NDC Code(s) : 67692-434-00
Packager : Lumene Oy

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lumene Sisu Moisture Remedy Day Sunscreen Broad Spectrum SPF 20AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67692-434
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE80 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
GLYCERIN(UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CETYL PALMITATE(UNII: 5ZA2S6B08X)
PROPANEDIOL(UNII: 5965N8W85T)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
PINUS SYLVESTRIS LEAFY TWIG(UNII: Q1RGP4UB73)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
MICA(UNII: V8A1AW0880)
DIISOPROPYL ADIPATE(UNII: P7E6YFV72X)
XANTHAN GUM(UNII: TTV12P4NEE)
ALCOHOL(UNII: 3K9958V90M)
EDETATE DISODIUM ANHYDROUS(UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POLYSORBATE 60(UNII: CAL22UVI4M)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
DIMETHYLMETHOXY CHROMANOL(UNII: XBH432G01F)
GLYCERYL CAPRATE(UNII: 197M6VFC1W)
BIOSACCHARIDE GUM-4(UNII: 9XRL057X90)
BIOSACCHARIDE GUM-1(UNII: BB4PU4V09H)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67692-434-001 in 1 BOX 07/04/2017
150 mL in 1 JAR 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 07/04/2017

PRINCIPAL DISPLAY PANEL

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