LANCOME PARIS TEINT IDOLE ULTRA WEAR BREATHABLE COVERAGE FOUNDATION RENO BROAD SPECTRUM SPF 25 SUNSCREEN- octinoxate and titanium dioxide liquid

Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS60, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 6.7%

Titanium dioxide 11.5%

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

water, dimethicone, isododecane, alcohol denat., trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, perlite, synthetic fluorphlogopite, moringa oleifera seed extract, polymnia sonchifolia root juice, calcium aluminum borosilicate, glycerin, dipentaerythrityl tetrahydroxystearate/tetraisostearate, alpha-glucan oligosaccharide, sodium hyaluronate, silica, silica silylate, HDI/trimethylol hexyllactone crosspolymer, cellulose, aluminum hydroxide, magnesium sulfate, nylon-12, disodium phosphate, disodium stearoyl glutamate, isopropyl lauroyl sarcosinate, hydrogen dimethicone, citric acid, diisopropyl sebacate, bis-PEG/PPG-14/14 dimethicone, lactobacillus, maltodextrin, disteardimonium hectorite, BHT, tocopherol, phenoxyethanol; may contain: titanium dioxide, iron oxides, chromium oxide greens

Questions or comments?

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LANCOME PARIS TEINT IDOLE ULTRA WEAR BREATHABLE COVERAGE FOUNDATION RENO BROAD SPECTRUM SPF 25 SUNSCREEN 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	67 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	115 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISODODECANE (UNII: A8289P68Y2)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PERLITE (UNII: 0SG101ZGK9)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
MORINGA OLEIFERA SEED (UNII: TIX5482832)
SMALLANTHUS SONCHIFOLIUS ROOT JUICE (UNII: M9S7HX36CT)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
GLYCERIN (UNII: PDC6A3C0OX)
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
NYLON-12 (UNII: 446U8J075B)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)
EMMENTAL LACTOBACILLUS (UNII: B253LSV04X)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-303-01	1 in 1 CARTON	12/12/2022
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-303-02	100 mL in 1 TUBE; Type 0: Not a Combination Product	12/12/2022
3	NDC: 49967-303-03	1 mL in 1 PACKET; Type 0: Not a Combination Product	12/12/2022	01/22/2027
4	NDC: 49967-303-04	0.4 mL in 1 PACKAGE; Type 0: Not a Combination Product	12/12/2022	12/28/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/12/2022

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-303) , pack(49967-303)

Establishment
Name	Address	ID/FEI	Business Operations
BPS60		272259304	pack(49967-303)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-303)