VISAGE ENVY FACIAL MOISTURIZING SPF30- avobenzone, homosalate, octisalate, octocrylene lotion 
Emilia Cosmetics Ltd

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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Visage Envy Facial Moisturizing SPF30

Active ingredients

Avobenzone, 2.1%

Homosalate, 4.0%

Octisalate, 4.0%

Octocrylene, 2.0%

Purpose

Sunscreen

Uses  •helps prevent sunburn  •if used as directed

with other sun protection measures (see Directions),

decreases the risk of skin cancer and other 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

•apply liberally 15 minutes before sun exposure •reapply at least every

2 hours •use water resistant sunscreen if swimming or sweating •children

under 6 months of age: ask a doctor.

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 prtection measures including:

•limit time in the sun, especially from 10 am. - 2 p.m.

•wear long-sleeved shirts, pants, hats and sunglasses

Other information •protect the product in this container

from excessive heat and direct sun.

Inactive ingredients Water, Dimethicone, Trisiloxanane, Isononyl Isononanoate, Cetyl Alcohol,

Glycerin, Steareth-21, Nylon-12, Silica, Stearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Dimethicone Crosspolymer, Xanthan Gum,

Tocopheryl Acetate (Vitamin E), Polysorbate 20,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Disodium EDTA, Sodium Hydroxide, BHT, Hyaluronic Acid

image description

VISAGE ENVY FACIAL MOISTURIZING SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.86 g  in 236.59 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.55 g  in 236.59 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.55 g  in 236.59 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.77 g  in 236.59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARETH-21 (UNII: 53J3F32P58)  
NYLON-12 (UNII: 446U8J075B)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
XANTHAN GUM (UNII: TTV12P4NEE)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-018-301 in 1 BOX05/05/201806/30/2022
188 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/05/201806/30/2022
Labeler - Emilia Cosmetics Ltd (600076624)
Establishment
NameAddressID/FEIBusiness Operations
Emilia Cosmetics Ltd600076624manufacture(43219-018)

Revised: 6/2023
 
Emilia Cosmetics Ltd