SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20- titanium dioxide and zinc oxide cream

SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by CLINIQUE LABORATORIES INC., ESTEE LAUDER COMPANY, THE, ESTEE LAUDER COSMETICS, LTD, ESTEE LAUDER COSMETICS, LTD., ESTEE LAUDER N.V., LEN-RON MANUFACTURING DIVISION OF ARAMIS INC, NORTHTEC INC, PADC 1, WHITMAN LABORATORIES, LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Titanium dioxide 5.6%
Zinc oxide 3.8%

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 isocetyl stearoyl stearate c12-15 alkyl benzoate butylene glycol cetyl alcohol butyrospermum parkii (shea butter) dimethicone laureth-4 cetyl esters peg-100 stearate polyethylene rosmarinus officinalis (rosemary) leaf extract sea whip extract padina pavonica thallus extract sigesbeckia orientalis (st. paul's wort) extract algae extract lecithin micrococcus lysate caffeine astrocaryum murumuru seed butter isohexadecane tocopheryl acetate trehalose glycerin isostearic acid caprylyl glycol polyhydroxystearic acid polysorbate 80 phytosphingosine tetrahexyldecyl ascorbate sodium rna lauric acid linoleic acid sodium hyaluronate hydrogenated lecithin ascorbyl tocopheryl maleate chamomilla recutita (matricaria) acrylamide/sodium acryloyldimethyltaurate copolymer hexylene glycol nordihydroguaiaretic acid tromethamine aluminum hydroxide disodium edta phenoxyethanol mica iron oxides (ci 77491, ci 77492, ci 77499) [iln38727]

Other information

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

PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

age prevention

C
CLINIQUE

superdefense

age defense
eye cream
broad spectrum
SPF 20

ALL SKIN TYPES

.5 FL.OZ.LIQ./15 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE AGE DEFENSE BROAD SPECTRUM SPF 20 
titanium dioxide and zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.060217 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.040861 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
isocetyl stearoyl stearate (UNII: IJV4LS383R)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
cetyl alcohol (UNII: 936JST6JCN)
shea butter (UNII: K49155WL9Y)
dimethicone (UNII: 92RU3N3Y1O)
laureth-4 (UNII: 6HQ855798J)
cetyl esters wax (UNII: D072FFP9GU)
peg-100 stearate (UNII: YD01N1999R)
high density polyethylene (UNII: UG00KM4WR7)
rosemary (UNII: IJ67X351P9)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
padina pavonica (UNII: 177U06NHZI)
caffeine (UNII: 3G6A5W338E)
astrocaryum murumuru seed butter (UNII: 12V64UPU6R)
isohexadecane (UNII: 918X1OUF1E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
trehalose (UNII: B8WCK70T7I)
glycerin (UNII: PDC6A3C0OX)
isostearic acid (UNII: X33R8U0062)
caprylyl glycol (UNII: 00YIU5438U)
polysorbate 80 (UNII: 6OZP39ZG8H)
phytosphingosine (UNII: GIN46U9Q2Q)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
lauric acid (UNII: 1160N9NU9U)
linoleic acid (UNII: 9KJL21T0QJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
hexylene glycol (UNII: KEH0A3F75J)
masoprocol (UNII: 7BO8G1BYQU)
tromethamine (UNII: 023C2WHX2V)
aluminum hydroxide (UNII: 5QB0T2IUN0)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-036-01	1 in 1 CARTON	09/01/2013
1		15 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	09/01/2013

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-036) , REPACK(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-036) , REPACK(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-036) , REPACK(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-036)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-036)