CLINIQUE

Manufacturer
CLINIQUE LABORATORIES INC. | ELGC Kabushiki Kaisha | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | ARAMIS, 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
Effective date
2011-10-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:47

Label at a glance#

ProductCLINIQUE SPF 50 with SOLAR SMART ADVANCED PROTECTION
Active ingredientoxybenzone, octisalate, homosalate, 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

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

INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER • METHYL TRIMETHICONE • BUTYLENE GLYCOL • BUTYLOCTYL SALICYLATE • NEOPENTYL GLYCOL DIHEPTANOATE • BUTYROSPERMUM PARKII (SHEA BUTTER) • PEG-100 STEARATE • SILICA • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • DIMETHICOME • GLYCERYL STEARATE • LAURDIMONIUM HYDROXYPROPYL HYDROLYZED SOY PROTEIN • ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • CAFFEINE • POTASSIUM CETYL PHOSPHATE • SUCROSE • STYRENE/ACRYLATES COPOLYMER • C30-38 OLEFIN/ISOPROPYL MALEATE/MA COPOLYMER • CETYL ALCOHOL • VP/EICOSENE COPOLYMER • ETHYLHEXYLGLYCERIN • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • PEG-8 LAURATE • SODIUM RNA • LECITHIN • ARGINNE FERULATE • TOCOPHERYL ACETATE • CAPRYLYL GLYCOL • PROPYL GALLATE • ASCORBYL TOCOPHERYL MALEATE • STEARIC ACID • XANTHAN GUM • HEXYLENE GLYCOL • NORDIHYDROGUAIARETIC ACID • DISODIUM EDTA • PHENOXYETHANOL • MICA • SODIUM DEHYDROACETATE [ILN37121]

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 150 ml Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE

SPF
50
with
SolarSmart

UVA UVB
advanced
protection

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
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
49527-734-012020-01-31C16284748780-19d75b9cf-f284-f424-e053-dadaa90a57ceCLINIQUE SPF 50 with SolarSmart

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-734-01CLINIQUE SPF 50 with SOLAR SMART ADVANCED PROTECTION150 mL in 1 BOTTLECREAM1501
49527-734-01CLINIQUE SPF 50 with SOLAR SMART ADVANCED PROTECTION1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-734CLINIQUE (OXYBENZONE, OCTISALATE, HOMOSALATE, AVOBENZONE, AND OCTOCRYLENE) CREAM [CLINIQUE LABORATORIES INC.]1Legacy NDC, 2 package rows20111019_2692bb05-1c5f-4eb9-be05-eded2ea5c632.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
avobenzoneACTIVE INGREDIENTG63QQF2NOX1
homosalateACTIVE INGREDIENTV06SV4M95S1
octisalateACTIVE INGREDIENT4X49Y0596W1
octocryleneACTIVE INGREDIENT5A68WGF6WM1
oxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
avobenzoneACTIVE MOIETYG63QQF2NOX1
homosalateACTIVE MOIETYV06SV4M95S1
octisalateACTIVE MOIETY4X49Y0596W1
octocryleneACTIVE MOIETY5A68WGF6WM1
oxybenzoneACTIVE MOIETY95OOS7VE0Y1
alpha-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L01
butylene glycolINACTIVE INGREDIENT3XUS85K0RA1
butyloctyl salicylateINACTIVE INGREDIENT2EH13UN8D31
caffeineINACTIVE INGREDIENT3G6A5W338E1
caprylyl glycolINACTIVE INGREDIENT00YIU5438U1
cetyl alcoholINACTIVE INGREDIENT936JST6JCN1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
edetate disodiumINACTIVE INGREDIENT7FLD91C86K1
ethylhexylglycerinINACTIVE INGREDIENT147D247K3P1
ferulic acidINACTIVE INGREDIENTAVM951ZWST1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE41
hexylene glycolINACTIVE INGREDIENTKEH0A3F75J1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2D1
masoprocolINACTIVE INGREDIENT7BO8G1BYQU1
methyl trimethiconeINACTIVE INGREDIENTS73ZQI0GXM1
micaINACTIVE INGREDIENTV8A1AW08801
neopentyl glycol diheptanoateINACTIVE INGREDIENT5LKW3C543X1
peg-100 stearateINACTIVE INGREDIENTYD01N1999R1
peg-8 laurateINACTIVE INGREDIENT762O8IWA101
perilla frutescens leafINACTIVE INGREDIENTT4L5881Y681
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
potassium cetyl phosphateINACTIVE INGREDIENT03KCY6P7UT1
rosemaryINACTIVE INGREDIENTIJ67X351P91
shea butterINACTIVE INGREDIENTK49155WL9Y1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU41
sodium dehydroacetateINACTIVE INGREDIENT8W46YN971G1
stearic acidINACTIVE INGREDIENT4ELV7Z65AP1
sucroseINACTIVE INGREDIENTC151H8M5541
waterINACTIVE INGREDIENT059QF0KO0R1
xanthan gumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-73449527-734-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 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 6 · 309 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii candidate
49 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
hexylene glycolHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KTABLET, EFFERVESCENT / ORAL32 mgExact identifier — unii candidate
77 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEPOWDER, FOR SUSPENSION / ORAL600 mgExact identifier — unii candidate
29 equally ranked IID candidates
peg-100 stearatePEG-100 MONOSTEARATEYD01N1999RCREAM / VAGINAL100 mgExact identifier — unii candidate
3 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KDROPS / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
sucroseSUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
maltodextrinMALTODEXTRIN7CVR7L4A2DTABLET / ORAL320 mgExact identifier — unii candidate
15 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / SUBCUTANEOUS6 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 DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
phenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNTABLET, FILM COATED, EXTENDED RELEASE / ORAL59 mgExact identifier — unii candidate
20 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
peg-100 stearatePEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii candidate
3 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSOLUTION / TOPICALNAExact identifier — unii candidate
20 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEECREAM / TOPICAL46 mgExact identifier — unii candidate
29 equally ranked IID candidates
sucroseSUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
peg-8 lauratePEG-8 LAURATE762O8IWA10SUSPENSION / TOPICAL0.63 %w/vExact identifier — unii candidate
2 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4LIQUID / TOPICAL1 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
xanthan gumXANTHAN GUMTTV12P4NEESUSPENSION, EXTENDED RELEASE / ORAL186.8 mgExact identifier — unii candidate
29 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KPOWDER, FOR SUSPENSION / ORAL285 mgExact identifier — unii candidate
77 equally ranked IID candidates
silicon dioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4SUPPOSITORY / RECTAL35 mgExact identifier — unii candidate
21 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
sucroseSUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
edetate disodiumEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact 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
ea862b96-2ee9-4a7a-81d9-3b7d88ab25e92692bb05-1c5f-4eb9-be05-eded2ea5c6322011-10-14WarningsExact identifier
spl id: ea862b96-2ee9-4a7a-81d9-3b7d88ab25e9
spl set id: 2692bb05-1c5f-4eb9-be05-eded2ea5c632

Reported adverse events (FAERS/openFDA)#

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