ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30- homosalate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotion

ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30 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
Homosalate 5.00%	Sunscreen
Octisalate 5.00%	Sunscreen
Octocrylene 2.70%	Sunscreen
Oxybenzone 3.00%	Sunscreen
Titanium dioxide 1.90%	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 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 butyloctyl salicylate aleurites moluccana (kukui) seed oil lauryl peg-9 polydimethylsiloxyethyl dimethicone peg-100 stearate butylene glycol methyl trimethicone glyceryl stearate dipentaerythrityl tri-polyhydroxystearate synthetic fluorphlogopite cladosiphon okamuranus extract laminaria ochroleuca extract scutellaria baicalensis root extract glycyrrhiza glabra (licorice) root extract narcissus tazetta bulb extract hordeum vulgare (barley) extract\extrait d'orge whey protein\lactis protein\proteine du petit-lait cucumis sativus (cucumber) fruit extract yeast extract\faex\extrait de levure helianthus annuus (sunflower) seedcake cholesterol oryzanol sorbitol propylene glycol dicaprate potassium cetyl phosphate dextrin cetyl alcohol vp/eicosene copolymer saccharide isomerate caprylic/capric triglyceride caprylyl glycol ethylhexylglycerin lecithin caffeine ammonium acryloyldimethyltaurate/vp copolymer tocopheryl acetate sodium hyaluronate dehydroxanthan gum stearic acid silica citric acid potassium sorbate alumina fragrance (parfum) tin oxide tetrahexyldecyl ascorbate disodium edta bht phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499) mica] <iln40893>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

ESTĒE LAUDER

Enlighten
EE
Even Effect
Skintone Corrector
Broad Spectrum
SPF 30

All Skintypes

1 FL. OZ. LIQ./30 ml e

INGREDIENTS AND APPEARANCE

ENLIGHTEN EE EVEN EFFECT SKIN TONE CORRECTOR SPF BROAD SPECTRUM SPF 30 
homosalate, octisalate, octocrylene, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.0315 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0315 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.02835 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.0315 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.01995 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
butyloctyl salicylate (UNII: 2EH13UN8D3)
KUKUI NUT OIL (UNII: TP11QR7B8R)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
peg-100 stearate (UNII: YD01N1999R)
butylene glycol (UNII: 3XUS85K0RA)
methyl trimethicone (UNII: S73ZQI0GXM)
glyceryl monostearate (UNII: 230OU9XXE4)
cladosiphon okamuranus (UNII: 2IJE0CH09J)
laminaria ochroleuca (UNII: 4R2124HE76)
scutellaria baicalensis root (UNII: 7J95K7ID2S)
glycyrrhiza glabra (UNII: 2788Z9758H)
narcissus tazetta bulb (UNII: K17762966S)
barley (UNII: 5PWM7YLI7R)
whey (UNII: 8617Z5FMF6)
cucumber (UNII: YY7C30VXJT)
yeast, unspecified (UNII: 3NY3SM6B8U)
HELIANTHUS ANNUUS SEEDCAKE (UNII: 482WYF7XLC)
cholesterol (UNII: 97C5T2UQ7J)
gamma oryzanol (UNII: SST9XCL51M)
sorbitol (UNII: 506T60A25R)
propylene glycol dicaprate (UNII: U783H9JHWY)
potassium cetyl phosphate (UNII: 03KCY6P7UT)
icodextrin (UNII: 2NX48Z0A9G)
cetyl alcohol (UNII: 936JST6JCN)
saccharide isomerate (UNII: W8K377W98I)
medium-chain triglycerides (UNII: C9H2L21V7U)
caprylyl glycol (UNII: 00YIU5438U)
ethylhexylglycerin (UNII: 147D247K3P)
caffeine (UNII: 3G6A5W338E)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
hyaluronate sodium (UNII: YSE9PPT4TH)
stearic acid (UNII: 4ELV7Z65AP)
silicon dioxide (UNII: ETJ7Z6XBU4)
citric acid monohydrate (UNII: 2968PHW8QP)
potassium sorbate (UNII: 1VPU26JZZ4)
aluminum oxide (UNII: LMI26O6933)
stannic oxide (UNII: KM7N50LOS6)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
edetate disodium (UNII: 7FLD91C86K)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)
mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-043-01	1 in 1 CARTON	08/01/2014
1		30 mL in 1 BOTTLE; 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	08/01/2014

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-043) , REPACK(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V		370151326	MANUFACTURE(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-043) , REPACK(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-043) , REPACK(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-043)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-043)