DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30- octinoxate, titanium dioxide, and zinc oxide liquid

DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30 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
Octinoxate 5.0%	Sunscreen
Titanium Dioxide 3.1%	Sunscreen
Zinc Oxide 2.2%	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 methyl trimethicone phenyl trimethicone silica butyloctyl salicylate dimethicone neopentyl glycol diheptanoate c12-15 alkyl benzoate butylene glycol dimethicone silylate lauryl peg-9 polydimethylsiloxyethyl dimethicone ethylhexyl palmitate glycerin polysilicone-11 litchi chinensis seed extract peg-10 dimethicone laminaria saccharina extract polyglutamic acid lens esculenta (lentil) fruit extract pyrus malus (apple) fruit extract thermus thermophillus ferment citrullus vulgaris (watermelon) fruit extract sodium hyaluronate sodium lactate sodium chloride glycine soja (soybean) protein tocopheryl acetate zinc stearate caprylyl glycol sodium pca lecithin dimethicone/peg-10/15 crosspolymer trimethylsiloxysilicate laureth-7 triethyl citrate triethoxycaprylylsilane hexylene glycol silica dimethyl silylate disteardimonium hectorite calcium chloride sodium dehydroacetate potassium sorbate magnesium aluminum silicate xanthan gum dextrin disodium edta bht phenoxyethanol [+/- titanium dioxide (ci 77891) iron oxides (ci 77492) iron oxides (ci 77491) iron oxides (ci 77499)] <iln43610>

Other information

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

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

ESTĒE LAUDER

Double Wear
Nude

Water Fresh Makeup

Broad Spectrum SPF 30

1 FL. OZ. LIQ./30ml e

INGREDIENTS AND APPEARANCE

DOUBLE WEAR NUDE WATER FRESH MAKEUP BROAD SPECTRUM SPF 30 
octinoxate, titanium dioxide, and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11559-048
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.056 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.035 g  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.025 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
methyl trimethicone (UNII: S73ZQI0GXM)
phenyl trimethicone (UNII: DR0K5NOJ4R)
silicon dioxide (UNII: ETJ7Z6XBU4)
butyloctyl salicylate (UNII: 2EH13UN8D3)
dimethicone (UNII: 92RU3N3Y1O)
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
butylene glycol (UNII: 3XUS85K0RA)
lauryl peg-9 polydimethylsiloxyethyl dimethicone (UNII: 25G622K2RA)
ethylhexyl palmitate (UNII: 2865993309)
glycerin (UNII: PDC6A3C0OX)
dimethicone/vinyl dimethicone crosspolymer (soft particle) (UNII: 9E4CO0W6C5)
litchi chinensis seed (UNII: 9294024N9Q)
peg-10 dimethicone (600 cst) (UNII: 8PR7V1SVM0)
saccharina latissima (UNII: 68CMP2MB55)
lens culinaris fruit (UNII: ZYZ076G9JH)
apple (UNII: B423VGH5S9)
thermus thermophilus lysate (UNII: 775R692494)
watermelon (UNII: 231473QB6R)
hyaluronate sodium (UNII: YSE9PPT4TH)
sodium lactate (UNII: TU7HW0W0QT)
sodium chloride (UNII: 451W47IQ8X)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
zinc stearate (UNII: H92E6QA4FV)
caprylyl glycol (UNII: 00YIU5438U)
sodium pyrrolidone carboxylate (UNII: 469OTG57A2)
laureth-7 (UNII: Z95S6G8201)
triethyl citrate (UNII: 8Z96QXD6UM)
triethoxycaprylylsilane (UNII: LDC331P08E)
hexylene glycol (UNII: KEH0A3F75J)
silica dimethyl silylate (UNII: EU2PSP0G0W)
disteardimonium hectorite (UNII: X687XDK09L)
calcium chloride (UNII: M4I0D6VV5M)
sodium dehydroacetate (UNII: 8W46YN971G)
potassium sorbate (UNII: 1VPU26JZZ4)
magnesium aluminum silicate (UNII: 6M3P64V0NC)
xanthan gum (UNII: TTV12P4NEE)
edetate disodium anhydrous (UNII: 8NLQ36F6MM)
butylated hydroxytoluene (UNII: 1P9D0Z171K)
phenoxyethanol (UNII: HIE492ZZ3T)
ferric oxide yellow (UNII: EX438O2MRT)
ferric oxide red (UNII: 1K09F3G675)
ferrosoferric oxide (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11559-048-01	1 in 1 CARTON	05/01/2017
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	05/01/2017

Labeler - ESTEE LAUDER INC (005914387)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COMPANY, THE		828534516	RELABEL(11559-048) , REPACK(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER N.V.		370151326	MANUFACTURE(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
NORTHTEC INC		943871157	RELABEL(11559-048) , REPACK(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
PADC 1		949264774	RELABEL(11559-048) , REPACK(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE(11559-048)

Establishment
Name	Address	ID/FEI	Business Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE(11559-048)