ADVANCED ANTI-WRINKLE THERAPY CICATRICURE- avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% cream

Advanced Anti-Wrinkle Therapy by

Drug Labeling and Warnings

Advanced Anti-Wrinkle Therapy by is a Otc medication manufactured, distributed, or labeled by Genomma Lab, CGI Packaging, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients Purpose

Avobenzone 3%........................................Sunscreen

Octinoxate 7.5%.......................................Sunscreen

Octisalate 5%...........................................Sunscreen

Octocrylene 2.7%.....................................Sunscreen

Oxybenzone 4%........................................Sunscreen

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

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 immediately

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 factor of 15 or

higher and other skin protection measures including:

limit time in the sun, especially from 10am to 2pm

wear long-sleeved shirts, pants, hats and sunglasses

children under 6 months of age: ask a doctor

Inactive ingredients

Water

Glycerin

Dimethicone

Ethylhexyl Methoxycrylene

Neopentyl Glycol Diheptanoate

Glyceryl Stearate

Butylene Glycol

Isostearyl Neopentanoate

PPG-2 Isoceteth-20 Acetate

Polymethyl Methacrylate

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer

Bakuchiol

Retinyl Palmitate

Tocopheryl Acetate

Bisabolol

Cetearyl Alcohol

Sorbitan Oleate

Retinol

Hydroxypinacolone Retinoate

Myristoyl Nanapeptide-3

Palmitoyl Oligopeptide

Palmitoyl Tetrapeptide-7

Tocopherol

Sodium Ascorbate

Sodium Hyaluronate

Caprylic/Capric Triglyceride

Dimethicone Crosspolymer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Behenyl Alcohol

Sodium Lactate

Ethylhexylglycerin

Isohexadecane

Polysorbate 80

Polysorbate 20

Dimethyl Isosorbide

Xanthan Gum

Carbomer

Disodium EDTA

Sodium Hydroxide

Pentylene Glycol

Chlorphenesin

Phenoxyethanol

Caprylyl Glycol

Citric Acid

Potassium Sorbate

Fragrance

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ADVANCED ANTI-WRINKLE THERAPY  CICATRICURE
avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
BAKUCHIOL (UNII: OT12HJU3AR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LEVOMENOL (UNII: 24WE03BX2T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
RETINOL (UNII: G2SH0XKK91)
HYDROXYPINACOLONE RETINOATE (UNII: NJ3V2F02E1)
MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM ASCORBATE (UNII: S033EH8359)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DOCOSANOL (UNII: 9G1OE216XY)
SODIUM LACTATE (UNII: TU7HW0W0QT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CHLORPHENESIN (UNII: I670DAL4SZ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-121-01	1 in 1 CARTON	01/21/2019
1		42 g 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 not final	part352	01/21/2019

Labeler - Genomma Lab (832323534)

Registrant - CGI Packaging, LLC (080691099)

Establishment
Name	Address	ID/FEI	Business Operations
CGI Packaging, LLC		080691099	manufacture(50066-121)