Your browser does not support JavaScript! VANICREAM (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES, INC.]
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VANICREAM (titanium dioxide and zinc oxide) cream
[Pharmaceutical Specialties, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph 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

Drug Facts

Active Ingredients:Purpose
Titanium Dioxide 3%Sunscreen
Zinc Oxide 11%Sunscreen

Uses

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

Warnings

For external use only

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

Stop use and ask a doctor if rash occurs

Do not use on damaged or broken skin

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • children under 6 months: Ask a doctor
  • 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. -2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

C20-40 alcohols, cetyl PEG/PPG-1 0/1 dimethicone, cyclohexasiloxane, cyclopentasiloxane, cyclotetrasiloxane, dimethiconol, glycerin, hydrogenated castor oil, magnesium chloride, PEG-30 dipolyhydroxystearate, polypropyl silsesquioxane, purified water, tridecyl neopentanoate, triethoxycaprylylsilane, trimethylsiloxy silicate, ubiquinone (coenzyme Q10)

Other information protect this product from excessive heat and direct sun

Questions or Comments 800-325-8232

www.vanicream.com official Vanicream

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

PRINCIPAL DISPLAY PANEL - 113g Tube Carton

VANICREAM™

Sunscreen Sport

BROAD SPECTRUM

SPF 35

FOR SENSITIVE SKIN

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

Free of dyes, lanolin, fragrance,

masking fragrance,

parabens, formaldehyde,

& other preservatives

Net Wt 4 oz (113 g)

PRINCIPAL DISPLAY PANEL - 7 g Tube Label

PRINCIPAL DISPLAY PANEL - 7 g Tube Label

VANICREAM™

BROAD SPECTRUM

SPF 35

WATER RESISTANT (80 MINUTES) - NON-COMEDOGENIC

PHARMACEUTICAL SPECIALITIES, INC. Made In USA

www.vaniceram.com 800-325-8232

SUNSCREEN SPORT

For Sensitive Skin

Free of dyes, lanolin, fragrance, masking fragrance,

parabens, formaldehyde,

&

other preservatives

VANICREAM 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:45334-355
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide0.03 g  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide0.11 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CYCLOMETHICONE 6 
CYCLOMETHICONE 5 
CYCLOMETHICONE 4 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
DIMETHICONOL (40 CST) 
GLYCERIN 
HYDROGENATED CASTOR OIL 
MAGNESIUM CHLORIDE 
PEG-30 DIPOLYHYDROXYSTEARATE 
WATER 
TRIDECYL NEOPENTANOATE 
TRIETHOXYCAPRYLYLSILANE 
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) 
UBIDECARENONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45334-355-041 in 1 CARTON
1113 g in 1 TUBE
2NDC:45334-355-077 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/01/2012
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Registrant - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-355), pack(45334-355)

Revised: 4/2014
 
Pharmaceutical Specialties, Inc.

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