LOREAL PARIS ANTI-SPOT REVITALIFT TRIPLE POWER INTENSIVE ANTI-AGING DAY WITH PRO-XYLANE SPF 20- avobenzone, octisalate and octocrylene lotion

LOREAL PARIS ANTISPOT REVITALIFT TRIPLE POWER INTENSIVE ANTIAGING DAY WITH PROXYLANE SPF 20 by

Drug Labeling and Warnings

LOREAL PARIS ANTISPOT REVITALIFT TRIPLE POWER INTENSIVE ANTIAGING DAY WITH PROXYLANE SPF 20 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, L'Oreal USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 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, get medical 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

• pretect the product in this container from excessive heat and direct sun

Inactive ingredients

water, glycerin, silica, dimethicone, PEG-100 stearate, glyceryl stearate, hydroxyproyl tetrahydropyrantriol, octyldodecanol, ammonium polyacryloyldimethyl taurate, benzyl alcohol, bisabolol, capryloyl salicylic acid, caprylyl glycol, citronellol, dicaprylyl carbonate, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, farnesol, fragrance, isoeugenol, limonene, linalool, palmitic acid, phenoxyethanol, phenylethyl resorcinol, propylene glycol, sodium hyaluronate, sodium hydroxide, steareth-100, stearic acid, tocopherol, xanthan gum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LOREAL PARIS ANTI-SPOT REVITALIFT TRIPLE POWER INTENSIVE ANTI-AGING DAY WITH PRO-XYLANE SPF 20 
avobenzone, octisalate and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-765
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)
OCTYLDODECANOL (UNII: 461N1O614Y)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FARNESOL (UNII: EB41QIU6JL)
ISOEUGENOL (UNII: 5M0MWY797U)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
PALMITIC ACID (UNII: 2V16EO95H1)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARETH-100 (UNII: 4OH5W9UM87)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-765-01	1 in 1 CARTON	06/01/2016
1		50 mL in 1 BOTTLE, DISPENSING; 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	06/01/2016

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
L'OREAL USA, INC.		624244349	manufacture(49967-765) , pack(49967-765)