CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER- avobenzone, octinoxate, octisalate, and oxybenzone lotion

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER by

Drug Labeling and Warnings

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES LLC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When 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 product is 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\eaubutylene glycoldimethiconeneopentyl glycol diheptanoatecetearyl alcoholpeg-100 stearatesilicahordeum vulgare (barley) extract\extrait d'orgealgae extractcucumis sativus (cucumber) fruit extracthelianthus annuus (sunflower) seedcakecholesterolcetearyl glucosidepropylene glycol dicapratetridecyl trimellitatehydrogenated lecithinstearyl alcoholzeolitelactobacillus fermentcetrimonium chloridetridecyl stearateisododecanedipentaerythrityl hexacaprylate/hexacapratepvpoleth-10laureth-4laureth-23caprylyl glycolhexylene glycolpolyethylenetromethaminecarbomersodium citratedisodium edtapotassium sorbatephenoxyethanolyellow 5 (ci 19140)yellow 6 (ci 15985)red 33 (ci 17200) [iln43259]

Other information

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

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

CLINIQUE
FOR MEN

broad
spectrum
SPF 21
moisturizer

3.4 FL.OZ.LIQ./100 ml ℮

INGREDIENTS AND APPEARANCE

CLINIQUE FOR MEN BROAD SPECTRUM SPF 21 MOISTURIZER 
avobenzone, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-081
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	74 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)
ZEOLITE A (UNII: Y3NG9WF08W)
LIMOSILACTOBACILLUS REUTERI (UNII: 9913I24QEE)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
BARLEY (UNII: 5PWM7YLI7R)
CUCUMBER (UNII: YY7C30VXJT)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
PROPYLENE GLYCOL DICAPRATE (UNII: U783H9JHWY)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TRIDECYL STEARATE (UNII: A8OE252M6L)
ISODODECANE (UNII: A8289P68Y2)
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
OLETH-10 (UNII: JD797EF70J)
LAURETH-4 (UNII: 6HQ855798J)
LAURETH-23 (UNII: N72LMW566G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
TROMETHAMINE (UNII: 023C2WHX2V)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-081-01	1 in 1 CARTON	07/21/2021
1		100 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	07/21/2021

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
The Estee Lauder Inc		802599436	manufacture(49527-081) , pack(49527-081) , label(49527-081)