FDA.reportPublic FDA data

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER

Manufacturer
CLINIQUE LABORATORIES LLC | Estee Lauder Companies Inc. | The Estee Lauder Inc
Effective date
2023-10-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:57:06

Label at a glance#

ProductCLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE
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

Avobenzone 3.0%
Octinoxate 7.4%
Octisalate 5.0%
Oxybenzone 2.0%

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

water\aqua\eau•butylene glycol•dimethicone•neopentyl glycol diheptanoate•cetearyl alcohol•peg-100 stearate•silica•hordeum vulgare (barley) extract\extrait d'orge•algae extract•cucumis sativus (cucumber) fruit extract•helianthus annuus (sunflower) seedcake•cholesterol•cetearyl glucoside•propylene glycol dicaprate•tridecyl trimellitate•hydrogenated lecithin•stearyl alcohol•zeolite•lactobacillus ferment•cetrimonium chloride•tridecyl stearate•isododecane•dipentaerythrityl hexacaprylate/hexacaprate•pvp•oleth-10•laureth-4•laureth-23•caprylyl glycol•hexylene glycol•polyethylene•tromethamine•carbomer•sodium citrate•disodium edta•potassium sorbate•phenoxyethanol•yellow 5 (ci 19140)•yellow 6 (ci 15985)•red 33 (ci 17200) [iln43259]

Other information

STORAGE AND HANDLING SECTION

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

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CLINIQUE
FOR MEN

broad
spectrum
SPF 21
moisturizer

3.4 FL.OZ.LIQ./100 ml ℮

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label
PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49527-081-012022-08-05C16284748780-1e4f33bdf-9ef5-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER
49527-081-012022-07-29C16284748780-1e4f33bdf-9ef5-d8a0-e053-dadaa90a6e4eCLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-081-01CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER1 in 1 CARTONLOTION15
49527-081-01CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER100 mL in 1 TUBELOTION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-081CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [CLINIQUE LABORATORIES LLC]5Current NDC, Legacy NDC, 2 package rows20231021_2e9463df-1c71-465f-9820-6cedefe07ad7.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49527-08149527-081-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
D&C RED NO. 339DBA0SBB0LIACT
AGAR, UNSPECIFIED89T13OHQ2BIACT
ZEOLITE AY3NG9WF08WIACT
LIMOSILACTOBACILLUS REUTERI9913I24QEEIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
DIMETHICONE92RU3N3Y1OIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PEG-100 STEARATEYD01N1999RIACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
BARLEY5PWM7YLI7RIACT
CUCUMBERYY7C30VXJTIACT
HELIANTHUS ANNUUS SEEDCAKE482WYF7XLCIACT
CHOLESTEROL97C5T2UQ7JIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
PROPYLENE GLYCOL DICAPRATEU783H9JHWYIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TRIDECYL STEARATEA8OE252M6LIACT
ISODODECANEA8289P68Y2IACT
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE554N82UWVWIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
OLETH-10JD797EF70JIACT
LAURETH-46HQ855798JIACT
LAURETH-23N72LMW566GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TROMETHAMINE023C2WHX2VIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

Source Document#

Source XML

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
CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZERAVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONECLINIQUE LABORATORIES LLC2e9463df-1c71-465f-9820-6cedefe07ad72023-10-20WarningsExact identifier
ndc (package): 49527-081-01
ndc (product): 49527-081
ndc11 (package): 49527008101
spl id: 0828eba6-8d0e-9a5a-e063-6394a90a2fca
spl set id: 2e9463df-1c71-465f-9820-6cedefe07ad7

Reported adverse events (FAERS/openFDA)#

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