NDC Code(s) : 63181-0011-1
Packager : Sesvalia USA LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

REPASKIN FACIAL, BROAD SPECTRUM SPF 50OCTOCRYLENE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63181-0011
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
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
OCTISALATE(UNII: 4X49Y0596W)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PROPANEDIOL(UNII: 5965N8W85T)
CYCLOMETHICONE(UNII: NMQ347994Z)
AVOBENZONE(UNII: G63QQF2NOX)
CETEARYL ETHYLHEXANOATE(UNII: 9M64UO4C25)
LAURYL GLUCOSIDE(UNII: 76LN7P7UCU)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE(UNII: 9229XJ4V12)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
TROLAMINE(UNII: 9O3K93S3TK)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CARBOMER COPOLYMER TYPE A(UNII: 71DD5V995L)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
EDETATE DISODIUM(UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
XANTHAN GUM(UNII: TTV12P4NEE)
HYDROLYZED JOJOBA ESTERS (ACID FORM)(UNII: UDR641JW8W)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)(UNII: 9E4CO0W6C5)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
TRIS-BHT MESITYLENE(UNII: 51DM34B894)
ALCOHOL(UNII: 3K9958V90M)
SODIUM PYRROLIDONE CARBOXYLATE(UNII: 469OTG57A2)
CAMELLIA OLEIFERA LEAF(UNII: 5077EL0C60)
MILK THISTLE(UNII: U946SH95EE)
POLYSORBATE 20(UNII: 7T1F30V5YH)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
UREA(UNII: 8W8T17847W)
THERMUS THERMOPHILUS LYSATE(UNII: 775R692494)
SODIUM CHOLATE(UNII: NU3Y4CCH8Z)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SODIUM LACTATE(UNII: TU7HW0W0QT)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ARABIDOPSIS THALIANA(UNII: AI3L60HQ81)
ALLANTOIN(UNII: 344S277G0Z)
MICROCOCCUS LUTEUS(UNII: LV6L29Z6AX)
HYDROCHLORIC ACID(UNII: QTT17582CB)
ERGOTHIONEINE(UNII: BDZ3DQM98W)
Product Characteristics
Color WHITE (Viscous hazy colorless to off-white liquid) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63181-0011-11 in 1 BOX
150 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/04/2014

PRINCIPAL DISPLAY PANEL

REPASKIN 50

FACIAL

Sunscreen gel cream

BROAD SPECTRUM SPF 50

1.7 fl oz (50 ml)

sesderma

Manufactured by:

SESDERMA S.L. Pol. Industrial Rafelbuñol. C/ Massamagrell, 5. 46138 Rafelbuñol.Valencia (Spain)

Customer service: 902 100 223.

Distributed by:

SESVALIA USA LLC.

67 Miracle Mile, Coral Gables, FL 33134 USA. USA

Customer service: (1) 800 796 0996.

www.sesderma.com

Made in SPAIN

REPASKINFACIAL50SPF