SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY)- avobenzone and octisalate cream

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY) by

Drug Labeling and Warnings

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY) 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

Avobenzone 3.0%
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 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 butyloctyl salicylate glycerin polyester-8 polysorbate 60 dimethicone butylene glycol cetyl alcohol sorbitan stearate tridecyl stearate peg-100 stearate trehalose sigesbeckia orientalis (st. paul's wort) extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract arabidopsis thaliana extract laminaria saccharina extract plankton extract algae extract sea whip extract lactobacillus ferment micrococcus lysate ergothioneine caffeine lecithin sodium hyaluronate pentylene glycol tridecyl trimellitate dipentaerythrityl hexacaprylate/hexacaprate tocopheryl acetate ethylhexylglycerin squalane cetyl palmitate acrylates/c10-30 alkyl acrylate crosspolymer sorbitan palmitate sorbitan olivate polyethylene sodium benzoate ethylene/va copolymer tetrahexyldecyl ascorbate dimethiconol sodium polyacrylate sodium hydroxide pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate disodium edta phenoxyethanol chlorphenesin [iln39715]

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Carton

age prevention

C

CLINIQUE

superdefense

daily defense moisturizer
broad spectrum SPF 20

COMBINATION OILY TO OILY

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (COMBINATION OILY - OILY) 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
butyloctyl salicylate (UNII: 2EH13UN8D3)
glycerin (UNII: PDC6A3C0OX)
polysorbate 60 (UNII: CAL22UVI4M)
dimethicone (UNII: 92RU3N3Y1O)
butylene glycol (UNII: 3XUS85K0RA)
cetyl alcohol (UNII: 936JST6JCN)
sorbitan monostearate (UNII: NVZ4I0H58X)
tridecyl stearate (UNII: A8OE252M6L)
peg-100 stearate (UNII: YD01N1999R)
trehalose (UNII: B8WCK70T7I)
wheat germ (UNII: YR3G369F5A)
saccharina latissima (UNII: 68CMP2MB55)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
ergothioneine (UNII: BDZ3DQM98W)
caffeine (UNII: 3G6A5W338E)
hyaluronate sodium (UNII: YSE9PPT4TH)
pentylene glycol (UNII: 50C1307PZG)
tridecyl trimellitate (UNII: FY36J270ES)
dipentaerythrityl hexacaprylate/hexacaprate (UNII: 554N82UWVW)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ethylhexylglycerin (UNII: 147D247K3P)
squalane (UNII: GW89575KF9)
cetyl palmitate (UNII: 5ZA2S6B08X)
sorbitan monopalmitate (UNII: 77K6Z421KU)
sorbitan olivate (UNII: MDL271E3GR)
high density polyethylene (UNII: UG00KM4WR7)
sodium benzoate (UNII: OJ245FE5EU)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
sodium hydroxide (UNII: 55X04QC32I)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-037-01	1 in 1 CARTON	10/01/2013
1		50 mL in 1 JAR; 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	10/01/2013

Labeler - CLINIQUE LABORATORIES LLC (044475127)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(49527-037) , REPACK(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-037) , REPACK(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-037) , REPACK(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-037)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-037)