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, Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3%., Octinoxate 7.5%, Octisalate 5%,Octocrylene 2.7%,Oxybenzone 4%.

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 right away.

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: 50066-021
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: 50066-021-01	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 - Derma Care Research Labs, LLC (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs, LLC		116817470	manufacture(50066-021)