TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT- octinoxate, titanium dioxide cream

TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT by

Drug Labeling and Warnings

TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GUERLAIN TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT

Active ingredients

Octinoxate 3.99%
Titanium Dioxide 4.38%

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.
  

Inactive ingredients

AQUA (WATER) - METHYL TRIMETHICONE - ALCOHOL - DIMETHICONE - ISODODECANE - PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE - POLYMETHYLSILSESQUIOXANE - ACRYLATES/DIMETHICONE COPOLYMER - DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER - GLYCERIN - ALUMINUM HYDROXIDE - STEARIC ACID - DISTEARDIMONIUM HECTORITE - PHENOXYETHANOL - GLYCERYL UNDECYL DIMETHICONE - SODIUM MYRISTOYL GLUTAMATE - HYDROXYETHYLCELLULOSE - SODIUM CHLORIDE -
PROPYLENE CARBONATE - PARFUM (FRAGRANCE) - CHLORELLA VULGARIS EXTRACT - DIAMOND POWDER - BENZYL SALICYLATE - LINALOOL - TROPAEOLUM MAJUS EXTRACT - BHT - ETHYLHEXYLGLYCERIN - TOCOPHEROL - [MAY CONTAIN: CI 77891 (TITANIUM DIOXIDE) - CI 77492, CI 77491, CI 77499 (IRON OXIDES)]  (08216)

Other information

• Protect this product from excessive heat and direct sun.
  

Question or comments?

In USA: 19 East, 57 th Street, New York, NY 10022

GUERLAIN TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT 30ml (

49817-0077-1)

INGREDIENTS AND APPEARANCE

TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT 
octinoxate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-0077
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	43.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
DIAMOND (UNII: 6GRV67N0U2)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
TROPAEOLUM MAJUS (UNII: 9G6ZOS4L87)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
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: 49817-0077-1	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/10/2014

Labeler - Guerlain (266623064)

Establishment
Name	Address	ID/FEI	Business Operations
Guerlain		266623064	manufacture(49817-0077)