LANCOME PARIS RENERGIE LIFT MULTIACTION ULTRA FIRMING AND DARK SPOT CORRECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate and octocrylene lotion

Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Renergie Lift MultiAction Ultra Firming and Dark Spot Correcting Moisturizer Broad Spectrum SPF 30 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, Socoplan. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

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 of 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, silica, PEG-100 stearate, glyceryl stearate, glycolic acid, guanosine, cyathea medullaris leaf extract, t-butyl alcohol, dicaprylyl carbonate, mica, tocopherol, ascorbyl glycoside, sodium hydroxide, sodium hyaluronate, hydrolyzed linseed extract, sodium benzoate, sodium levulinate, stearic acid, phenoxyethanol, steareth-100, phenylethyl resorcinol, palmitic acid, ammonium polyacryloyldimethyl taurate, dimethicone/vinyl dimethicone crosspolymer, limonene, xanthan gum, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, benzyl alcohol, tin oxide, cinnamic acid, leontopodium alpinum extract, caprylyl glycol, myristic acid, geraniol, disodium EDTA, titanium dioxide, retinyl palmitate, citric acid, potassium sorbate, levulinic acid, glyceryl pacrylate, fragrance

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 MULTIACTION ULTRA FIRMING AND DARK SPOT CORRECTING MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-768
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GUANOSINE (UNII: 12133JR80S)
CYATHEA MEDULLARIS LEAF (UNII: G65ROR2RKA)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARETH-100 (UNII: 4OH5W9UM87)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
PALMITIC ACID (UNII: 2V16EO95H1)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STANNIC OXIDE (UNII: KM7N50LOS6)
CINNAMIC ACID (UNII: U14A832J8D)
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MYRISTIC ACID (UNII: 0I3V7S25AW)
GERANIOL (UNII: L837108USY)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LEVULINIC ACID (UNII: RYX5QG61EI)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-768-01	1 in 1 CARTON	09/01/2017
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-768-02	1 in 1 CARTON	09/01/2017
2		5 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-768-03	1.5 mL in 1 PACKET; Type 0: Not a Combination Product	09/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-768) , pack(49967-768)

Establishment
Name	Address	ID/FEI	Business Operations
Socoplan		276221405	pack(49967-768)