NDC Code(s) : 71026-001-01, 71026-001-02
Packager : YADAH Co., Ltd.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

YADAH OH MY SUN BLOCKOCTINOXATE, TITANIUM DIOXIDE, OCTOCRYLENE, AVOBENZONE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71026-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE3.75 mg in 50 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.065 mg in 50 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE1 mg in 50 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE0.6 mg in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
TRICETEARETH-4 PHOSPHATE(UNII: 69534Y66NO)
GLYCOL STEARATE(UNII: 0324G66D0E)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
PEG-2 STEARATE(UNII: 94YQ11Y95F)
POTASSIUM CETYL PHOSPHATE(UNII: 03KCY6P7UT)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BERGAMOT OIL(UNII: 39W1PKE3JI)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
AMINOMETHYLPROPANOL(UNII: LU49E6626Q)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DIMETHICONE(UNII: 92RU3N3Y1O)
XANTHAN GUM(UNII: TTV12P4NEE)
EDETATE DISODIUM(UNII: 7FLD91C86K)
OPUNTIA FICUS-INDICA(UNII: 23Z87HTQ6P)
CHAMAEMELUM NOBILE FLOWER OIL(UNII: UB27587839)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
LAVANDULA ANGUSTIFOLIA WHOLE(UNII: 51217XIL5L)
DIOSPYROS KAKI LEAF(UNII: Q71GF9OBNO)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
ETHOHEXADIOL(UNII: M9JGK7U88V)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZYL ALCOHOL(UNII: LKG8494WBH)
DEHYDROACETIC ACID(UNII: 2KAG279R6R)
POTATO PULP(UNII: 844I2DX0IS)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71026-001-021 in 1 CARTON 01/02/2018
1NDC:71026-001-0150 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 01/02/2018

PRINCIPAL DISPLAY PANEL

image description