NDC Code(s) : 71026-004-01, 71026-004-02
Packager : YADAH Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

YADAH OH MY SUN SLUSHHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71026-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE95 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE50 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE45 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
OPUNTIA FICUS-INDICA(UNII: 23Z87HTQ6P)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DOCOSANOL(UNII: 9G1OE216XY)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
BIS-PEG-18 METHYL ETHER DIMETHYL SILANE(UNII: OEB4R3WW9C)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
WATER(UNII: 059QF0KO0R)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CARBOXYPOLYMETHYLENE(UNII: 0A5MM307FC)
TROMETHAMINE(UNII: 023C2WHX2V)
DEHYDROXANTHAN GUM(UNII: 63ZP7I1BQO)
GELLAN GUM (LOW ACYL)(UNII: 7593U09I4D)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BETULA PLATYPHYLLA RESIN(UNII: 1B33PG6N4K)
PURSLANE(UNII: M6S840WXG5)
SHEANUT(UNII: 84H6HBP32L)
BAMBUSA BAMBOS WHOLE(UNII: 54FV35D60A)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
MADECASSOSIDE(UNII: CQ2F5O6YIY)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71026-004-021 in 1 CARTON 08/02/2017
1NDC:71026-004-0150 mL in 1 CONTAINER 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 08/02/2017

PRINCIPAL DISPLAY PANEL

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