NDC Code(s) : 16047-0025-1
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 30OCTOCRYLENE, PHENYLBENZIMIDAZOLE SULFONIC ACID GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16047-0025
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE50 mg in 1 mL
ENSULIZOLE(UNII: 9YQ9DI1W42)
(ENSULIZOLE - UNII:9YQ9DI1W42) 		ENSULIZOLE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
ALLANTOIN(UNII: 344S277G0Z)
ARABIDOPSIS THALIANA(UNII: AI3L60HQ81)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
AVOBENZONE(UNII: G63QQF2NOX)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
CAMELLIA OLEIFERA LEAF(UNII: 5077EL0C60)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETEARYL ETHYLHEXANOATE(UNII: 9M64UO4C25)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
OCTISALATE(UNII: 4X49Y0596W)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYDROLYZED JOJOBA ESTERS (ACID FORM)(UNII: UDR641JW8W)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
METHYLPARABEN(UNII: A2I8C7HI9T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE(UNII: 9229XJ4V12)
POLYSORBATE 20(UNII: 7T1F30V5YH)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
PROPANEDIOL(UNII: 5965N8W85T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TROLAMINE(UNII: 9O3K93S3TK)
UREA(UNII: 8W8T17847W)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:16047-0025-11 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

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