VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate 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 Sport BROAD SPECTRUM SPF 35

Drug Facts

Active Ingredients

Octinoxate 2.8%
Zinc Oxide 11%

Purpose

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-10/1 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

PHARMACEUTlCAL SPECIALTIES, INC.

ROCHESTER, MN 55903-6298 Made in USA

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carton image

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 
octinoxate 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
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.028 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
C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 4 (UNII: CZ227117JE)  
DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
WATER (UNII: 059QF0KO0R)  
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
UBIDECARENONE (UNII: EJ27X76M46)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
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; Type 0: Not a Combination Product
2 NDC:45334-355-02 57 g in 1 TUBE; Type 0: Not a Combination Product
3 NDC:45334-355-07 7 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 04/18/2013
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: 3/2015
Document Id: 09bea3f0-babf-442b-92f5-cf4b4a3d7353
Set id: 8a4db0fc-d5b4-4eb0-8fa5-bb8cdacdb232
Version: 2
Effective Time: 20150327
 
Pharmaceutical Specialties, Inc.