CLINIQUE

Manufacturer
CLINIQUE LABORATORIES INC. | ELGC K.K. | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | Estee Lauder Inc. | ESTEE LAUDER COSMETICS DISTRIBUTION CENTER | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTEC KEYSTONE | NORTHTEC BRISTOL | NORTHTEC KEYSTONE | WHITMAN LABORATORIES, LTD. | Aveda Corporation | Pennsylvania Logistics Center
Effective date
2012-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:41

Label at a glance#

ProductCLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION
Active ingredienthomosalate, octisalate, avobenzone, octocrylene
Label structure6 sections

Label contents#

Full prescribing information#

TO USE

INDICATIONS & USAGE SECTION

Apply liberally before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply frequently, and after towel drying, swimming or perspiring.

WARNING

WARNINGS SECTION

For external use only. Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help right away.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

HOMOSALATE 10.0% • OCTISALATE 5.0% • AVOBENZONE 3.0% • OCTOCRYLENE 2.7%

INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER • BUTYLENE GLYCOL • ISONONYL ISONONANDATE • BUTYLOCTYL SALICYLATE • TRIACONTANYL PVP • POLYESTER-8 • SILICA • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • STEARYL DIMETHICONE • CAFFEINE • PLANKTON EXTRACT • SUCROSE • HYDROGENATED LECITHIN • POTASSIUM CETYL PHOSPHATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • PEG-100 STEARATE • CETYL ALCOHOL • POLYETHYLENE • ACRYLIC ACID/VP CROSSPOLYMER • VP/EICOSENE COPOLYMER • TOCOPHERYL ACETATE • TROMETHAMINE • SODIUM RNA • ALOE BARBADENSIS POWDER • PHOSPHOLIPIDS • LECITHIN • MAGNESIUM ASCORBYL PHOSPHATE • SODIUM HYALURONATE • HYDROXYPROPYL METHYLCELLULOSE • C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE • HYDROXYETHYLCELLULOSE • ASCORBYL TOCOPHERYL MALEATE • MALTODEXTRIN • CAPRYLYL GLYCOL • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • FERULIC ACID • DISODIUM EDTA • PHENOXYETHANOL • CHLORPHENESIN • MICA [ILN34995]

SPL UNCLASSIFIED SECTION

CLINIQUE LABORATORIES, DIST. NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 150 ml Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE

SPF
15
with SolarSmart

UVA UVB
advanced
protection

face/body
cream

5 FL. OZ.
150 ml e

Principal Display Panel - 150 ml Carton
Principal Display Panel - 150 ml Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
49527-735-012019-11-13C16284748780-197449f38-d05e-f6ea-e053-dbdaa90aa703CLINIQUE SPF 15 with SolarSmart

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-735-01CLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION150 mL in 1 BOTTLECREAM1501
49527-735-01CLINIQUE SPF 15 with SOLAR SMART ADVANCED PROTECTION1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-735CLINIQUE SPF 15 WITH SOLAR SMART ADVANCED PROTECTION (HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1Legacy NDC, 2 package rows20120807_340c82a5-bbf5-4528-bb25-51aa267f3b8a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOX1
homosalateACTIVE INGREDIENTV06SV4M95S1
octisalateACTIVE INGREDIENT4X49Y0596W1
octocryleneACTIVE INGREDIENT5A68WGF6WM1
avobenzoneACTIVE MOIETYG63QQF2NOX1
homosalateACTIVE MOIETYV06SV4M95S1
octisalateACTIVE MOIETY4X49Y0596W1
octocryleneACTIVE MOIETY5A68WGF6WM1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D31
caffeineINACTIVE INGREDIENT3G6A5W338E1
caprylyl glycolINACTIVE INGREDIENT00YIU5438U1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
chlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
ferulic acidINACTIVE INGREDIENTAVM951ZWST1
hexylene glycolINACTIVE INGREDIENTKEH0A3F75J1
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR71
hyaluronate sodiumINACTIVE INGREDIENTYSE9PPT4TH1
isononyl isononanoateINACTIVE INGREDIENTS4V5BS6GCX1
magnesium ascorbyl phosphateINACTIVE INGREDIENT0R822556M51
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
masoprocolINACTIVE INGREDIENT7BO8G1BYQU1
micaINACTIVE INGREDIENTV8A1AW08801
peg-100 stearateINACTIVE INGREDIENTYD01N1999R1
perilla frutescens leafINACTIVE INGREDIENTT4L5881Y681
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UT1
rosemaryINACTIVE INGREDIENTIJ67X351P91
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
sucroseINACTIVE INGREDIENTC151H8M5541
triacontanyl pvp (wp-660)INACTIVE INGREDIENTN0SS3Q238D1
tromethamineINACTIVE INGREDIENT023C2WHX2V1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-73549527-735-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 281 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
sucroseSUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VSOLUTION / URETHRAL0.12 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DFILM, SOLUBLE / ORAL19 mgExact identifier — unii candidate
15 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DPOWDER, FOR SUSPENSION / ORAL8000 mgExact identifier — unii candidate
15 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7CAPSULE, EXTENDED RELEASE / ORAL4.53 mgExact identifier — unii candidate
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, FILM COATED / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAVENOUS300 mgExact identifier — unii candidate
28 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VSUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
28 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS6.06 mgExact identifier — unii candidate
28 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucroseSUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
18 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7PASTE / DENTAL60 mgExact identifier — unii candidate
18 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRAVASCULAR225 mgExact identifier — unii candidate
28 equally ranked IID candidates
.alpha.-tocopherol acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION / INTRAMUSCULAR437 mgExact identifier — unii candidate
28 equally ranked IID candidates
sucroseSUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VGEL / TRANSDERMAL10 mgExact identifier — unii candidate
28 equally ranked IID candidates
hexylene glycolHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION, SOLUTION / INTRA-ARTERIAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VSOLUTION / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
28 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sucroseSUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
high density polyethyleneHIGH DENSITY POLYETHYLENEUG00KM4WR7TABLET / ORAL50 mgExact identifier — unii candidate
18 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VINJECTION / INTRA-ARTERIAL562 mgExact identifier — unii candidate
28 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNOINTMENT / TOPICAL7 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
tromethamineTROMETHAMINE023C2WHX2VCAPSULE / ORAL30 mgExact identifier — unii candidate
28 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucroseSUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ccaf35c2-e800-4f09-9881-55decb422123340c82a5-bbf5-4528-bb25-51aa267f3b8a2012-08-06WarningsExact identifier
spl id: ccaf35c2-e800-4f09-9881-55decb422123
spl set id: 340c82a5-bbf5-4528-bb25-51aa267f3b8a

Reported adverse events (FAERS/openFDA)#

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