Label: ADVANCED ANTI-WRINKLE THERAPY CICATRICURE- avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% cream
- NDC Code(s): 50066-021-01
- Packager: Genomma Lab
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 18, 2019
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
ADVANCED ANTI-WRINKLE THERAPY CICATRICURE
avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% creamProduct 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)
