Otc - Active Ingredient
ACTIVE INGREDIENTS
Octinoxate (7%)
Octisalate (5%)
Avobenzone (1.5%)
Skin Activator
FDA Label NDC 63509-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmint Spa. for the product Skin Activator (NDC 63509-002). 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 otc - active ingredient, dosage & administration, warnings, otc - keep out of reach of children, otc - when using, otc - stop use, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
DIRECTIONS
Smooth onto lips daily.
Apply prior to sun exposure
Warnings
WARNINGS
For external use only.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Use on children under 2 years of age only with the advice of physician.
Otc - When Using
Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Discontinue use if signs of irritation or rush occurs. If irritation or rash persist, consult a doctor.
Inactive Ingredient
INACTIVE INGREDIENTS
Water
Glycerin
Isopropyl isostearate
Beeswax (cera alba)
Diisopropyl dimer dilinoleate
Butyrospermum parkii (shea) butter
Dimethicone
Cetearyl alcohol
Ceteareth 20
Sodium pca
Squalane
Dipalmitoyl hydroxyproline
Glucosamine hydrochloride
Algae extract
Yeast extract
Urea
Ethylhexyl palmitate
Tribehenin
Sorbitan isostearate
Palmitoyl oligopeptide
Tocopherol acetate
Tetrahexyldecyl ascorbate
Bisabolol
Camellia sinensis leaf extract
Xanthan gum
Glyceryl stearate
Peg 100 stearate
Mentha piperita (peppermint) oil
Tetrasodium edta
Fragrance (parfum)
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