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

RESILIENCE LIFT FIRMING- SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 FOR DRY SKIN by

Drug Labeling and Warnings

RESILIENCE LIFT FIRMING- SCULPTING FACE AND NECK BROAD SPECTRUM SPF 15 FOR DRY SKIN 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 olea europaea (olive) fruit oil cetyl ricinoleate butyrospermum parkii (shea butter) butylene glycol ppg-51/smdi copolymer cetyl esters dimethicone methyl gluceth-20 glycereth-26 butyloctyl salicylate glyceryl stearate propanediol peg-100 stearate behenyl alcohol olea europaea (olive) fruit extract triticum vulgare (wheat bran) extract persea gratissima (avocado) oil yeast extract\faex\extrait de levure cucumis melo (melon) fruit extract laminaria digitata extract artemia extract algae extract mimosa tenuiflora bark extract aminopropopyl ascorbyl phosphate plankton extract acetyl glucosamine triacontanyl pvp acetyl hexapeptide-8 decarboxy carnosine hcl ethylhexylglycerin linoleic acid sodium hyaluronate whey protein\lactis protein\proteine du petit-lait caffeine tocopheryl acetate thermus thermophillus ferment saccharomyces ferment lysate filtrate sodium hydroxide ergothioneine polymethyl methacrylate zinc pca trehalose ethyhexyl hydroxystearate sorbitol simethicone acrylamide/sodium acryloyldimethyltaurate copolymer hydrogenated starch hydrolysate cholesterol glycerin malachite carbomer potassium sulfate citric acid maltodextrin lecithin propylene glycol dicaprylate isohexadecane acrylates/c10-30 alkyl acrylate crosspolymer hexylene glycol xanthan gum polysorbate 80 fragrance (parfum) caprylyl glycol pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate bht potassium sorbate sodium dehydroacetate phenoxyethanol mica iron oxides (ci 77491, ci 77492, ci 77499) titanium dioxide (ci 77891 <iln39074>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

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

Dry Skin

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-028
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.027 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
olive oil (UNII: 6UYK2W1W1E)
cetyl ricinoleate (UNII: 1P677500YD)
shea butter (UNII: K49155WL9Y)
butylene glycol (UNII: 3XUS85K0RA)
ppg-51/smdi copolymer (UNII: KQ9JG3O3YA)
cetyl esters wax (UNII: D072FFP9GU)
dimethicone (UNII: 92RU3N3Y1O)
methyl gluceth-20 (UNII: J3QD0LD11P)
glycereth-26 (UNII: NNE56F2N14)
butyloctyl salicylate (UNII: 2EH13UN8D3)
glyceryl monostearate (UNII: 230OU9XXE4)
propanediol (UNII: 5965N8W85T)
peg-100 stearate (UNII: YD01N1999R)
docosanol (UNII: 9G1OE216XY)
black olive (UNII: 2M6QWV94OC)
wheat bran (UNII: 6L966A1IMR)
avocado oil (UNII: 6VNO72PFC1)
yeast, unspecified (UNII: 3NY3SM6B8U)
muskmelon (UNII: ZV095H5633)
laminaria digitata (UNII: 15E7C67EE8)
mimosa tenuiflora bark (UNII: 515MQE449I)
aminopropyl ascorbyl phosphate (UNII: 290O2PQ83R)
n-acetylglucosamine (UNII: V956696549)
tricontanyl povidone (UNII: N0SS3Q238D)
acetyl hexapeptide-8 (UNII: L4EL31FWIL)
decarboxy carnosine hydrochloride (UNII: 6X7K9I5QR7)
ethylhexylglycerin (UNII: 147D247K3P)
linoleic acid (UNII: 9KJL21T0QJ)
hyaluronate sodium (UNII: YSE9PPT4TH)
caffeine (UNII: 3G6A5W338E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
thermus thermophilus lysate (UNII: 775R692494)
sodium hydroxide (UNII: 55X04QC32I)
ergothioneine (UNII: BDZ3DQM98W)
poly(methyl methacrylate; 450000 mw) (UNII: Z47NNT4J11)
zinc pidolate (UNII: C32PQ86DH4)
trehalose (UNII: B8WCK70T7I)
ethylhexyl hydroxystearate (UNII: B7I80BVV5E)
sorbitol (UNII: 506T60A25R)
hydrogenated starch hydrolysate (UNII: 27F77DSJ5V)
cholesterol (UNII: 97C5T2UQ7J)
glycerin (UNII: PDC6A3C0OX)
carboxypolymethylene (UNII: 0A5MM307FC)
potassium sulfate (UNII: 1K573LC5TV)
citric acid monohydrate (UNII: 2968PHW8QP)
maltodextrin (UNII: 7CVR7L4A2D)
propylene glycol dicaprylate (UNII: 581437HWX2)
isohexadecane (UNII: 918X1OUF1E)
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)
hexylene glycol (UNII: KEH0A3F75J)
xanthan gum (UNII: TTV12P4NEE)
polysorbate 80 (UNII: 6OZP39ZG8H)
caprylyl glycol (UNII: 00YIU5438U)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
potassium sorbate (UNII: 1VPU26JZZ4)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)
mica (UNII: V8A1AW0880)
ferric oxide red (UNII: 1K09F3G675)
ferric oxide yellow (UNII: EX438O2MRT)
ferrosoferric oxide (UNII: XM0M87F357)
titanium dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-028-01	1 in 1 CARTON	07/01/2013
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	07/01/2013

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-028) , REPACK(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-028) , REPACK(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-028) , REPACK(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-028)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-028)