Your browser does not support JavaScript! BROAD SPECTRUM SPF 30 UP THE ANTI (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [BIOPELLE, INC.]
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BROAD SPECTRUM SPF 30 UP THE ANTI (titanium dioxide, zinc oxide) cream
[Biopelle, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Broad Spectrum SPF 30 Up The Anti


Active Ingredients

Zinc Oxide 6.0%
Titanium Dioxide 3.2%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

  • apply to face and under throat after cleansing
  • reapply:
    • after excessive perspiration
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m.  - 2 p.m.
    • wear long sleeve shirts, pants, hats and sunglasses
  • children under 6 months: Ask a doctor

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

  • protect this product from excessive heat and direct sun

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 DRUG LABELItem Code (Source)NDC:42485-005
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE32 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
CYCLOMETHICONE 5 
C12-15 ALKYL BENZOATE 
DIMETHICONE 
POLYSORBATE 80 
PEG-100 STEARATE 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
CETYL ALCOHOL 
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) 
GLYCERIN 
CYCLOMETHICONE 6 
CAPRYLYL TRISILOXANE 
ALUMINUM OXIDE 
ISOHEXADECANE 
BORON NITRIDE 
SODIUM LEVULINATE 
PHENOXYETHANOL 
POLYHYDROXYSTEARIC ACID (2300 MW) 
SODIUM ANISATE 
TRIETHOXYCAPRYLYLSILANE 
PANTHENOL 
IODOPROPYNYL BUTYLCARBAMATE 
ALOE VERA LEAF 
DMDM HYDANTOIN 
ALLANTOIN 
EDETATE SODIUM 
METHYLPARABEN 
ETHYLPARABEN 
BUTYLPARABEN 
BUTYLENE GLYCOL 
PROPYLPARABEN 
ISOBUTYLPARABEN 
MATRICARIA CHAMOMILLA WHOLE 
CAMELLIA SINENSIS WHOLE 
FERRIC OXIDE RED 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42485-005-0175 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/14/2012
Labeler - Biopelle, Inc. (808158823)
Establishment
NameAddressID/FEIBusiness Operations
Englewood Lab, LLC172198223manufacture(42485-005)

Revised: 11/2012
 
Biopelle, Inc.

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