ESTEE LAUDER MULTI-DEFENSE AQUA UV GEL BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by ESTEE LAUDER INC, Estee Lauder Companies Inc., Whitman Laboratories Ltd., ESTEE LAUDER COMPANY, THE, Estee Lauder Cosmetics Ltd., Estee Lauder N.V., NORTHTEC INC, NORTHTEC PALC, Len-Ron Manufacturing Division of Aramis Inc., 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
Homosalate 5.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 2.8%	Sunscreen
Oxybenzone 3.0%	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 alcohol denat. butylene glycol tocopheryl acetate sodium hyaluronate camellia sinensis (green tea) leaf extract anthemis nobilis (chamomile) flower extract algae extract triticum vulgare (wheat) germ extract laminaria ochroleuca extract polygonum cuspidatum root extract squalane hordeum vulgare (barley) extract\extrait d'orge lilium tigrinum extract opuntia tuna extract caffeine acrylates copolymer caprylic/capric triglyceride caprylyl glycol cholesterol ergothioneine glycerin sucrose alcaligenes polysaccharides thermus thermophillus ferment sorbitan sesquiisostearate tetrahexyldecyl ascorbate hexylene glycol acrylates/ beheneth-25 methacrylate copolymer sodium hydroxide dehydroxanthan gum dipropylene glycol carbomer ppg-8-ceteth-20 dextrin palmitate cyclodextrin acrylates/c10-30 alkyl acrylate crosspolymer sorbeth-30 tetraisostearate glyceryl stearate polymethylsilsesquioxane ammonium acryloyldimethyltaurate/vp copolymer bht ethylbisiminomethylguaiacol manganese chloride disodium edta phenoxyethanol
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Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

ESTĒE LAUDER

Perfectionist Pro
Multi-Defense Aqua UV Gel
Broad Spectrum SPF 50
8 Anti-Oxidants

All Skintypes

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

ESTEE LAUDER MULTI-DEFENSE AQUA UV GEL BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	28 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
1,2-BUTANEDIOL (UNII: RUN0H01QEU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
SARGASSUM FILIPENDULA (UNII: 55P66J5H7N)
WHEAT GERM (UNII: YR3G369F5A)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)
SQUALANE (UNII: GW89575KF9)
HORDEUM VULGARE ROOT (UNII: 790S39483Z)
LILIUM LANCIFOLIUM BULB (UNII: 47Z05W73EZ)
OPUNTIA TUNA WHOLE (UNII: DI94T5T0ZY)
CAFFEINE (UNII: 3G6A5W338E)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHOLESTEROL (UNII: 97C5T2UQ7J)
ERGOTHIONEINE (UNII: BDZ3DQM98W)
GLYCERIN (UNII: PDC6A3C0OX)
SUCROSE (UNII: C151H8M554)
ALCALIGENES FAECALIS (UNII: 05KB30NGW2)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PPG-2-CETETH-9 (UNII: 1OTA54V264)
DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3)
BETADEX (UNII: JV039JZZ3A)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PEG-10 SORBITAN LAURATE (UNII: 4Z93U4C2WN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-060-01	1 in 1 CARTON	05/08/2020
1		30 mL in 1 TUBE; 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	05/04/2020

Labeler - ESTEE LAUDER INC (005914387)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V		370151326	MANUFACTURE(11559-060)