CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35- avobenzone,homosalate,octisalate, and octocrylene cream

CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 by

Drug Labeling and Warnings

CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Cosmetics Ltd, Estee Lauder Cosmetics Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

AVOBENZONE 3%
HOMOSALATE 7%
OCTISALATE 4.5%
OCTOCRYLENE 5%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or bronken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

Directions

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

WATER\AQUA\EAU,GLYCERIN,BUTYLENE GLYCOL,PHENYL TRIMETHICONE,BUTYLOCTYL SALICYLATE,PEG-100 STEARATE,SILICA,SILICA SILYLATE,HYDROGENATED LECITHIN,DEXTRIN PALMITATE,SODIUM HYALURONATE,CAFFEINE,CAPRYLYL GLYCOL,BIOSACCHARIDE GUM-1,CETEARYL ALCOHOL,POTASSIUM CETYL PHOSPHATE,HEXYLENE GLYCOL,TROMETHAMINE,TRIACONTANYL PVP,CARBOMER,STEARYL ALCOHOL,DEHYDROXANTHAN GUM,DISODIUM EDTA,PHENOXYETHANOL,POTASSIUM SORBATE <ILN54133>

Other information

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

PRINCIPAL DISPLAY PANEL

CLINIQUE
FOR MEN
daily hydrator
braod spectrum
SPF 35

2.5 FL.OZ.LIQ./75ml e

INGREDIENTS AND APPEARANCE

CLINIQUE FOR MEN DAILY HYDRATOR BROAD SPECTRUM SPF 35 
avobenzone,homosalate,octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAFFEINE (UNII: 3G6A5W338E)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
TROMETHAMINE (UNII: 023C2WHX2V)
PEG-100 STEARATE (UNII: YD01N1999R)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TRIACONTANYL PVP (UNII: N0SS3Q238D)
SILICA (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER (UNII: 0A5MM307FC)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-223-01	1 in 1 CARTON	12/01/2025
1		75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd		202952982	manufacture(49527-223)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Cosmetics Ltd.		204132062	pack(49527-223) , manufacture(49527-223) , label(49527-223)