The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab for the product Advanced Anti-wrinkle Therapy (NDC 50066-121). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients purpose, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Avobenzone 3%........................................Sunscreen
Octinoxate 7.5%.......................................Sunscreen
Octisalate 5%...........................................Sunscreen
Octocrylene 2.7%.....................................Sunscreen
Oxybenzone 4%........................................Sunscreen
Sunscreen
• 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
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
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
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
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