NDC Code(s) : 72475-001-35
Packager : Cardon, Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CardonAvobenzone, Homosalate, Octyl Salicylate LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72475-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE7 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.3 g in 100 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE(UNII: 0A5MM307FC)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)(UNII: Q7UI015FF9)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)(UNII: 86FQE96TZ4)
TROMETHAMINE(UNII: 023C2WHX2V)
ISOHEXADECANE(UNII: 918X1OUF1E)
HOUTTUYNIA CORDATA WHOLE(UNII: O3E12ZLW5T)
TERT-BUTYL ALCOHOL(UNII: MD83SFE959)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
DOCOSANOL(UNII: 9G1OE216XY)
XANTHAN GUM(UNII: TTV12P4NEE)
TURMERIC(UNII: 856YO1Z64F)
PORTULACA OLERACEA WHOLE(UNII: D5J3623SV2)
CENTELLA ASIATICA(UNII: 7M867G6T1U)
SALVIA HISPANICA SEED(UNII: NU0OLX06F8)
OPUNTIA FICUS-INDICA STEM(UNII: MUD8892KHL)
WATER(UNII: 059QF0KO0R)
PROPANEDIOL(UNII: 5965N8W85T)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)(UNII: 5Z4DPO246A)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
INVERT SUGAR(UNII: ED959S6ACY)
EDETATE DISODIUM(UNII: 7FLD91C86K)
OXYGEN(UNII: S88TT14065)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
ETHYLHEXYL METHOXYCRYLENE(UNII: S3KFG6Q5X8)
POLY(METHYL METHACRYLATE; 450000 MW)(UNII: Z47NNT4J11)
GLYCERIN(UNII: PDC6A3C0OX)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:72475-001-3535 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/09/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 08/09/2018

LABELER - Cardon, Inc(081099910)

PRINCIPAL DISPLAY PANEL

CARDON

SPF + MOISTURIZER

BROAD SPECTRUM SPF 30

1.2 FL.OZ. / 35 ml

Cardon homme sunscreen PDP