LESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE/LIGHT COOL- titanium dioxide emulsion

LESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 by

Drug Labeling and Warnings

LESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 by is a Otc medication manufactured, distributed, or labeled by Guerlain. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 1.76%

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.
• 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) ● C9-12 ALKANE ● GLYCERIN ● PROPANEDIOL ● POLYGLYCERYL-6 POLYRICINOLEATE ● SILICA ● C15-19 ALKANE ● VP /EICOSENE COPOLYMER ● DICAPRYLYL CARBONATE ● POLYGLYCERYL-2 ISOSTEARATE ● COCO-CAPRYLATE/CAPRATE ● DISTEARDIMONIUM HECTORITE ● SORBITAN SESQUIISOSTEARATE ● PARFUM (FRAGRANCE) ● CAESALPINIA SPINOSA FRUIT EXTRACT ● ALPHA-GLUCAN OLIGOSACCHARIDE ● SODIUM MYRISTOYL GLUTAMATE ● STEARIC ACID ● SODIUM CITRATE ● XANTHAN GUM ● ALUMINA ● POLYHYDROXYSTEARIC ACID ● CELLULOSE ● POTASSIUM SORBATE ● KAPPAPHYCUS ALVAREZII EXTRACT ● POLYMNIA SONCHIFOLIA ROOT JUICE ● CITRIC ACID ● BUTYLENE GLYCOL ● ALUMINUM HYDROXIDE ● MALTODEXTRIN ● LACTOBACILLUS ● TOCOPHEROL ● THEOBROMA CACAO (COCOA) SEED EXTRACT ● [MAY CONTAIN : CI 77491, CI 77492, CI 77499 (IRON OXIDES) ● CI 77891 (TITANIUM DIOXIDE) ● CI 77947 (ZINC OXIDE)]

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.

L’ESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE/LIGHT COOL, 30mL (

49817-2045-1)

L’ESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 02C CLAIR ROSE/LIGHT COOL, 15mL (

49817-2045-3)

INGREDIENTS AND APPEARANCE

LESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20   02C CLAIR ROSE/LIGHT COOL
titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49817-2045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	17.6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C15-19 ALKANE (UNII: CI87N1IM01)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
SODIUM MYRISTOYL GLUTAMATE (UNII: AYU7QD893W)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
XANTHAN GUM (UNII: TTV12P4NEE)
ALUMINUM OXIDE (UNII: LMI26O6933)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA (UNII: D9108TZ9KG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49817-2045-1	1 in 1 BOX	03/10/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49817-2045-3	1 in 1 BOX	03/10/2019
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	03/10/2019

Labeler - Guerlain (266623064)