716-01IInactivated by FDA2026-10-12

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49527-716-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49527-716-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49527-716-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49527-716-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49527-716-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49527-716-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49527-716-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49527-716-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49527-716-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49527-716-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49527-716-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49527-716-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage49527-716-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage49527-716-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage49527-716-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage49527-716-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage49527-716-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage49527-716-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage49527-716-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage49527-716-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage49527-716-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage49527-716-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-716-012020-01-31C16284748780-19d75b9d0-00e2-f424-e053-dadaa90a57ceCLINIQUE SPF 30 with SolarSmart

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-716-01CLINIQUE SPF 30 with SOLAR SMART50 mL in 1 BOTTLECREAM501
49527-716-01CLINIQUE SPF 30 with SOLAR SMART1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOXCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
homosalateACTIVE INGREDIENTV06SV4M95SCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
octisalateACTIVE INGREDIENT4X49Y0596WCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
octocryleneACTIVE INGREDIENT5A68WGF6WMCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
oxybenzoneACTIVE INGREDIENT95OOS7VE0YCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
avobenzoneACTIVE MOIETYG63QQF2NOXCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
homosalateACTIVE MOIETYV06SV4M95SCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
octisalateACTIVE MOIETY4X49Y0596WCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
octocryleneACTIVE MOIETY5A68WGF6WMCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
oxybenzoneACTIVE MOIETY95OOS7VE0YCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
butylene glycolINACTIVE INGREDIENT3XUS85K0RACLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D3CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
caffeineINACTIVE INGREDIENT3G6A5W338ECLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
caprylyl glycolINACTIVE INGREDIENT00YIU5438UCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3PCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
ferulic acidINACTIVE INGREDIENTAVM951ZWSTCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
hexylene glycolINACTIVE INGREDIENTKEH0A3F75JCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
masoprocolINACTIVE INGREDIENT7BO8G1BYQUCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
methyl trimethiconeINACTIVE INGREDIENTS73ZQI0GXMCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
micaINACTIVE INGREDIENTV8A1AW0880CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
neopentyl glycol diheptanoateINACTIVE INGREDIENT5LKW3C543XCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
peg-100 stearateINACTIVE INGREDIENTYD01N1999RCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
peg-8 laurateINACTIVE INGREDIENT762O8IWA10CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
perilla frutescens leafINACTIVE INGREDIENTT4L5881Y68CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UTCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
rosemaryINACTIVE INGREDIENTIJ67X351P9CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
shea butterINACTIVE INGREDIENTK49155WL9YCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
sodium dehydroacetateINACTIVE INGREDIENT8W46YN971GCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
sucroseINACTIVE INGREDIENTC151H8M554CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1
xanthan gumINACTIVE INGREDIENTTTV12P4NEECLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-716CLINIQUE (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1Legacy NDC, 2 package rows20111019_ea76f9b7-d0a4-4682-8ab9-17f5541afbf5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49527-716-014952707160150 mL in 1 BOTTLE50 mlHistorical