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Skin Activator Lip Refiner SPF 15

Dosage form: cream
Ingredients: Octinoxate 0.0661g in 1mL, Octisalate 0.0472g in 1mL, Avobenzone 0.0142g in 1mL
Labeler: Cosmint Spa.
NDC Code: 63509-002

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 Facts

ACTIVE INGREDIENTS
Octinoxate (7%)
Octisalate (5%)
Avobenzone (1.5%)

DIRECTIONS
Smooth onto lips daily.
Apply prior to sun exposure

WARNINGS
For external use only.

Keep out of reach of children.
Use on children under 2 years of age only with the advice of physician.

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Discontinue use if signs of irritation or rush occurs. If irritation or rash persist, consult a doctor.

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)





SKIN ACTIVATOR  LIP REFINER SPF 15
octinoxate, octisalate and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63509-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (Octinoxate) Octinoxate0.0661 g  in 1 mL
Octisalate (Octisalate) Octisalate0.0472 g  in 1 mL
Avobenzone (Avobenzone) Avobenzone0.0142 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
ISOPROPYL ISOSTEARATE 
Yellow wax 
Diisopropyl Dilinoleate 
Shea butter 
Dimethicone 
Cetostearyl Alcohol 
Polyoxyl 20 Cetostearyl Ether 
Sodium Pyrrolidone Carboxylate 
Squalane 
Dipalmitoyl hydroxyproline 
Glucosamine hydrochloride 
Laminaria digitata 
Yeast 
Urea  
Ethylhexyl palmitate 
Tribehenin 
Sorbitan isostearate 
Palmitoyl oligopeptide 
Alpha-Tocopherol Acetate 
Tetrahexyldecyl ascorbate 
Levomenol 
Green Tea Leaf 
Xanthan gum 
Glyceryl Monostearate 
PEG-100 Stearate 
Peppermint oil 
Edetate Sodium 
Packaging
#Item CodePackage Description
1NDC:63509-002-011 TUBE (TUBE) in 1 CARTON
115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/21/2011
Labeler - Cosmint Spa. (444392468)
Establishment
NameAddressID/FEIOperations
Cosmint Spa.444392468manufacture

Revised: 11/2011
 
Cosmint Spa.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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