LANCOME PARIS VISIONNAIRE BROAD SPECTRUM SPF 20 SUNSCREEN ADVANCED MULTI CORRECTING ALL SKIN TYPES- avobenzone, octisalate and octocrylene cream

Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types by

Drug Labeling and Warnings

Lancome Paris Visionnaire Broad Spectrum SPF 20 Sunscreen Advanced Multi Correcting All Skin Types by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 generously and evenly 15 minutes before sun exposure

● reapply at least every 2 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 of age: Ask a doctor

Other information

protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, dimethicone, PTFE, alcohol denat., isopropyl isostearate, behenyl alcohol, synthetic wax, octyldodecanol, C13-14 isoparaffin, yeast extract, tocopheryl acetate, tocopherol, hydrolyzed soy protein, sodium cocoyl glutamate, sodium benzoate, phenoxyethanol, acetyl trifluoromethylphenyl valylglycine, PEG-100 stearate, ethylhexylglycerin, polyacrylamide, calcium PCA, salicyloyl phytosphingosine, ammonium acryloyldimethyltaurate/steareth-25 methacrylate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dimethiconol, limonene, vinyl dimethicone/methicone silsesquioxane crosspolymer, panthenol, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, pentylene glycol, linalool, caprylyl glycol, capryloyl salicylic acid, carbomer, disodium stearoyl glutamate, disodium EDTA, cetyl alcohol, methyldihydrojasmonate, cetearyl alcohol, retinyl palmitate, cetearyl glucoside, potassium sorbate, citronellol, BHT, laureth-7, glycine soja (soybean) protein

Questions or comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS VISIONNAIRE BROAD SPECTRUM SPF 20 SUNSCREEN ADVANCED MULTI CORRECTING ALL SKIN TYPES 
avobenzone, octisalate and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-194
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
ALCOHOL (UNII: 3K9958V90M)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DOCOSANOL (UNII: 9G1OE216XY)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
OCTYLDODECANOL (UNII: 461N1O614Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ACETYL TRIFLUOROMETHYLPHENYL VALYLGLYCINE, DL- (UNII: 95SP8380V9)
PEG-100 STEARATE (UNII: YD01N1999R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
CALCIUM PIDOLATE (UNII: 7Y2LVU5EKK)
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
PANTHENOL (UNII: WV9CM0O67Z)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CETYL ALCOHOL (UNII: 936JST6JCN)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
LAURETH-7 (UNII: Z95S6G8201)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-194-01	1 in 1 CARTON	05/01/2017
1		50 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 49967-194-02	1 in 1 CARTON	05/01/2017
2		5 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-194-04	1 in 1 CARTON	12/10/2018
3		15 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 49967-194-03	2 g in 1 PACKET; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-194) , pack(49967-194)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-194)

Establishment
Name	Address	ID/FEI	Business Operations
L'Oreal USA, Inc.		185931458	manufacture(49967-194)