NDC Code(s) : 42893-013-00
Packager : Chantecaille Beaute Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42893-013
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
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE27.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
ROSA DAMASCENA FLOWER OIL(UNII: 18920M3T13)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLYMETHYLSILSESQUIOXANE (11 MICRONS)(UNII: Z570VEV8XK)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
ISONONYL ISONONANOATE(UNII: S4V5BS6GCX)
GLYCERIN(UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYGLYCERYL-2 MONOISOSTEARATE(UNII: 7B8OE71MQC)
EDETATE SODIUM(UNII: MP1J8420LU)
TOCOPHEROL(UNII: R0ZB2556P8)
OCIMUM AFRICANUM LEAF(UNII: 0231102WJO)
STEARYL GLYCYRRHETINATE(UNII: 3YYE6VJS0P)
CARNOSINE(UNII: 8HO6PVN24W)
EGG PHOSPHOLIPIDS(UNII: 1Z74184RGV)
TEA LEAF(UNII: GH42T47V24)
PRUNUS X YEDOENSIS LEAF(UNII: 1Z125GA907)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42893-013-0040 mL in 1 TUBE Type 0: Not a Combination Product30/07/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 07/30/2014

LABELER - Chantecaille Beaute Inc(095270166)

PRINCIPAL DISPLAY PANEL

CHANTECAILLE Ultra Sun Protection Sunscreen Broad Spectrum SPF 45

40ml 1.3 fl oz

Ultra Sun LabelUltra Sun Label