Label: ADVANCED ANTI-WRINKLE THERAPY CICATRICURE- avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50066-121-01 - 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 January 14, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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Active ingredients Purpose
Avobenzone 3%........................................Sunscreen
Octinoxate 7.5%.......................................Sunscreen
Octisalate 5%...........................................Sunscreen
Octocrylene 2.7%.....................................Sunscreen
Oxybenzone 4%........................................Sunscreen - 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:50066-121 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:50066-121-01 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 - CGI Packaging, LLC (080691099) Establishment Name Address ID/FEI Business Operations CGI Packaging, LLC 080691099 manufacture(50066-121)
