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., Len-Ron Manufacturing Division of Aramis Inc., Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., PALC, 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\eau butylene glycol dimethicone neopentyl glycol diheptanoate cetearyl alcohol silica peg-100 stearate lactobacillus ferment hordeum vulgare (barley) extract\extrait d'orge algae extract cucumis sativus (cucumber) fruit extract helianthus annuus (sunflower) seedcake cholesterol cetearyl glucoside propylene glycol dicaprate chamomilla recutita (matricaria) tridecyl trimellitate hydrogenated lecithin stearyl alcohol zeolite tridecyl stearate isododecane dipentaerythrityl hexacaprylate/hexacaprate pvp oleth-10 laureth-4 laureth-23 caprylyl glycol hexylene glycol polyethylene tromethamine carbomer sodium citrate disodium edta sodium benzoate potassium sorbate chlorphenesin phenoxyethanol yellow 5 (ci 19140) yellow 6 (ci 15985) red 33 (ci 17200) [iln29625]

Other information

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

PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

CLINIQUE
FOR MEN

broad
spectrum
SPF 21
moisturizer

3.4 FL.OZ.LIQ./100 ml e

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: 49527-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03015 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.0744 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0503 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0201 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butylene glycol (UNII: 3XUS85K0RA)
dimethicone (UNII: 92RU3N3Y1O)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
cetostearyl alcohol (UNII: 2DMT128M1S)
silicon dioxide (UNII: ETJ7Z6XBU4)
peg-100 stearate (UNII: YD01N1999R)
lactobacillus reuteri (UNII: 9913I24QEE)
barley (UNII: 5PWM7YLI7R)
cucumber (UNII: YY7C30VXJT)
helianthus annuus seedcake (UNII: 482WYF7XLC)
cholesterol (UNII: 97C5T2UQ7J)
cetearyl glucoside (UNII: 09FUA47KNA)
propylene glycol dicaprate (UNII: U783H9JHWY)
matricaria chamomilla (UNII: G0R4UBI2ZZ)
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)
polyoxyl-10 oleyl ether (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)
carboxypolymethylene (UNII: 0A5MM307FC)
sodium citrate, unspecified form (UNII: 1Q73Q2JULR)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
sodium benzoate (UNII: OJ245FE5EU)
potassium sorbate (UNII: 1VPU26JZZ4)
chlorphenesin (UNII: I670DAL4SZ)
phenoxyethanol (UNII: HIE492ZZ3T)
fd&c yellow no. 5 (UNII: I753WB2F1M)
fd&c yellow no. 6 (UNII: H77VEI93A8)
d&c red no. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-068-01	1 in 1 CARTON	01/01/2012
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 NOT FINAL	part352	01/01/2012

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-068) , REPACK(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-068) , REPACK(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-068) , REPACK(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-068)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-068)