LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W VERY DEEP WARM- octinoxate, titanium dioxide emulsion

LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W VERY DEEP WARM by

Drug Labeling and Warnings

LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W VERY DEEP WARM by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Octinoxate 3.99%

Titanium Dioxide 3.04%

Purpose

sunscreen

Uses

• 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 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: Ask a doctor.

Question or comments?

In USA: 19 East, 57th Street, New York, NY 10022 855 454 6242 Monday through Friday 9am to 5pm EST.

Inactive ingredients

CYCLOPENTASILOXANE ISODODECANE AQUA (WATER) ALCOHOL TRIMETHYLSILOXYSILICATE PEG-9 POLYDIMETHYLSILOXYETHYL
DIMETHICONE DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER PHENYL TRIMETHICONE
POLYSILICONE-11 SYNTHETIC FLUORPHLOGOPITE GLYCERIN METHYL METHACRYLATE CROSSPOLYMER SILICA ECYLOXAZOLIDINONE
ALUMINUM HYDROXIDE DISTEARDIMONIUM HECTORITE PARFUM (FRAGRANCE) ISOSTEARIC ACID PHENOXYETHANOL GLYCERYL UNDECYL DIMETHICONE POLYHYDROXYSTEARIC ACID SODIUM MYRISTOYL GLUTAMATE PROPYLENE CARBONATE STEARIC ACID
ALPHA-ISOMETHYL IONONE DISODIUM EDTA TETRASODIUM EDTA HYDROGEN DIMETHICONE BENZYL BENZOATE MALVA SYLVESTRIS
(MALLOW) EXTRACT LINALOOL BHT BENZYL ALCOHOL LIMONENE AMYL CINNAMAL GERANIOL TOCOPHEROL [ MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES) CI 77891 (TITANIUM DIOXIDE)] (11594)

Package Labeling:

INGREDIENTS AND APPEARANCE

LINGERIE DE PEAU AQUA NUDE WATER-INFUSED PERFECTING FLUID INTENSE HYDRATION LONG-WEAR FOUNDATION WITH SUNSCREEN BROAD SPECTRUM SPF 20 06W VERY DEEP WARM 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-2016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	39.9 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	30.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DECYLOXAZOLIDINONE (UNII: 95K9FHM51V)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOSTEARIC ACID (UNII: X33R8U0062)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZYL BENZOATE (UNII: N863NB338G)
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)
GERANIOL (UNII: L837108USY)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-2016-1	1 in 1 BOX	05/13/2017
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49817-2016-3	1 in 1 BOX	05/13/2017
2		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	05/13/2017

Labeler - Guerlain (266623064)