SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB)- avobenzone and octisalate cream

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB) by

Drug Labeling and Warnings

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB) 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

• 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 butyrospermum parkii (shea butter) butyloctyl salicylate dimethicone petrolatum polyester-8 cetearyl alcohol glyceryl stearate peg-100 stearate butylene glycol glycerin trehalose sigesbeckia orientalis (st. paul's wort) extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract arabidopsis thaliana extract plankton extract algae extract sea whip extract lactobacillus ferment micrococcus lysate ergothioneine caffeine lecithin sodium hyaluronate isohexadecane potassium cetyl phosphate tocopheryl acetate ethylhexylglycerin squalane caprylyl glycol acrylamide/sodium acryloyldimethyltaurate copolymer acrylates/c10-30 alkyl acrylate crosspolymer polyethylene tetrahexyldecyl ascorbate dimethiconol polysorbate 80 zeolite xanthan gum pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate tromethamine disodium edta phenoxyethanol [iln39713]

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

VERY DRY TO DRY COMBINATION

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

SUPERDEFENSE DAILY DEFENSE MOISTURIZER BROAD SPECTRUM SPF20 (VERY DRY - DRY COMB) 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49527-039
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)
SHEA BUTTER (UNII: K49155WL9Y)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dimethicone (UNII: 92RU3N3Y1O)
petrolatum (UNII: 4T6H12BN9U)
cetostearyl alcohol (UNII: 2DMT128M1S)
glyceryl monostearate (UNII: 230OU9XXE4)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
glycerin (UNII: PDC6A3C0OX)
trehalose (UNII: B8WCK70T7I)
BARLEY (UNII: 5PWM7YLI7R)
WHEAT GERM (UNII: YR3G369F5A)
pseudopterogorgia elisabethae (UNII: UDY3H1OUX5)
ergothioneine (UNII: BDZ3DQM98W)
caffeine (UNII: 3G6A5W338E)
hyaluronate sodium (UNII: YSE9PPT4TH)
isohexadecane (UNII: 918X1OUF1E)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ethylhexylglycerin (UNII: 147D247K3P)
squalane (UNII: GW89575KF9)
caprylyl glycol (UNII: 00YIU5438U)
high density polyethylene (UNII: UG00KM4WR7)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
polysorbate 80 (UNII: 6OZP39ZG8H)
xanthan gum (UNII: TTV12P4NEE)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
tromethamine (UNII: 023C2WHX2V)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49527-039-01	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(49527-039) , REPACK(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(49527-039) , REPACK(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(49527-039) , REPACK(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(49527-039)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(49527-039)