CLINIQUE SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15- avobenzone, octinoxate, and octisalate liquid

CLINIQUE by

Drug Labeling and Warnings

CLINIQUE by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ELGC K.K., Estee Lauder Pennsylvania Distribution Center 2 (PADC 2), ESTEE LAUDER COSMETICS DISTRIBUTION CENTER, 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 2.0%
Octinoxate 7.5%
Octisalate 5.0%

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 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 octyldodecyl neopentanoate hdi/trimethylol hexyllactone crosspolymer neopentyl glycol diheptanoate dimethicone silica steareth-21 butylene glycol pentylene glycol sigesbeckia orientalis (st. paul's wort) extract rosmarinus officinalis (rosemary) extract polyethylene coffea robusta seed extract polygonum cuspidatum root extract laurdimonium hydroxypropyl hydrolyzed soy protein saccharomyces lysate extract steareth-2 astrocaryum murumuru seed butter glycerin hydrogenated lecithin ethylhexyl stearate polysilicone-11 sucrose pvp/hexadecene copolymer acetyl glucosamine isohexadecane ethylhexylglycerin caffeine trimethylsiloxysilicate glyceryl polymethacrylate acrylates/c10-30 alkyl acrylate crosspolymer linoleic acid cholesterol polysorbate 80 palmitoyl oligopeptide ethylhexyl palmitate tromethamine tetrahexyldecyl ascorbate adenosine phosphate peg-8 lecithin sodium dna arginine ferulate acetyl hexapeptide-8 sodium hyaluronate phytantriol caprylyl glycol xanthan gum ascorbyl tocopheryl maleate phytosphingosine propylene glycol dicaprate acrylamide/sodium acryloyldimethyltaurate copolymer hexylene glycol nordihydroguaiaretic acid potassium sulfate sodium carbomer disodium edta sorbic acid chlorphenesin potassium sorbate phenoxyethanol [iln34202]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

CLINIQUE
skin supplies
for men

age defense hydrator
broad spectrum
SPF 15

hydrates, repairs, protects

ALL SKIN TYPES

1.7 FL.OZ.LIQ./50 ml e

INGREDIENTS AND APPEARANCE

CLINIQUE   SKIN SUPPLIES FOR MEN AGE DEFENSE HYDRATOR BROAD SPECTRUM SPF 15
avobenzone, octinoxate, and octisalate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-035
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0203 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.076 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0507 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
octyldodecyl neopentanoate (UNII: X8725R883T)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
dimethicone (UNII: 92RU3N3Y1O)
silicon dioxide (UNII: ETJ7Z6XBU4)
steareth-21 (UNII: 53J3F32P58)
butylene glycol (UNII: 3XUS85K0RA)
pentylene glycol (UNII: 50C1307PZG)
rosemary (UNII: IJ67X351P9)
high density polyethylene (UNII: UG00KM4WR7)
robusta coffee bean (UNII: V5032728L7)
polygonum cuspidatum root (UNII: 7TRV45YZF7)
saccharomyces lysate (UNII: R85W246Z1C)
steareth-2 (UNII: V56DFE46J5)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
glycerin (UNII: PDC6A3C0OX)
ethylhexyl stearate (UNII: EG3PA2K3K5)
sucrose (UNII: C151H8M554)
n-acetylglucosamine (UNII: V956696549)
isohexadecane (UNII: 918X1OUF1E)
ethylhexylglycerin (UNII: 147D247K3P)
caffeine (UNII: 3G6A5W338E)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
polysorbate 80 (UNII: 6OZP39ZG8H)
palmitoyl oligopeptide (UNII: HO4ZT5S86C)
ethylhexyl palmitate (UNII: 2865993309)
tromethamine (UNII: 023C2WHX2V)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
adenosine phosphate (UNII: 415SHH325A)
polyethylene glycol 400 (UNII: B697894SGQ)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
hyaluronate sodium (UNII: YSE9PPT4TH)
phytantriol (UNII: 8LVI07A72W)
caprylyl glycol (UNII: 00YIU5438U)
xanthan gum (UNII: TTV12P4NEE)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
phytosphingosine (UNII: GIN46U9Q2Q)
propylene glycol dicaprate (UNII: U783H9JHWY)
hexylene glycol (UNII: KEH0A3F75J)
masoprocol (UNII: 7BO8G1BYQU)
potassium sulfate (UNII: 1K573LC5TV)
edetate disodium (UNII: 7FLD91C86K)
sorbic acid (UNII: X045WJ989B)
chlorphenesin (UNII: I670DAL4SZ)
potassium sorbate (UNII: 1VPU26JZZ4)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-035-01	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/14/2010

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(49527-035) , REPACK(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(49527-035) , RELABEL(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(49527-035) , RELABEL(49527-035) , REPACK(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(49527-035)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(49527-035) , RELABEL(49527-035)