FDA.reportPublic FDA data

CLINIQUE

Manufacturer
CLINIQUE LABORATORIES INC. | ELGC K.K. | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | 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 | NIPPON SHIKIZAI
Effective date
2014-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:38:09

Label at a glance#

ProductCLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure9 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.5%
Titanium Dioxide 4.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.
    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age:
    ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

isotridecyl isononanoate • dimethicone • squalane • dextrin palmitate • dimethicone/vinyl dimethicone crosspolymer • vinyl dimethicone/methicone silsesquioxane crosspolymer • talc • phytosteryl/octyldodecyl lauroyl glutamate • sorbitan sesquiisostearate • alumina • glycerin • salicylic acid • silica dimethyl silylate • tocopherol • sodium hyaluronate • nylon-12 • methyl methacrylate crosspolymer • hdi/trimethylol hexyllactone crosspolymer • stearic acid • triethoxycaprylylsilane • silica • magnesium myristate • tin oxide • dehydroacetic acid • [+/- titanium dioxide (ci 77891) • mica • iron oxides (ci 77499) • iron oxides (ci 77491) • iron oxides (ci 77492)] [iln40504]

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 10 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

C

CLINIQUE

moisture surge

cc
cream compact

hydrating colour corrector
broad spectrum SPF 25

POIDS NET WT. .35 OZ./10 g e

Principal Display Panel - 10 g Tube Carton
Principal Display Panel - 10 g Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-040-012020-01-31C16284748780-19d75b9cf-f1dc-f424-e053-dadaa90a57ceMOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-040-01CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 251 in 1 CARTONCREAM11
49527-040-01CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 2510 g in 1 TUBECREAM101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-040CLINIQUE MOISTURE SURGE CC COMPACT HYDRATING COLOUR CORRECTOR BROAD SPECTRUM SPF 25 (OCTINOXATE AND TITANIUM DIOXIDE) CREAM [CLINIQUE LABORATORIES INC.]1Legacy NDC, 2 package rows20140115_0978e6ea-adb2-43f4-aae3-e1cb620e48e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G6751
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
ISOTRIDECYL ISONONANOATEINACTIVE INGREDIENTWEF51750MT1
MAGNESIUM MYRISTATEINACTIVE INGREDIENTZ1917F05781
MICAINACTIVE INGREDIENTV8A1AW08801
NYLON-12INACTIVE INGREDIENT446U8J075B1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZ1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SQUALANEINACTIVE INGREDIENTGW89575KF91
STANNIC OXIDEINACTIVE INGREDIENTKM7N50LOS61
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P81
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-04049527-040-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ISOTRIDECYL ISONONANOATEWEF51750MTIACT
DIMETHICONE92RU3N3Y1OIACT
SQUALANEGW89575KF9IACT
TALC7SEV7J4R1UIACT
ALUMINUM OXIDELMI26O6933IACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
TOCOPHEROLR0ZB2556P8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
NYLON-12446U8J075BIACT
STEARIC ACID4ELV7Z65APIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM MYRISTATEZ1917F0578IACT
STANNIC OXIDEKM7N50LOS6IACT
DEHYDROACETIC ACID2KAG279R6RIACT
MICAV8A1AW0880IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT

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 · 262 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUPPOSITORY / RECTAL14 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FILM COATED, EXTENDED RELEASE / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, FOR SUSPENSION / ORAL24 mgExact identifier — unii candidate
35 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RSHAMPOO / TOPICALNAExact identifier — unii candidate
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SUSPENSION / ORAL2553 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTCAPSULE / ORAL14 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE PARTICLES / ORAL170 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION / ORAL200 mgExact identifier — unii candidate
49 equally ranked IID candidates
TOCOPHEROLTOCOPHEROLR0ZB2556P8TABLET / ORAL0.08 mgExact identifier — unii candidate
5 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTGRANULE, FOR SUSPENSION / ORAL11 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UCAPSULE, COATED PELLETS / ORAL14 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL18 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCREAM / VAGINAL50 mgExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
TALCTALC7SEV7J4R1ULOZENGE / ORAL50 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii candidate
20 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675DROPS / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
ALUMINUM OXIDEALUMINUM OXIDELMI26O6933TABLET / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675CAPSULE, DELAYED RELEASE / ORAL14 mgExact identifier — unii candidate
21 equally ranked IID candidates
TALCTALC7SEV7J4R1UGUM, CHEWING / BUCCALNAExact identifier — unii candidate
35 equally ranked IID candidates
FERRIC OXIDE REDFERRIC OXIDE RED1K09F3G675TABLET / ORAL8 mgExact identifier — unii candidate
21 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
20 equally ranked IID candidates
TALCTALC7SEV7J4R1USUSPENSION / ORAL234 mgExact identifier — unii candidate
35 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 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
89519e46-d9ca-47ba-b53f-6692d53d59ba0978e6ea-adb2-43f4-aae3-e1cb620e48e82014-01-06WarningsExact identifier
spl id: 89519e46-d9ca-47ba-b53f-6692d53d59ba
spl set id: 0978e6ea-adb2-43f4-aae3-e1cb620e48e8

Reported adverse events (FAERS/openFDA)#

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