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NDC 49817-2033-03 PLESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 17.6 mg/mL Details

PLESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 17.6 mg/mL

PLESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 is a TOPICAL EMULSION in the HUMAN OTC DRUG category. It is labeled and distributed by Guerlain. The primary component is TITANIUM DIOXIDE.

Product Information

NDC	49817-2033
Product ID	49817-2033_83f9f692-f868-d62f-e053-2991aa0a3a15
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	PLESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20
Proprietary Name Suffix	00N PORCELAINE/PORCELAIN
Non-Proprietary Name	TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	EMULSION
Route	TOPICAL
Active Ingredient Strength	17.6
Active Ingredient Units	mg/mL
Substance Name	TITANIUM DIOXIDE
Labeler Name	Guerlain
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 49817-2033-03 (49817203303)

Pricing Information	N/A
NDC Package Code	49817-2033-3
Billing NDC	49817203303
Package	1 BOTTLE in 1 BOX (49817-2033-3) / 15 mL in 1 BOTTLE
Marketing Start Date	2019-03-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 5c6751ac-e825-4fab-b31b-6eab0cb12db6 Details

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.

PL’ESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 00N PORCELAINE/PORCELAIN, 30mL (49817-2033-1)

L’ESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 00N PORCELAINE/PORCELAIN, 15mL (49817-2033-3)

INGREDIENTS AND APPEARANCE

PLESSENTIEL NATURAL GLOW FOUNDATION 16H WEAR WITH SUNSCREEN BROAD SPECTRUM SPF 20 00N PORCELAINE/PORCELAIN

titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49817-2033
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49817-2033-1	1 in 1 BOX	03/09/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:49817-2033-3	1 in 1 BOX	03/09/2019
2		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/09/2019

Labeler - Guerlain (266623064)

Revised: 3/2019

Document Id: 83f9f692-f868-d62f-e053-2991aa0a3a15

Set id: 5c6751ac-e825-4fab-b31b-6eab0cb12db6

Version: 1

Effective Time: 20190313