NDC Code(s) : 69231-006-01, 69231-006-02
Packager : KW ABSC, INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CCC Cream MediumOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69231-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE2.25 mg in 30 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE0.9 mg in 30 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE2.7 mg in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
AMILOXATE(UNII: 376KTP06K8)
NIACINAMIDE(UNII: 25X51I8RD4)
DICAPRYLYL CARBONATE(UNII: 609A3V1SUA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3)(UNII: G300307ZXP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
BEMOTRIZINOL(UNII: PWZ1720CBH)
CERESIN(UNII: Q1LS2UJO3A)
DIISOSTEARYL MALATE(UNII: QBS8A3XZGQ)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
MICA(UNII: V8A1AW0880)
FERRIC OXIDE RED(UNII: 1K09F3G675)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: 25G622K2RA)
SORBITAN OLIVATE(UNII: MDL271E3GR)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
DIMETHICONE(UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)(UNII: UF7620L1W6)
ADENOSINE(UNII: K72T3FS567)
1,2-HEXANEDIOL(UNII: TR046Y3K1G)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
EDETATE DISODIUM(UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
CHRYSANTHEMUM INDICUM FLOWER(UNII: I6OER6U04L)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
ROSEMARY(UNII: IJ67X351P9)
ASPALATHUS LINEARIS LEAF(UNII: H7UGK1GJCU)
THYME(UNII: CW657OBU4N)
JASMINUM OFFICINALE FLOWER(UNII: 0Q8K841432)
TOCOPHEROL(UNII: R0ZB2556P8)
COCONUT OIL(UNII: Q9L0O73W7L)
LOWBUSH BLUEBERRY(UNII: G90PX41VP0)
BAMBUSA VULGARIS TOP(UNII: FIW80T6P6V)
GLYCERIN(UNII: PDC6A3C0OX)
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69231-006-021 in 1 PACKAGE 28/12/2015
1NDC:69231-006-0130 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 12/28/2015

PRINCIPAL DISPLAY PANEL

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