NDC Code(s) : 16047-0026-1
Packager : Sesderma USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

REPASKIN BODY BROAD-SPECTRUM SPF 50OCTOCRYLENE, TITANIUM DIOXIDE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16047-0026
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE70 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE20 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)
OXYBENZONE(UNII: 95OOS7VE0Y)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
AVOBENZONE(UNII: G63QQF2NOX)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN(UNII: E4F12ROE70)
CAMELLIA OLEIFERA LEAF(UNII: 5077EL0C60)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETEARYL ETHYLHEXANOATE(UNII: 9M64UO4C25)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
OCTINOXATE(UNII: 4Y5P7MUD51)
OCTISALATE(UNII: 4X49Y0596W)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYDROLYZED JOJOBA ESTERS (ACID FORM)(UNII: UDR641JW8W)
ISODECETH-6(UNII: 278Z9G87XH)
LAURETH-7(UNII: Z95S6G8201)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
METHYLPARABEN(UNII: A2I8C7HI9T)
OLETH-10(UNII: JD797EF70J)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE(UNII: 9229XJ4V12)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPANEDIOL(UNII: 5965N8W85T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
MILK THISTLE(UNII: U946SH95EE)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM CHOLATE(UNII: NU3Y4CCH8Z)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
UREA(UNII: 8W8T17847W)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16047-0026-11 in 1 CARTON
1200 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

PRINCIPAL DISPLAY PANEL

Box