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

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information protect this product from excessive heat and direct sun

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)

Questions or Comments? 800-325-8232
www.vanicream.com Official Vanicream

PHARMACEUTlCAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

Vanicream™ Sunscreen Sport SPF 35 for sensitive skin is free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives.

Formulated with zinc oxide and octinoxate, Vanicream™ Sunscreen Sport SPF 35 is lightweight, easy-to-spread, quickly absorbed, and transparent.

Recommended for daily use by the entire family. Ideal for even the most delicate, sensitive skin. ( see Directions)

Dermatologist Recommended

When Vanicream™ Sunscreen Sport SPF 35 is used as directed with other sun protective measures, it helps provide protection from the sun's harmful rays (UVA and UVB) and decreases the risk of skin cancer and skin aging.

Coenzyme Q10 is an antioxidant which helps prevent damage to the skin by neutralizing free radicals produced when skin is exposed to the sun.

For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232.

Official Vanicream

for Sensitive Skin

Kid Friendly

NDC 45334-355-04

DERMATOLOGIST RECOMMENDED

VANICREAM™

Sunscreen Sport

BROAD SPECTRUM

SPF 35

FOR SENSITIVE SKIN

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde, & other preservatives

Net Wt. 4 oz (113 g)

SPF 35 4 oz carton MC15O

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
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)  
SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:45334-355-04 1 in 1 CARTON 04/18/2013
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 04/18/2013
3 NDC:45334-355-07 7 g in 1 TUBE; Type 0: Not a Combination Product 04/18/2013
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)
Establishment
Name Address ID/FEI Business Operations
Pharmaceutical Specialties, Inc. 076499557 manufacture(45334-355) , pack(45334-355)

Revised: 10/2017
Document Id: 5b42924a-7cc5-8f2e-e053-2a91aa0a6c70
Set id: 8a4db0fc-d5b4-4eb0-8fa5-bb8cdacdb232
Version: 3
Effective Time: 20171011
 
Pharmaceutical Specialties, Inc.