LANCOME PARIS TEINT IDOLE ULTRA CARE AND GLOW SKINCARE FOUNDATION BROAD SPECTRUM SPF 27 SUNSCREEN- ensulizole liquid

Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 Sunscreen by is a Otc medication manufactured, distributed, or labeled by SICOS ET CIE, SOCOPLAN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Ensulizole 3.6%

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

Flammable until dry.

Do not use near fire, flame, or heat.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with wate 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:

●  shake well

●  apply liberally 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

dimethicone, water, isododecane, alcohol denat., trimethylsiloxysilicate, propylene glycol, glycerin, PEG/PPG-18/18 dimethicone, silica, synthetic fluorphlogopite, polysilicone-11, rosa gallica flower extract, moringa oleifera seed extract, polymnia sonchifolia root juice, sorbitol, mandelic acid, PEG-10 dimethicone, alpha-glucan oligosaccharide. sodium chloride, sodium hyaluronate, sodium hydroxide, silica silylate, cellulose acetate butyrate, aluminum hydroxide, ammonium polyacryloyldimethyl taurate, disodium phosphate, disodium stearoyl glutamate, hydroxyethylpiperazine ethane sulfonic acid, caprylyl glycol, citric acid, lactobacillus, maltodextrin, polyphosphorylcholine glycol acrylate, polyvinyl alcohol, butylene glycol, tocopherol, phenoxyethanol, fragrance, linalool, geraniol, limonene, citral, citronellol, benzyl alcohol; may contain: titanium dioxide, iron oxides

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 TEINT IDOLE ULTRA CARE AND GLOW SKINCARE FOUNDATION BROAD SPECTRUM SPF 27 SUNSCREEN 
ensulizole liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51150-676
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	36 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
ROSA GALLICA FLOWER (UNII: X8W61WUV70)
SORBITOL (UNII: 506T60A25R)
MANDELIC ACID (UNII: NH496X0UJX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACID (UNII: RWW266YE9I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
GERANIOL (UNII: L837108USY)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CITRAL (UNII: T7EU0O9VPP)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51150-676-01	1 in 1 CARTON	05/01/2022	05/01/2022
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51150-676-02	1 mL in 1 PACKET; Type 0: Not a Combination Product	05/01/2022	12/08/2026
3	NDC: 51150-676-03	1.6 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/01/2022	01/19/2026
4	NDC: 51150-676-04	1 in 1 CARTON	05/01/2022	05/16/2027
4		30 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 Drug	M020	05/01/2022	05/16/2027

Labeler - SICOS ET CIE (276993581)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(51150-676) , pack(51150-676)

Establishment
Name	Address	ID/FEI	Business Operations
SOCOPLAN		276221405	pack(51150-676)