ADVANCED ANTI-WRINKLE THERAPY CICATRICURE- avobenxone 3.00 octinoxate 7.50 octisalate 5.00 octocrylene 2.70 oxybenzone 4.00 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, Product Quest Mfg.. 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

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 3.00 octinoxate 7.50 octisalate 5.00 octocrylene 2.70 oxybenzone 4.00 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50066-033
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 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	7.5 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2.7 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexyl Methoxycrylene (UNII: S3KFG6Q5X8)
Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50066-033-02	1 in 1 CARTON	06/09/2016
1		44 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 not final	part352	06/09/2016

Labeler - Genomma Lab (832323534)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(50066-033)