PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45- titanium dioxide and zinc oxide lotion

PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 by

Drug Labeling and Warnings

PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 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
Titanium Dioxide 6.3%	Sunscreen
Zinc Oxide 4.0%	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 dimethicone butyloctyl salicylate c12-15 alkyl benzoate methyl trimethicone isononyl isononanoate diethylhexyl succinate neopentyl glycol diheptanoate butylene glycol dipentaerythrityl tri-polyhydroxystearate lauryl peg-9 polydimethylsiloxyethyl dimethicone silica trimethylsiloxysilicate cetyl peg/ppg-10/1 dimethicone hydroxyapatite polygonum cuspidatum root extract hordeum vulgare (barley) extract\extrait d'orge triticum vulgare (wheat) germ extract thermus thermophillus ferment sodium hyaluronate opuntia tuna extract lilium tigrinum extract algae extract camellia sinensis (green tea) leaf extract anthemis nobilis (chamomile) flower extract caffeine tocopheryl acetate ergothioneine squalane glycerin dimethicone silylate hydrolyzed wheat protein/pvp crosspolymer dimethicone crosspolymer-3 glyceryl behenate/eicosadioate stearalkonium hectorite caprylyl glycol isostearic acid polyhydroxystearic acid tetrahexyldecyl ascorbate dipropylene glycol triethoxycaprylylsilane ethylbisiminomethylguaiacol manganese chloride cyclodextrin dimethicone/peg-10/15 crosspolymer isopropyl myristate propylene carbonate bht phenoxyethanol red 28 lake (ci 45410) blue 1 lake (ci 42090) <iln45003>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Container Carton

ESTĒE LAUDER

Perfectionist Pro

Multi-Defense UV Fluid
Broad Spectrum SPF 45
8 Anti-Oxidants

All Skintypes

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

PERFECTIONIST PRO MULTI-DEFENSE UV FLUID BROAD SPRECTRUM SPF 45 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	66.46 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	42.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butyloctyl salicylate (UNII: 2EH13UN8D3)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
methyl trimethicone (UNII: S73ZQI0GXM)
isononyl isononanoate (UNII: S4V5BS6GCX)
diethylhexyl succinate (UNII: 69W9UMG3P8)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
butylene glycol (UNII: 3XUS85K0RA)
dipentaerythrityl tri-polyhydroxystearate (UNII: D21K655H52)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
silicon dioxide (UNII: ETJ7Z6XBU4)
tribasic calcium phosphate (UNII: 91D9GV0Z28)
barley (UNII: 5PWM7YLI7R)
wheat (UNII: 4J2I0SN84Y)
thermus thermophilus lysate (UNII: 775R692494)
hyaluronate sodium (UNII: YSE9PPT4TH)
green tea leaf (UNII: W2ZU1RY8B0)
chamomile (UNII: FGL3685T2X)
caffeine (UNII: 3G6A5W338E)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ergothioneine (UNII: BDZ3DQM98W)
squalane (UNII: GW89575KF9)
glycerin (UNII: PDC6A3C0OX)
glyceryl behenate/eicosadioate (UNII: 73CJJ317SR)
stearalkonium hectorite (UNII: OLX698AH5P)
caprylyl glycol (UNII: 00YIU5438U)
isostearic acid (UNII: X33R8U0062)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
dipropylene glycol (UNII: E107L85C40)
triethoxycaprylylsilane (UNII: LDC331P08E)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
isopropyl myristate (UNII: 0RE8K4LNJS)
propylene carbonate (UNII: 8D08K3S51E)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
D&C red no. 28 (UNII: 767IP0Y5NH)
aluminum oxide (UNII: LMI26O6933)
FD&C blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-050-01	1 in 1 CARTON	10/05/2018
1		30 mL in 1 CONTAINER; 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	10/05/2018

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-050) , REPACK(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-050) , REPACK(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-050) , REPACK(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-050)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-050)