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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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 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 DIOXIDE 32 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
C12-15 ALKYL 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
1 NDC:42485-005-01 75 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/14/2012
Labeler - Biopelle, Inc. (808158823)
Establishment
Name Address ID/FEI Business Operations
Englewood Lab, LLC 172198223 manufacture(42485-005)

Revised: 11/2012
Document Id: 48cda9da-ce2f-42da-9ecd-baf3d8632231
Set id: 37506766-370e-4ae4-8dbe-915a763e7c55
Version: 5
Effective Time: 20121115
 
Biopelle, Inc.