GUERLAIN TERRACOTTA JOLI TEINT BEAUTIFYING FOUNDATION WITH SUNSCREEN SUN-KISSED, HEALTHY GLOW BROAD SPECTRUM SPF 20 LIGHT - octinoxate and titanium dioxide cream
Guerlain S.A.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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, 57th 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)

Light Box Label

GUERLAIN 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 LABEL	Item Code (Source)	NDC:49817-0077
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (OCTINOXATE)	OCTINOXATE	39.9 mg in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE)	TITANIUM DIOXIDE	43.8 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
METHYL TRIMETHICONE
ALCOHOL
DIMETHICONE
ISODODECANE
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
GLYCERIN
ALUMINUM HYDROXIDE
STEARIC ACID
DISTEARDIMONIUM HECTORITE
PHENOXYETHANOL
SODIUM MYRISTOYL GLUTAMATE
SODIUM CHLORIDE
PROPYLENE CARBONATE
CHLORELLA VULGARIS
DIAMOND
BENZYL SALICYLATE
LINALOOL, (+/-)-
TROPAEOLUM MAJUS
BUTYLATED HYDROXYTOLUENE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
FERROSOFERRIC OXIDE

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49817-0077-1	30 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/28/2013

Labeler - Guerlain S.A. (395158322)

Name	Address	ID/FEI	Business Operations
Establishment
Guerlain S.A.		395158322	manufacture(49817-0077)

Revised: 11/2013

Document Id: 16b77009-0cb9-4f18-b870-7268c80b8fe7

Set id: 326ee6a0-5325-4425-b955-9a34374120df

Version: 1

Effective Time: 20131128

Guerlain S.A.