RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene cream

RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER 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 INGREDIENT

Active ingredients	Purpose
Avobenzone 3.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	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 neopentyl glycol diheptanoate cetyl alcohol pentaerythrityl tetraethylhexanoate glycerin polyethylene butyloctyl salicylate di-c12-15 alkyl fumarate petrolatum hydrogenated lecithin butylene glycol propanediol hydrogenated polyisobutene octyldodecyl myristate hexyldecyl stearate dimethicone glyceryl stearate laminaria digitata extract behenyl alcohol algae extract persea gratissima (avocado) oil coleus barbatus extract cucumis melo (melon) fruit extract potato starch modified mimosa tenuiflora bark extract yeast extract\faex\extrait de levure plankton extract aminopropyl ascorbyl phosphate thermus thermophillus ferment saccharomyces ferment lysate filtrate artemia extract c12-16 alcohols acetyl glucosamine linoleic acid whey protein\lactis protein\proteine du petit-lait peg-100 stearate tocopheryl acetate caffeine ergothioneine glycine soja (soybean) sterols decarboxy carnosine hcl palmitic acid creatine ethylhexylglycerin polymethyl methacrylate trehalose glucose sodium hyaluronate sorbitol zinc pca cholesterol malachite acetyl hexapeptide-8 maltodextrin lecithin acrylamide/sodium acryloyldimethyltaurate copolymer isohexadecane sodium hydroxide polysorbate 80 lactoperoxidase hexylene glycol hydrogenated starch hydrolysate potassium sulfate glucose oxidase polysilicone-11 propylene glycol dicaprylate xanthan gum caprylyl glycol citric acid fragrance (parfum) bht disodium edta phenoxyethanol potassium sorbate mica titanium dioxide (ci 77891) red 4 (ci 14700) yellow 5 (ci 19140) <iln39076>

Other information

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

SPL UNCLASSIFIED SECTION

© ESTĒE LAUDER, DIST., NEW YORK, N.Y. 10022

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

EL

ESTĒE LAUDER

Resilience Lift
Firming/Sculpting Face and Neck Creme
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50ml e

INGREDIENTS AND APPEARANCE

RESILIENCE LIFT FIRMING SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0312 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.052 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02808 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
cetyl alcohol (UNII: 936JST6JCN)
pentaerythrityl tetraethylhexanoate (UNII: XJ7052W897)
glycerin (UNII: PDC6A3C0OX)
high density polyethylene (UNII: UG00KM4WR7)
butyloctyl salicylate (UNII: 2EH13UN8D3)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
petrolatum (UNII: 4T6H12BN9U)
butylene glycol (UNII: 3XUS85K0RA)
propanediol (UNII: 5965N8W85T)
octyldodecyl myristate (UNII: S013N99GR8)
hexyldecyl stearate (UNII: OJX2P28Y14)
dimethicone (UNII: 92RU3N3Y1O)
glyceryl monostearate (UNII: 230OU9XXE4)
laminaria digitata (UNII: 15E7C67EE8)
docosanol (UNII: 9G1OE216XY)
avocado oil (UNII: 6VNO72PFC1)
muskmelon (UNII: ZV095H5633)
mimosa tenuiflora bark (UNII: 515MQE449I)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
thermus thermophilus lysate (UNII: 775R692494)
c12-16 alcohols (UNII: S4827SZE3L)
n-acetylglucosamine (UNII: V956696549)
linoleic acid (UNII: 9KJL21T0QJ)
peg-100 stearate (UNII: YD01N1999R)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
caffeine (UNII: 3G6A5W338E)
ergothioneine (UNII: BDZ3DQM98W)
soy sterol (UNII: PL360EPO9J)
decarboxy carnosine Hydrochloride (UNII: 6X7K9I5QR7)
palmitic acid (UNII: 2V16EO95H1)
creatine (UNII: MU72812GK0)
ethylhexylglycerin (UNII: 147D247K3P)
trehalose (UNII: B8WCK70T7I)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
hyaluronate sodium (UNII: YSE9PPT4TH)
sorbitol (UNII: 506T60A25R)
zinc pidolate (UNII: C32PQ86DH4)
cholesterol (UNII: 97C5T2UQ7J)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
maltodextrin (UNII: 7CVR7L4A2D)
isohexadecane (UNII: 918X1OUF1E)
sodium hydroxide (UNII: 55X04QC32I)
polysorbate 80 (UNII: 6OZP39ZG8H)
hexylene glycol (UNII: KEH0A3F75J)
potassium sulfate (UNII: 1K573LC5TV)
glucose oxidase (UNII: 0T8392U5N1)
propylene glycol dicaprylate (UNII: 581437HWX2)
xanthan gum (UNII: TTV12P4NEE)
caprylyl glycol (UNII: 00YIU5438U)
citric acid monohydrate (UNII: 2968PHW8QP)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
potassium sorbate (UNII: 1VPU26JZZ4)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
fd&c red no. 4 (UNII: X3W0AM1JLX)
fd&c yellow no. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-018-01	1 in 1 CARTON	10/12/2010
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	10/12/2010

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-018) , REPACK(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-018) , REPACK(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-018) , REPACK(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-018)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-018)