LOREAL PARIS WRINKLE EXPERT AGE DEFENSE 55 PLUS BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, and octocrylene lotion 
L'Oreal USA Products Inc

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Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 5%

Octisalate 5%

Octocrylene 7.2%

Purpose

Sunscreen

Uses

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, stearic acid, phenoxyethanol, palmitic acid, ammonium polyacryloyldimethyl taurate, dicaprylyl carbonate, steareth-100, phenylethyl resorcinol, capryloyl salicylic acid, caprylyl glycol, xanthan gum, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, fragrance, tocopherol, calcium PCA, sodium hyaluronate, ascorbyl glucoside, myristic acid, sodium hydroxide

image of a label

image of a label
LOREAL PARIS WRINKLE EXPERT AGE DEFENSE 55 PLUS BROAD SPECTRUM SPF 30 SUNSCREEN 
avobenzone, homosalate, octisalate, and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-291
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate50 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene72 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)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PALMITIC ACID (UNII: 2V16EO95H1)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
STEARETH-100 (UNII: 4OH5W9UM87)  
PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CALCIUM PIDOLATE (UNII: 7Y2LVU5EKK)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-291-011 in 1 CARTON05/21/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/21/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products Inc624244349manufacture(49967-291)

Revised: 12/2023
Document Id: fb7ef028-f19e-4ab5-b517-e94d464d391f
Set id: fa0b25a9-648a-4c7e-95c0-b7cb3dd525dd
Version: 2
Effective Time: 20231229
 
L'Oreal USA Products Inc