LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE LIGHT COOL- octinoxate, titanium dioxide emulsion

LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE LIGHT COOL by

Drug Labeling and Warnings

LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE LIGHT COOL 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%

Titanium Dioxide 3.16%

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 10a.m.-2p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive ingredients

AQUA(WATER), METHYL TRIMETHICONE, DIMETHICONE, ALCOHOL, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, SILICA, ACRYLATES/DIMETHICONE COPOLYMER, ACRYLATES COPOLYMER, ALUMINUM HYDROXIDE, BUTYLENE GLYCOL DICAPRYLATE/DICA- PRATE, STEARIC ACID, SORBITAN SESQUIOLEATE, PHENOXYETHANOL, ALUMINA, SODIUM MYRISTOYL GLUTAMATE, HYDROXYETHYL CELLULOSE, LECITHIN, TETRASODIUM EDTA, PARFUM (FRAGRANCE), BUTYLPHENYL METHYLPROPIONAL, SERICIN, LINALOOL, BHT, CITRONELLOL, ALPHA-ISOMETHYL IONONE, HYDROLYZED LINSEED EXTRACT, CITRIC ACID, POTASSIUM SORBATE, [MAY CONTAIN:MICA, CI77891(TITANIUM DIOXIDE), CI 77491, CI 77492, CI77499 (IRON OXIDES)]

Other information

• Protect this product from excessive heat and direct sun.

Questions or comments?

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

Package Labeling:

INGREDIENTS AND APPEARANCE

LINGERIE DE PEAU NATURAL PERFECTION FOUNDATION SKIN-FUSION TEXTURE WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE LIGHT COOL 
octinoxate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-2002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
DIMETHICONE (UNII: 92RU3N3Y1O)
ALCOHOL (UNII: 3K9958V90M)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
STEARIC ACID (UNII: 4ELV7Z65AP)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALUMINUM OXIDE (UNII: LMI26O6933)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
EDETATE SODIUM (UNII: MP1J8420LU)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-2002-1	1 in 1 BOX	04/13/2016
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49817-2002-3	1 in 1 BOX	04/13/2016
2		15 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	04/13/2016

Labeler - Guerlain (266623064)