VITAMIN E MOISTURIZING DAY SPF 15- avobenzone and octisalate cream

VITAMIN E MOISTURIZING DAY SPF 15 by

Drug Labeling and Warnings

VITAMIN E MOISTURIZING DAY SPF 15 by is a Otc medication manufactured, distributed, or labeled by JO MALONE LTD, 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

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., dimethicone, butyloctyl salicylate, butylene glycol, polyester-8, cetyl ricinoleate, steareth-21, steareth-2, di-c12-15 alkyl fumarate, caprylic/capric/myristic/stearic triglyceride, polysilicone-11, gentiana lutea (gentian) root extract, polygonum cuspidatum root extract, hordeum vulgare (barley) extract\extrait d'orge , triticum vulgare (wheat) germ extract, laminaria ochroleuca extract, hydrolyzed rice extract, fumaria officinalis flower/leaf/stem extract, citrus medica limonum (lemon) fruit extract, hydrolyzed rice bran extract, rosmarinus officinalis (rosemary) leaf extract, vitis vinifera (grape) seed extract, artemia extract, thermus thermophillus ferment, stearyl alcohol, pentylene glycol, polyquaternium-51, lauryl peg-9 polydimethylsiloxyethyl dimethicone, behenyl alcohol, triacontanyl pvp, glycerin, lecithin, c12-15 alkyl benzoate, linoleic acid, caffeine, cholesterol, squalane, sodium pca, acrylic acid/vp crosspolymer, urea, 1 ,2-hexanediol, caprylic/capric triglyceride, dipropylene glycol dibenzoate, tocopheryl acetate, tetrahexyldecyl ascorbate, sodium hyaluronate, ppg-15 stearyl ether benzoate, glycyrrhetinic acid, trehalose, hydrogenated lecithin, fumaric acid, palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer, cyclodextrin, nordihydroguaiaretic acid, ascorbyl tocopheryl maleate, caprylyl glycol, ergothioneine, sodium chloride, fragrance (parfum), sodium hydroxide, citric acid, ethylbisiminomethylguaiacol manganese chloride, disodium edta, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sodium dehydroacetate, phenoxyethanol <iln37878>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 mL Jar Label

Jo MALONE

LONDON

VITAMIN E MOISTURISING DAY CRÈME SPF 15

INGREDIENTS AND APPEARANCE

VITAMIN E MOISTURIZING DAY SPF 15 
avobenzone and octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62874-006
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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
dimethicone (UNII: 92RU3N3Y1O)
butyloctyl salicylate (UNII: 2EH13UN8D3)
butylene glycol (UNII: 3XUS85K0RA)
polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) (UNII: T9296U138P)
cetyl ricinoleate (UNII: 1P677500YD)
steareth-21 (UNII: 53J3F32P58)
steareth-2 (UNII: V56DFE46J5)
di-c12-15 alkyl fumarate (UNII: A1CB3Z898P)
barley (UNII: 5PWM7YLI7R)
wheat (UNII: 4J2I0SN84Y)
lemon (UNII: 24RS0A988O)
rosemary (UNII: IJ67X351P9)
grape (UNII: 6X543N684K)
thermus thermophilus lysate (UNII: 775R692494)
stearyl alcohol (UNII: 2KR89I4H1Y)
pentylene glycol (UNII: 50C1307PZG)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
docosanol (UNII: 9G1OE216XY)
tricontanyl povidone (UNII: N0SS3Q238D)
glycerin (UNII: PDC6A3C0OX)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
linoleic acid (UNII: 9KJL21T0QJ)
caffeine (UNII: 3G6A5W338E)
cholesterol (UNII: 97C5T2UQ7J)
squalane (UNII: GW89575KF9)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
urea (UNII: 8W8T17847W)
1,2-hexanediol (UNII: TR046Y3K1G)
medium-chain triglycerides (UNII: C9H2L21V7U)
dipropylene glycol dibenzoate (UNII: 6OA5ZDY41O)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
hyaluronate sodium (UNII: YSE9PPT4TH)
ppg-15 stearyl ether benzoate (UNII: 80D2J6361M)
enoxolone (UNII: P540XA09DR)
trehalose (UNII: B8WCK70T7I)
hydrogenated soybean lecithin (UNII: H1109Z9J4N)
fumaric acid (UNII: 88XHZ13131)
ascorbyl tocopheryl maleate (UNII: D2G6259XR5)
caprylyl glycol (UNII: 00YIU5438U)
ergothioneine (UNII: BDZ3DQM98W)
sodium chloride (UNII: 451W47IQ8X)
sodium hydroxide (UNII: 55X04QC32I)
citric acid monohydrate (UNII: 2968PHW8QP)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
sodium dehydroacetate (UNII: 8W46YN971G)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62874-006-01	50 mL in 1 JAR; Type 0: Not a Combination Product	09/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2011

Labeler - JO MALONE LTD (347366049)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(62874-006) , REPACK(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(62874-006) , REPACK(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(62874-006) , REPACK(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(62874-006)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(62874-006)