Drug Facts

SKIN ACTIVATOR LIP REFINER SPF 15- octinoxate, octisalate and avobenzone cream
Cosmint Spa.

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.

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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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63509-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.0661 g in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.0472 g in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.0142 g in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
Yellow wax (UNII: 2ZA36H0S2V)
Diisopropyl Dilinoleate (UNII: 5323S7S2LR)
Shea butter (UNII: K49155WL9Y)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)
Squalane (UNII: GW89575KF9)
Dipalmitoyl hydroxyproline (UNII: E6AHA53N1H)
Glucosamine hydrochloride (UNII: 750W5330FY)
Laminaria digitata (UNII: 15E7C67EE8)
Yeast (UNII: 3NY3SM6B8U)
Urea (UNII: 8W8T17847W)
Ethylhexyl palmitate (UNII: 2865993309)
Tribehenin (UNII: 8OC9U7TQZ0)
Sorbitan isostearate (UNII: 01S2G2C1E4)
Palmitoyl oligopeptide (UNII: HO4ZT5S86C)
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
Levomenol (UNII: 24WE03BX2T)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Xanthan gum (UNII: TTV12P4NEE)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Peppermint oil (UNII: AV092KU4JH)
Edetate Sodium (UNII: MP1J8420LU)

#	Item Code	Package Description
Packaging
1	NDC:63509-002-01	1 in 1 CARTON
1		15 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	10/21/2011

Labeler - Cosmint Spa. (444392468)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmint Spa.		444392468	manufacture