NDC Code(s) : 67879-308-11, 67879-308-51
Packager : PHARMAGEL INTERNATIONAL INC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DERMA BRITE OCTINOXATE, OCTISALATE, OXYBENZONE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-308
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE7.5 g in 100 g
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TANGERINE PEEL(UNII: JU3D414057)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
DIMETHICONE(UNII: 92RU3N3Y1O)
PALMITIC ACID(UNII: 2V16EO95H1)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
STEARIC ACID(UNII: 4ELV7Z65AP)
MYRISTYL MYRISTATE(UNII: 4042ZC00DY)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 71DD5V995L)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)(UNII: R33S7TK2EP)
TROLAMINE(UNII: 9O3K93S3TK)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ALLANTOIN(UNII: 344S277G0Z)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
MYRISTYL LAURATE(UNII: 58U0NZN2BT)
PANTHENOL(UNII: WV9CM0O67Z)
EDETATE SODIUM(UNII: MP1J8420LU)
GLYCOLIC ACID(UNII: 0WT12SX38S)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
MORUS ALBA LEAF(UNII: M8YIA49Q2P)
MYRISTIC ACID(UNII: 0I3V7S25AW)
KOJIC ACID(UNII: 6K23F1TT52)
MAGNESIUM ASCORBYL PHOSPHATE(UNII: 0R822556M5)
NIACIN(UNII: 2679MF687A)
PHYLLANTHUS EMBLICA FRUIT(UNII: YLX4CW2576)
UNDECYLENOYL PHENYLALANINE(UNII: 271P08C6OD)
GLYCYRRHIZA GLABRA(UNII: 2788Z9758H)
ARACHIDIC ACID(UNII: PQB8MJD4RB)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CYPERUS ROTUNDUS ROOT(UNII: 4B51SRR959)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
LINALOOL, (+)-(UNII: F4VNO44C09)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
.BETA.-CITRONELLOL, (+/-)-(UNII: 565OK72VNF)
SODIUM BENZOATE(UNII: OJ245FE5EU)
LACTIC ACID(UNII: 33X04XA5AT)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
BIOTIN(UNII: 6SO6U10H04)
FD&C RED NO. 40(UNII: WZB9127XOA)
UNDECYLENIC ACID(UNII: K3D86KJ24N)
CHLORPHENESIN(UNII: I670DAL4SZ)
BENZOIC ACID(UNII: 8SKN0B0MIM)
SORBIC ACID(UNII: X045WJ989B)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67879-308-511 in 1 BOX 13/06/2016
1NDC:67879-308-1156 g in 1 JAR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 06/18/2015

LABELER - PHARMAGEL INTERNATIONAL INC(603215182)

PRINCIPAL DISPLAY PANEL

DERB_1_RL-1_box_final.jpg