NDC Code(s) : 69231-011-01, 69231-011-02
Packager : KW ABSC, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Essence Air Cushion MediumOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69231-011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE1.13 mg in 15 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.45 mg in 15 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE1.28 mg in 15 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
AMILOXATE(UNII: 376KTP06K8)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
NIACINAMIDE(UNII: 25X51I8RD4)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
BEMOTRIZINOL(UNII: PWZ1720CBH)
DIMETHICONE(UNII: 92RU3N3Y1O)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)(UNII: 5041RX63GN)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SORBITAN OLIVATE(UNII: MDL271E3GR)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)(UNII: H895X08VNQ)
YELLOW WAX(UNII: 2ZA36H0S2V)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
TALC(UNII: 7SEV7J4R1U)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
TRIHYDROXYSTEARIN(UNII: 06YD7896S3)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
SQUALANE(UNII: GW89575KF9)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
DIMETHICONOL (40 CST)(UNII: 343C7U75XW)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
ADENOSINE(UNII: K72T3FS567)
EDETATE DISODIUM(UNII: 7FLD91C86K)
Chrysanthemum Indicum Flower(UNII: I6OER6U04L)
ROSA DAMASCENA FLOWER OIL(UNII: 18920M3T13)
LILIUM CANDIDUM FLOWER(UNII: COV655U2CJ)
PURSLANE(UNII: M6S840WXG5)
VIOLA TRICOLOR(UNII: 9Q24RAI43V)
HEDERA HELIX LEAF(UNII: ZP9XFG71A7)
SALVIA OFFICINALIS ROOT(UNII: 236QY0A1BL)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
SHEA BUTTER(UNII: K49155WL9Y)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
BETULA PUBESCENS RESIN(UNII: 9G931M6I4G)
PAEONIA LACTIFLORA ROOT(UNII: 3Z3866YW6P)
PEARL (HYRIOPSIS CUMINGII)(UNII: A75L5FZ40U)
CHAMOMILE(UNII: FGL3685T2X)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT(UNII: SDW6SS1K6I)
GLYCERIN(UNII: PDC6A3C0OX)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CALCIUM PANTOTHENATE(UNII: 568ET80C3D)
TOCOPHEROL(UNII: R0ZB2556P8)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
VERONICA OFFICINALIS FLOWERING TOP(UNII: 9IH82J936J)
MELISSA OFFICINALIS LEAF(UNII: 50D2ZE9219)
MALVA SYLVESTRIS FLOWERING TOP(UNII: X1U1U0N90J)
ACHILLEA MILLEFOLIUM(UNII: 2FXJ6SW4PK)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP(UNII: 9M289NKI69)
ALCOHOL(UNII: 3K9958V90M)
PRIMULA VERIS(UNII: W6LFQ57E4M)
MENTHA PIPERITA LEAF(UNII: A389O33LX6)
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
COCONUT OIL(UNII: Q9L0O73W7L)
LOWBUSH BLUEBERRY(UNII: G90PX41VP0)
BAMBUSA VULGARIS TOP(UNII: FIW80T6P6V)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69231-011-021 in 1 PACKAGE 28/12/2015
1NDC:69231-011-0115 g 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 12/28/2015

PRINCIPAL DISPLAY PANEL

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