BROAD SPECTRUM SPF 30 UP THE ANTI- titanium dioxide, zinc oxide cream 
Biopelle, Inc.

----------

Broad Spectrum SPF 30 Up The Anti

Broad Spectrum SPF 30 Up The Anti


Active Ingredients

Zinc Oxide 6.0% Titanium Dioxide 3.2%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

water, ethylhexyl palmitate, cyclopentasiloxane, c12-15 alkyl benzoate, dimethicone, polysorbate 80, peg-100 stearate, glyceryl stearate, propylene glycol, polyglyceryl-6 isostearatem cetyl alcohol, sodium acrylate/sodium acryloyldimethyl laurate copolymer, glycerin, cyclohexasiloxane, caprylyl methicone, alumina, isohexadecane, boron nitride, triethoxysilylethyl polydimethylsiloxy hexyl dimethicone, sodium levulinate, lauryl  peg-9 polydimethylsiloxyethyl dimethicone, acrylates/ammonium methacrylate copolymer, phenoxyethanol, polyhydroxystearic acid, sodium anisate, triethoxycaprylylsilane, panthenol, iodopropynyl butylcarbamate, dmdm hydantoin, aloe barbadensis leaf juice, allantoin, disodium edta, methylparaben, ethylparaben, butylparaben, butylene glycol, propylparaben, isobutylparaben, chamomilla recutita (matricaria) flower extract, camellia sinensis leaf extract, iron oxides.

Other Information

Questions or comments?

Call toll free 1-866-424-6735 (weekdays)

PRESCRIBEDsolutions is Distributed By Biopelle, Inc.

A Ferndale Pharma Group Company, Ferndale, MI 48220

Made In USA

Broad Spectrum SPF 30 Up The Anti 75ml (42485-005-01)


UPTHEANTI

UPTHEANTIBase

BROAD SPECTRUM SPF 30 UP THE ANTI 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42485-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42485-005-0175 mL in 1 BOTTLE; Type 0: Not a Combination Product12/19/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/14/2012
Labeler - Biopelle, Inc. (808158823)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, Inc.172198223manufacture(42485-005)

Revised: 12/2023
Document Id: 0c5b3fe9-1841-0f34-e063-6294a90ad802
Set id: 37506766-370e-4ae4-8dbe-915a763e7c55
Version: 11
Effective Time: 20231212
 
Biopelle, Inc.