ADVANCED ANTI-WRINKLE THERAPY CICATRICURE- avobenxone 3.00 octinoxate 7.50 octisalate 5.00 octocrylene 2.70 oxybenzone 4.00 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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Drug Facts

Active ingredients                                   Purpose

Avobenzone 3%........................................Sunscreen
Octinoxate 7.5%.......................................Sunscreen
Octisalate 5%...........................................Sunscreen
Octocrylene 2.7%.....................................Sunscreen
Oxybenzone 4%........................................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 3.00 octinoxate 7.50 octisalate 5.00 octocrylene 2.70 oxybenzone 4.00 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.7 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50066-033-021 in 1 CARTON06/09/201609/21/2022
144 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/09/201609/21/2022
Labeler - Genomma Lab (832323534)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(50066-033)

Revised: 9/2022
Document Id: 0382fe1c-fd8c-4d14-aaea-4cf80dfbbb1e
Set id: 490bc3d8-9684-485f-a163-e80f132e62ab
Version: 3
Effective Time: 20220922
 
Genomma Lab