LOREAL PARIS ANTISPOT REVITALIFT TRIPLE POWER INTENSIVE ANTIAGING DAY WITH PROXYLANE SPF 20- avobenzone, octisalate and octocrylene lotion 
L'Oreal USA Products Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

protect 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

image of a label

LOREAL PARIS ANTISPOT REVITALIFT TRIPLE POWER INTENSIVE ANTIAGING DAY WITH PROXYLANE SPF 20 
avobenzone, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-765
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-765-011 in 1 CARTON06/01/201604/11/2022
150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201604/11/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA, Inc.624244349manufacture(49967-765) , pack(49967-765)

Revised: 1/2023
Document Id: d2cd69e1-b0f6-4ae7-8b2e-de7554ab25b8
Set id: fb78ff07-e82e-4152-ac13-fffbf1d509f8
Version: 3
Effective Time: 20230129
 
L'Oreal USA Products Inc