DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and octocrylene cream

DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15 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 2.0%	Sunscreen
Homosalate 4.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 2.0%	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 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 glycerin alcohol denat. pentylene glycol caprylyl methicone biosaccharide gum-1 ammonium acryloyldimethyltaurate/vp copolymer cucumis sativus (cucumber) fruit extract sodium hyaluronate thermus thermophillus ferment ethylbisiminomethylguaiacol manganese chloride ergothioneine tocopheryl acetate tetrahexyldecyl ascorbate cyclodextrin psidium guajava (guava) fruit extract fumaria officinalis flower/leaf/stem extract caffeine narcissus tazetta bulb extract polygonum cuspidatum root extract algae extract citrus limon (lemon) fruit extract helianthus annuus (sunflower) seedcake vitis vinifera (grape) seed extract triticum vulgare (wheat) germ extract hordeum vulgare (barley) extract\extrait d'orge gentiana lutea (gentian) root extract linoleic acid cholesterol glycyrrhetinic acid saccharomyces lysate extract palmitoyl hydroxypropyltrimonium amylopectin/glycerin crosspolymer artemia extract propylene glycol dicaprate fumaric acid ethylhexylglycerin propanediol squalane acrylates/c10-30 alkyl acrylate crosspolymer butylene glycol citric acid sodium hydroxide fragrance (parfum) disodium edta bht phenoxyethanol blue 1 (ci 42090) <iln45480>

Other information

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

PRINCIPAL DISPLAY PANEL - 50 ml Jar Carton

ESTĒE LAUDER

DayWear
Anti-Oxidant 72H-Hydration Sorbet Creme
Broad Spectrum SPF 15

Normal/Combination Skin

POIDS NET WT. 1.7 OZ./50 ml e

INGREDIENTS AND APPEARANCE

DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15 
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.0215 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.043 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.0484 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.0215 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
glycerin (UNII: PDC6A3C0OX)
pentylene glycol (UNII: 50C1307PZG)
caprylyl trisiloxane (UNII: Q95M2P1KJL)
biosaccharide gum-1 (UNII: BB4PU4V09H)
ammonium acryloyldimethyltaurate/vp copolymer (UNII: W59H9296ZG)
cucumber (UNII: YY7C30VXJT)
hyaluronate sodium (UNII: YSE9PPT4TH)
thermus thermophilus lysate (UNII: 775R692494)
ethylbisiminomethylguaiacol manganese chloride (UNII: SM5YJ88LTU)
ergothioneine (UNII: BDZ3DQM98W)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
guava (UNII: 74O70D6VG0)
caffeine (UNII: 3G6A5W338E)
lemon (UNII: 24RS0A988O)
helianthus annuus seedcake (UNII: 482WYF7XLC)
grape (UNII: 6X543N684K)
wheat (UNII: 4J2I0SN84Y)
barley (UNII: 5PWM7YLI7R)
linoleic acid (UNII: 9KJL21T0QJ)
cholesterol (UNII: 97C5T2UQ7J)
enoxolone (UNII: P540XA09DR)
propylene glycol dicaprate (UNII: U783H9JHWY)
fumaric acid (UNII: 88XHZ13131)
ethylhexylglycerin (UNII: 147D247K3P)
propanediol (UNII: 5965N8W85T)
squalane (UNII: GW89575KF9)
butylene glycol (UNII: 3XUS85K0RA)
citric acid monohydrate (UNII: 2968PHW8QP)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
FD&C blue no. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-055-01	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(11559-055) , REPACK(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-055) , REPACK(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-055) , REPACK(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-055)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-055)