LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 4 MEDIUM- octinoxate, oxybenzone, titanium dioxide emulsion

LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 4 MEDIUM by

Drug Labeling and Warnings

LINGERIE DE PEAU BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 4 MEDIUM 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 3.74%

Oxybenzone 1.00% 

Titanium Dioxide 3.55%

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, regullarly 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.

Inactive Ingredients:

AQUA (WATER) METHYL TRIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE C12-15 ALKYL BENZOATE GLYCERIN ISODODECANE CETYL PEG/PPG-10/1 DIMETHICONE BUTYLENE GLYCOL NYLON 6/12 ALCOHOL BETAINE MAGNESIUM SULFATE PHENOXYETHANOL DISTEARDIMONIUM HECTORITE ALUMINUM STEARATE SORBITAN SESQUIOLEATE POLYHYDROXYSTEARIC ACID SODIUM MYRISTOYL GLUTAMATE CAPRYLYL GLYCOL PARFUM (FRAGRANCE) ALUMINA PROPYLENE CARBONATE ALUMINUM HYDROXIDE ACRYLATES / DIMETHICONE COPOLYMER BUTYLPHENYL METHYLPROPIONAL HYALURONIC ACID TOCOPHERYL ACETATE LINALOOL CITRONELLOL BHT ALPHA-ISOMETHYL IONONE BENZYL BENZOATE GERANIOL SERICIN LIMONENE HYDROLYZED LINSEED EXTRACT PENTAERYTHRITYL TETRADI- T-BUTYL HYDROXYHYDROCINNAMATE CITRIC ACID POTASSIUM SORBATE [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) CI 77492, CI 77491, CI 77499 (IRON OXIDES)] (11566)

Other information

• Protect this product from excessive heat and direct sun.

Question 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 BB INVISIBLE SKIN-FUSION MULTI-PERFECTING MAKEUP WITH SUNSCREEN BROAD SPECTRUM SPF 30 BB 4 MEDIUM 
octinoxate, oxybenzone, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-2030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	37.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	35.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
BETAINE (UNII: 3SCV180C9W)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM OXIDE (UNII: LMI26O6933)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
HYALURONIC ACID (UNII: S270N0TRQY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BENZYL BENZOATE (UNII: N863NB338G)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-2030-1	1 in 1 BOX	09/08/2017
1		40 mL in 1 TUBE; 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	09/08/2017

Labeler - Guerlain (266623064)