VANICREAM- titanium dioxide and zinc oxide cream 
Pharmaceutical Specialties, 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.

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VANICREAM Sunscreen BROAD SPECTRUM SPF 30

Drug Facts

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

Uses

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:45334-355
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 0.03 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 0.11 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45334-355-04 1 in 1 CARTON
1 113 g in 1 TUBE
2 NDC:45334-355-07 7 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/01/2012
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Registrant - Pharmaceutical Specialties, Inc. (076499557)
Establishment
Name Address ID/FEI Business Operations
Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-355) , pack(45334-355)

Revised: 4/2014
Document Id: 454f3ccf-e6d5-4330-98a3-3c411d6065b2
Set id: 8a4db0fc-d5b4-4eb0-8fa5-bb8cdacdb232
Version: 1
Effective Time: 20140401
 
Pharmaceutical Specialties, Inc.