NDC Code(s) : 42485-005-01
Packager : Biopelle, Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Broad Spectrum SPF 30 Up The AntiTITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42485-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE32 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PEG-100 STEARATE(UNII: YD01N1999R)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CETYL ALCOHOL(UNII: 936JST6JCN)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)(UNII: 1DXE3F3OZX)
GLYCERIN(UNII: PDC6A3C0OX)
CYCLOMETHICONE 6(UNII: XHK3U310BA)
CAPRYLYL TRISILOXANE(UNII: Q95M2P1KJL)
ALUMINUM OXIDE(UNII: LMI26O6933)
ISOHEXADECANE(UNII: 918X1OUF1E)
BORON NITRIDE(UNII: 2U4T60A6YD)
SODIUM LEVULINATE(UNII: VK44E1MQU8)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
SODIUM ANISATE(UNII: F9WFJ28MV9)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PANTHENOL(UNII: WV9CM0O67Z)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
DMDM HYDANTOIN(UNII: BYR0546TOW)
ALLANTOIN(UNII: 344S277G0Z)
EDETATE SODIUM(UNII: MP1J8420LU)
METHYLPARABEN(UNII: A2I8C7HI9T)
ETHYLPARABEN(UNII: 14255EXE39)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
ISOBUTYLPARABEN(UNII: 0QQJ25X58G)
MATRICARIA CHAMOMILLA WHOLE(UNII: 2Z4LRR776S)
CAMELLIA SINENSIS WHOLE(UNII: C5M4585ZBZ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42485-005-0175 mL in 1 BOTTLE Type 0: Not a Combination Product19/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 11/14/2012

LABELER - Biopelle, Inc.(808158823)

Establishment
Name Address ID/FEI Business Operations
Englewood Lab, Inc. 172198223 manufacture(42485-005)

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