VANICREAM SUNSCREEN BROAD SPECTRUM SPF 30- 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.

----------

VANICREAM Sunscreen BROAD SPECTRUM SPF 30

Drug Facts

Active ingredients

Titanium dioxide 3.4%

Zinc oxide 6%

Purpose

Sunscreen

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

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

  • 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 of age: 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 a 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

Other information protect this product from excessive heat and direct sun

Inactive ingredients C20-40 alcohols, caprylyl glycol, cetyl PEG/PPG-10/1 dimethicone, cocoglycerides, dicaprylyl carbonate, dimethicone, 1,2 hexanediol, hydrogenated castor oil, hydrogenated polyisobutene, magnesium chloride, octadecene, PEG-30 dipolyhydroxystearate, pentylene glycol, phenyl trimethicone, purified water, silica, silica dimethyl silylate, squalane, stearyl dimethicone, tridecyl salicylate, triethoxycaprylylsilane, ubiquinone (coenzyme Q10)

Questions or Comments? 800-325-8232

www.vanicream.com Official Vanicream

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

Vanicream™ Sunscreen SPF 30 for sensitive skin is free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives.

  • Oil-free
  • Non-comedogenic (safe for use on face)
  • Odorless
  • Non-greasy
  • No oxybenzone
  • PABA-free
  • Gluten-free
  • Water resistant (80 minutes)

Vanicream™ Sunscreen SPF 30 is formulated with zinc oxide and titanium dioxide and does not contain sensitizing chemical sunscreens. It is lightweight, easy-to-spread, and quickly absorbed.

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

Dermatologist Recommended

When Vanicream™ Sunscreen SPF 30 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 45334-353-04

DERMATOLOGIST RECOMMENDED

VANICREAM™

Sunscreen

BROAD SPECTRUM

SPF 30

NO SENSITIZING CHEMICAL SUNSCREENS

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

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

Net Wt 4 oz (113 g)

SPF 30 4 oz Carton

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.034 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
C20-40 ALCOHOLS (MP 79C) (UNII: SBX8KS13SG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
HYDROGENATED POLYBUTENE (370 MW) (UNII: V5H8103878)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
OCTADECENE (UNII: H5ZUQ6V4AK)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
SQUALANE (UNII: GW89575KF9)  
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45334-353-041 in 1 CARTON04/19/201307/31/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:45334-353-077 g in 1 TUBE; Type 0: Not a Combination Product04/19/201304/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/19/201307/31/2019
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-353) , pack(45334-353) , label(45334-353)

Revised: 6/2019
 
Pharmaceutical Specialties, Inc.