VISAGE ENVY INVISIBLE FACE GEL SPF50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Visage Envy Invisible Face Gel SPF50 by

Drug Labeling and Warnings

Visage Envy Invisible Face Gel SPF50 by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone, 3%

Homosalate, 15%

Octisalate, 5%

Octocrylene, 10%

Oxybenzone, 4%

PURPOSE

Purpose

sunscreen

INDICATIONS & USAGE

Uses  helps prevent sunburn if sued as directed with other sun

protection measures (see Directions),  decreases the risk of skin

cancer and early aging caused by the sun.

WARNINGS

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

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information  protect the product in this container

from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients isohexadecane, dimethicone bis-isobutyl

PEG-20 crosspolymer, cyclopentasiloxane, phenoxyethanol, fragrance,

tocopheryl acetate (vitamin E), plukenetia volubis seed oil tocopherol,

bisabolol, astaxanthin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VISAGE ENVY INVISIBLE FACE GEL SPF50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.54 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.51 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.02 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.01 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
ASTAXANTHIN (UNII: 8XPW32PR7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-005-50	1 in 1 BOX	05/05/2018	06/18/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/05/2018	06/18/2020

Labeler - Emilia Cosmetics Ltd (600076624)