NDC Code(s) : 16047-0023-1
Packager : Sesderma USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

REPASKIN FACIAL SUNSCREEN BROAD-SPECTRUM SPF 30 50mlOCTOCRYLENE, OXYBENZONE, OCTISALATE, OCTINOXATE, AVOBENZONE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16047-0023
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE40 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE30 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE30 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE30 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ALLANTOIN(UNII: 344S277G0Z)
ALUMINUM OXIDE(UNII: LMI26O6933)
ALUMINUM STEARATE(UNII: U6XF9NP8HM)
ARABIDOPSIS THALIANA(UNII: AI3L60HQ81)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
ISOCETETH-10(UNII: 1K92T9919H)
ISODECETH-6(UNII: 278Z9G87XH)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
METHYLPARABEN(UNII: A2I8C7HI9T)
OLETH-10(UNII: JD797EF70J)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MILK THISTLE(UNII: U946SH95EE)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16047-0023-11 in 1 CARTON
150 mL in 1 BOTTLE 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 06/15/2015

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