LANCOME PARIS RENERGIE LIFT MAKEUP BROAD SPECTRUM SPF 26 SUNSCREEN- octinoxate liquid

Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, BPS60. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

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

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, getmedical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

●  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, cyclopentasiloxane, phenyl trimethicone, cyclohexasiloxane, butylene glycol, propanediol, cetyl PEG/PPG-10/1 dimethicone, pentylene glycol, polyglyceryl-4 isostearate, zea mays (corn) kernel extract, glycine soja (soybean) oil, copernicia cerifera (carnauba) wax, iris florentina root extract, cyhathea medullaris leaf extract; PEG-10 dimethicone, PEG-30 glyceryl stearate, PEG/PPG-18/18 dimethicone, ceramide NP, sorbitol, glycerin, glyceryl caprylate, dimethicone, caffeine, lecithin, sodium levulinate, silylate, cellulose gum, 2-oleamido-1,3-octadecanediol, perlite, aluminum hydroxide, guanosine, magnesium sulfate, cinnamic acid, alcohol denat., poloxamer 188, disodium EDTA, disodium stearoyl glutamate, hydrolyzed linseed extract, hydroxypalmitoyl sphinganine,caprylyl glycol, pentasodium ethylenediamine tetramethylene phosphonate, xanthan gum, levulinic acid, polycaprolactone, BHT, tocopherol, pentaerytrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, sodium benzoate, phenoxyethanol; may contain: titanium dioxide, bismuth oxychloride, 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 RENERGIE LIFT MAKEUP BROAD SPECTRUM SPF 26 SUNSCREEN 
octinoxate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-132
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CORN (UNII: 0N8672707O)
SOYBEAN OIL (UNII: 241ATL177A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD)
CYATHEA MEDULLARIS LEAF (UNII: G65ROR2RKA)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 GLYCERYL STEARATE (UNII: MW8WP96K3D)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CERAMIDE NP (UNII: 4370DF050B)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAFFEINE (UNII: 3G6A5W338E)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
9-OCTADECENAMIDE, N-(2-HYDROXY-1-(HYDROXYMETHYL)HEPTADECYL)-, (9Z)- (UNII: 30D478BUNR)
PERLITE (UNII: 0SG101ZGK9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
GUANOSINE (UNII: 12133JR80S)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CINNAMIC ACID (UNII: U14A832J8D)
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 188 (UNII: LQA7B6G8JG)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HYDROXYPALMITOYL SPHINGANINE (UNII: NR33W2353T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEXIDRONAM PENTASODIUM (UNII: 2ZYX2V82AD)
XANTHAN GUM (UNII: TTV12P4NEE)
LEVULINIC ACID (UNII: RYX5QG61EI)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TOCOPHEROL (UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
SORBIC ACID (UNII: X045WJ989B)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-132-01	1 in 1 CARTON	10/30/2019
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-132-02	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/30/2019
3	NDC: 49967-132-03	1 in 1 CARTON	10/30/2019
3		10 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	10/30/2019

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-132) , pack(49967-132)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-132)