SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY- octisalate, oxybenzone, and avobenzone cream

SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY by

Drug Labeling and Warnings

SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY 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 3.0%
Octisalate 5.0%
Oxybenzone 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 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 dimethicone petrolatum butylene glycol butyloctyl salicylate polyglyceryl-2 triisostearate caprylic/capric/myristic/stearic triglyceride polyester-8 glyceryl stearate peg-100 stearate coffea robusta seed extract echinacea pallida (coneflower) extract rosmarinus officinalis (rosemary) extract sea whip extract isopropyl ppg-2-isodeceth-7 carboxylate padina pavonica (thallus) extract micrococcus lysate disodium nadh trehalose creatine sodium rna caffeine nordihydroguaiaretic acid sodium dna astrocaryum murumuru seed butter phytosphingosine linoleic acid cholesterol ascorbyl tocopheryl maleate algae extract sodium hyaluronate aminopropyl ascorbyl phosphate tocopheryl acetate adenosine phosphate laurdimonium hydroxypropyl hydrolyzed soy protein chamomilla recutita (matricaria) decarboxy carnosine hcl ethylhexyl stearate caprylyl glycol isohexadecane polyethylene zeolite lecithin behenyl alcohol xanthan gum potassium sulfate polysorbate 80 steareth-21 acrylamide/sodium acryloyldimethyltaurate copolymer ammonium acryloyldimethyltaurate/vp copolymer sucrose tromethamine carbomer glycerin ethylhexyl palmitate arginine ferulate propylene glycol dicaprate hexylene glycol disodium edta phenoxyethanol [iln36954]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

C

CLINIQUE

superdefense

age defense moisturizer
broad spectrum SPF 25

VERY DRY TO DRY

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE AGE DEFENSE MOISTURIZER BROAD SPECTRUM SPF 25 VERY DRY TO DRY 
octisalate, oxybenzone, and avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0508 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0508 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0305 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
petrolatum (UNII: 4T6H12BN9U)
butylene glycol (UNII: 3XUS85K0RA)
butyloctyl salicylate (UNII: 2EH13UN8D3)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
robusta coffee bean (UNII: V5032728L7)
echinacea pallida (UNII: 904CK3270L)
rosemary (UNII: IJ67X351P9)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
padina pavonica (UNII: 177U06NHZI)
trehalose (UNII: B8WCK70T7I)
creatine (UNII: MU72812GK0)
caffeine (UNII: 3G6A5W338E)
masoprocol (UNII: 7BO8G1BYQU)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
phytosphingosine (UNII: GIN46U9Q2Q)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
hyaluronate sodium (UNII: YSE9PPT4TH)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
adenosine phosphate (UNII: 415SHH325A)
decarboxy carnosine Hydrochloride (UNII: 6X7K9I5QR7)
ethylhexyl stearate (UNII: EG3PA2K3K5)
caprylyl glycol (UNII: 00YIU5438U)
isohexadecane (UNII: 918X1OUF1E)
high density polyethylene (UNII: UG00KM4WR7)
docosanol (UNII: 9G1OE216XY)
xanthan gum (UNII: TTV12P4NEE)
potassium sulfate (UNII: 1K573LC5TV)
polysorbate 80 (UNII: 6OZP39ZG8H)
steareth-21 (UNII: 53J3F32P58)
sucrose (UNII: C151H8M554)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
tromethamine (UNII: 023C2WHX2V)
glycerin (UNII: PDC6A3C0OX)
ethylhexyl palmitate (UNII: 2865993309)
propylene glycol dicaprate (UNII: U783H9JHWY)
hexylene glycol (UNII: KEH0A3F75J)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-034-01	1 in 1 CARTON
1		50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	06/01/2010

Labeler - CLINIQUE LABORATORIES INC. (173047747)

Establishment
Name	Address	ID/FEI	Business Operations
ELGC K.K.		712808195	RELABEL(49527-034) , REPACK(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
Estee Lauder Pennsylvania Distribution Center 2 (PADC 2)		828534516	MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS DISTRIBUTION CENTER		208579636	REPACK(49527-034) , RELABEL(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		205952385	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
NORTEC KEYSTONE		943871157	MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC BRISTOL		959338336	MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC KEYSTONE		949264774	MANUFACTURE(49527-034) , RELABEL(49527-034) , REPACK(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
Aveda Corporation		071352058	MANUFACTURE(49527-034)

Establishment
Name	Address	ID/FEI	Business Operations
Pennsylvania Logistics Center		078364654	REPACK(49527-034) , RELABEL(49527-034)