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

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:50066-021
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:50066-021-011 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 - Derma Care Research Labs, LLC (116817470)
Establishment
NameAddressID/FEIBusiness Operations
Derma Care Research Labs, LLC116817470manufacture(50066-021)

Revised: 2/2019
Document Id: 8153c706-d1be-6c42-e053-2991aa0afda4
Set id: 8153c706-d1bd-6c42-e053-2991aa0afda4
Version: 1
Effective Time: 20190218
 
Genomma Lab