LANCOME PARIS RENERGIE LIFT MAKEUP BROAD SPECTRUM SPF 20 SUNSCREEN- octinoxate and titanium dioxide liquid

Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 20 Sunscreen by

Drug Labeling and Warnings

Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 20 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, SICOS ET CIE, Laboratoires Biocosm SARL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Titanium dioxide 3.1%

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, cetyl PEG/PPG-10/1 dimethicone, pentylene glycol, polyglyceryl-4 isostearate, zea mays (corn) kernel extract, PEG-30 glyceryl stearate, PEG/PPG-18/18 dimethicone, ceramide 3, glycine soja (soybean) oil, copernicia cerifera (carnauba) wax, caffeine, cellulose gum, 2-oleamido-1,3-octadecanediol, aluminum hydroxide, magnesium sulfate alcohol denat., disodium stearoyl glutamate, hydroxypalmitoyl sphinganine, polycaprolactone, acrylates copolymer, acrylonitrile/methyl methacrylate/vinylidene chloride copolymer, tocopherol, methylparaben, phenoxyethanol, butylparaben; 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 20 SUNSCREEN 
octinoxate and titanium dioxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-661
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	31 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)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CORN (UNII: 0N8672707O)
PEG-30 GLYCERYL STEARATE (UNII: MW8WP96K3D)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
CERAMIDE 3 (UNII: 4370DF050B)
SOYBEAN OIL (UNII: 241ATL177A)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CAFFEINE (UNII: 3G6A5W338E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
9-OCTADECENAMIDE, N-(2-HYDROXY-1-(HYDROXYMETHYL)HEPTADECYL)-, (9Z)- (UNII: 30D478BUNR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
ALCOHOL (UNII: 3K9958V90M)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)
HYDROXYPALMITOYL SPHINGANINE (UNII: NR33W2353T)
TOCOPHEROL (UNII: R0ZB2556P8)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-661-01	1 in 1 CARTON	01/01/2015
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49967-661-02	110 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015
3	NDC: 49967-661-03	1 in 1 CARTON	01/01/2015
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	01/01/2015

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
SICOS ET CIE		276993581	manufacture(49967-661) , pack(49967-661)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Biocosm SARL		288479491	pack(49967-661)