RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 DRY SKIN- avobenzone, octisalate, and octocrylene cream

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skin by

Drug Labeling and Warnings

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 dry skin by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., PALC, Estee Lauder Cosmetics Ltd., Whitman Laboratories Ltd., Estee Lauder N.V., The Estee Lauder Inc, Northtec LLC, PADC 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 2.7%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

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 and evenly 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 cucumis melo (melon) fruit extract polygonum aviculare extract triticum vulgare (wheat bran) extract olea europaea (olive) fruit extract sigesbeckia orientalis (st. paul's wort) extract aminopropyl ascorbyl phosphate cholesterol algae extract laminaria digitata extract myrtus communis leaf extract glycerin trifluoroacetyl tripeptide-2 acetyl hexapeptide-8 caffeine propylene glycol dicaprylate persea gratissima (avocado) oil artemia extract behenyl alcohol ethylhexyl hydroxystearate triacontanyl pvp tocopheryl acetate sodium hyaluronate trehalose ethylhexylglycerin fragrance (parfum) acetyl glucosamine tetradecyl aminobutyroylvalylaminobutyric urea trifluoroacetate decarboxy carnosine hcl acrylates/c10-30 alkyl acrylate crosspolymer isohexadecane polymethyl methacrylate caprylyl glycol zinc pca simethicone citric acid polysorbate 80 yeast extract\faex\extrait de levure sodium hydroxide xanthan gum carbomer acrylamide/sodium acryloyldimethyltaurate copolymer hexylene glycol potassium sulfate pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate dextran disodium edta bht sodium dehydroacetate phenoxyethanol mica red 4 (ci 14700) titanium dioxide (ci 77891) yellow 5 (ci 19140) <iln44780>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

Resilience Multi-Effect
Tri-Peptide Face and Neck Creme
Broad Spectrum SPF 15

Dry Skin

NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

RESILIENCE MULTI-EFFECT TRI-PEPTIDE FACE AND NECK CREME BROAD SPECTRUM SPF 15 DRY SKIN 
avobenzone, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-053
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	0.045 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)
MELON (UNII: 5CIT1X6U5V)
WHEAT BRAN (UNII: 6L966A1IMR)
AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)
CHOLESTEROL (UNII: 97C5T2UQ7J)
GLYCERIN (UNII: PDC6A3C0OX)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
CAFFEINE (UNII: 3G6A5W338E)
PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)
AVOCADO OIL (UNII: 6VNO72PFC1)
DOCOSANOL (UNII: 9G1OE216XY)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ZINC PIDOLATE (UNII: C32PQ86DH4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
POTASSIUM SULFATE (UNII: 1K573LC5TV)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICA (UNII: V8A1AW0880)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-053-01	1 in 1 CARTON	12/01/2018
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	12/01/2018

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-053) , REPACK(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-053) , REPACK(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-053) , REPACK(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-053)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-053)