FDA.reportPublic FDA data

CLINIQUE CX

Manufacturer
CLINIQUE LABORATORIES INC | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd. | Aveda Corporation
Effective date
2010-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:26:16

Label at a glance#

ProductCLINIQUE CX PROTECTIVE BASE SPF 40
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE, TITANIUM DIOXIDE
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

active ingredients: octinoxate 7.50% [] octisalate 5.00% [] zinc oxide 4.60% [] titanium dioxide 1.70%

INACTIVE INGREDIENT SECTION

inactive ingredients: water (aqua purificata) purified [] butylene glycol [] c12-15 alkyl benzoate [] dimethicone [] jojoba esters [] caprylic/capric triglyceride [] cetearyl alcohol [] silica [] micrococcus lysate [] gentiana lutea (gentian) root extract [] coffea robusta seed extract [] helianthus annuus (sunflower) seedcake [] cucumis sativus (cucumber) fruit extract [] sea whip extract [] cholesterol [] astrocaryum murumuru butter [] hordeum vulgare (barley) extract [] linoleic acid [] butyrospermum parkii (shea butter) [] caffeine [] salvia sclarea (clary) extract [] sodium rna [] sodium hyaluronate [] phytosphingosine [] tocopheryl acetate [] sodium dna [] cetearyl glucoside [] zeolite [] stearic acid [] chamomilla recutita (matricaria) [] sucrose [] peg-100 stearate [] lecithin [] trehalose [] hydrogenated lecithin [] hexylene glycol [] propylene glycol dicaprate [] tricaprylin [] polyhydroxystearic acid [] polyethylene [] methyl gluceth-20 [] ethylhexyl stearate [] carbomer [] behenyl alcohol [] alumina [] ethylhexyl palmitate [] caprylyl glycol [] cetyl alcohol [] triethoxycaprylylsilane [] xanthan gum [] aluminum stearate [] disodium edta [] bht [] phenoxyethanol [] mica [] titanium dioxide (ci 77891) [] iron oxides (ci 77491, ci 77492, ci 77499)

WARNINGS SECTION

warning: keep out of eyes. stop use if irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of chidren

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panel:


CLINIQUE CX

PROTECTIVE BASE

SPF 40

  • daily protection for easily stressed skin
  • calms and comforts
CLINIQUE LABORATORIES

1.7 fl oz/50 ml


clinique laboratories, distr.
new york, ny
10022

clinique.com
folding carton
folding carton



FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-953-012020-01-31C16284748780-19d75b9d1-1b69-f424-e053-dadaa90a57ce75201871-e084-48e0-9e18-a0b2bf280626

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-953-01CLINIQUE CXPROTECTIVE BASE SPF 401 in 1 CARTONCREAM11
49527-953-02CLINIQUE CXPROTECTIVE BASE SPF 4050 mL in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-953CLINIQUE CX PROTECTIVE BASE SPF 40 (OCTINOXATE, OCTISALATE, ZINC OXIDE,TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC]1Legacy NDC, 2 package rows20101104_75201871-e084-48e0-9e18-a0b2bf280626.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
C12-15 ALKYL BENZOATEINACTIVE INGREDIENTA9EJ3J61HQ1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-95349527-953-02, 49527-953-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT

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 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 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
3db07dee-3ef4-417d-a4ac-1a18421ddcb475201871-e084-48e0-9e18-a0b2bf2806262010-11-03WarningsExact identifier
spl id: 3db07dee-3ef4-417d-a4ac-1a18421ddcb4
spl set id: 75201871-e084-48e0-9e18-a0b2bf280626

Reported adverse events (FAERS/openFDA)#

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