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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients Purpose

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

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

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

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

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

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. 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

image description

ADVANCED ANTI-WRINKLE THERAPY  CICATRICURE
avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-121-011 in 1 CARTON01/21/2019
142 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/21/2019
Labeler - Genomma Lab (832323534)
Registrant - CGI Packaging, LLC (080691099)
Establishment
NameAddressID/FEIBusiness Operations
CGI Packaging, LLC080691099manufacture(50066-121)

Revised: 1/2019
Document Id: 7f962f4d-4050-735a-e053-2a91aa0af65c
Set id: 7f95544e-c6b8-cd1a-e053-2991aa0ac867
Version: 2
Effective Time: 20190114
 
Genomma Lab