LANCOME PARIS UV EXPERT AQUAGEL DEFENSE 50 PLUS SUNSCREEN BROAD SPECTRUM SPF 50 PLUS PRIMER AND MOISTURIZER WITH ANTIOXIDANT VITAMIN E- avobenzone, homosalate, octisalate and octocrylene cream 
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.

----------

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 15%

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

Flammable until dry.

Do not use near fire, flame, or heat.

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 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, alcohol denat., styrene/acrylates copolymer, dimethicone, acrylates/dimethicone copolymer, tocopherol, dicaprylyl ether, sodium polyacrylate, sodium dodecylbenzenesulfonate, sodium benzoate, diethylhexyl syringylidenemalonate, phenoxyethanol, PEG-8 laurate, trisodium ethylenediamine disuccinate, menthyl lactate, pentylene glycol, mentha piperita (peppermint) extract, xanthan gum, propanediol, leontopodium alpinum flower/leaf extract, caprylyl glycol, caprylic/capric triglyceride, acrylates/c10-30 alkyl acrylate crosspolymer, moringa oleifera seed extract, rosa meichibon/delgramaue callus, disodium phosphate, butylene glycol, citric acid, potassium sorbate, glycerin, fragrance

Questions or comments?

1-800-LANCOME (1-800-526-2663) Monday - Friday (9 a.m. - 5 p.m. EST)

image of a carton

LANCOME PARIS UV EXPERT AQUAGEL DEFENSE 50 PLUS SUNSCREEN BROAD SPECTRUM SPF 50 PLUS PRIMER AND MOISTURIZER WITH ANTIOXIDANT VITAMIN E 
avobenzone, homosalate, octisalate and octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-614
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) HOMOSALATE150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE70 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PROPANEDIOL (UNII: 5965N8W85T)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-614-011 in 1 CARTON12/22/2022
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:49967-614-021 in 1 CARTON12/22/2022
210 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:49967-614-031 in 1 CARTON12/22/202212/30/2024
35 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC:49967-614-041 in 1 CARTON12/22/202212/30/2024
41 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/22/2022
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-614) , pack(49967-614)

Revised: 7/2023
 
L'Oreal USA Products Inc