VISAGE ENVY REMODELING DAY CREAM SPF15- avobenzone, octocrylene cream

Visage Envy Remodeling Day Cream SPF15 by

Drug Labeling and Warnings

Visage Envy Remodeling Day Cream SPF15 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, 3.0%

Octocrylene, 10.0%

PURPOSE

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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 Water, Cyclopentasiloxane, Dimethicone Crosspolymer, Glycerin, Isohexadecane,

Behenyl Alcohol, Glyceryl Stearate, Glyceryl Stearate Citrate,

Disodium Ethylene Dicocamide PEG-15 Disulfate,

Butylene Glycol, Carbomer, Polysorbate 20, Palmitoyl Tripeptide-1,

Palmitoyl Tetrapeptide-7, Niacinamide, Polyacrylamide, C13-14 Isoparaffin,

Laureth-7, Silica, Stearyl Alcohol, Phenoxyethanol, Ethylhexylglycerin,

Tocopheryl Acetate (Vitamin E), Fragrance, Xanthan Gum,

Plukenetia Volubilis Seed Oil, Tocopherol, Panthenol (Pro-Vitamin B5),

Disodium EDTA, Bisabolol, Lactic Acid, Hyaluronic Acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VISAGE ENVY REMODELING DAY CREAM SPF15 
avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.51 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.03 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
DOCOSANOL (UNII: 9G1OE216XY)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
NIACINAMIDE (UNII: 25X51I8RD4)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
LEVOMENOL (UNII: 24WE03BX2T)
LACTIC ACID (UNII: 33X04XA5AT)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-020-15	1 in 1 BOX	05/05/2018	06/10/2020
1		50 mL in 1 JAR; 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	06/10/2020

Labeler - Emilia Cosmetics Ltd (600076624)