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VANICREAM

Pharmaceutical Specialties, Inc.
Pharmaceutical Specialties, Inc.

VANICREAM Sunscreen BROAD SPECTRUM SPF 30


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Active Ingredients: Purpose
Titanium Dioxide 5% Sunscreen
Zinc Oxide 7% Sunscreen

VANICREAM 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, 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)

Other information 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

VANICREAM

VANICREAM™

Sunscreen

BROAD SPECTRUM

SPF 50+

NO SENSITIZING CHEMICAL SUNSCREENS

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

VANICREAM

VANICREAM™

BROAD SPECTRUM

SPF 50+

WATER RESISTANT (80 MINUTES) - NON-COMEDOGENIC

NO SENSITIZING CHEMICAL SUNSCREENS

PHARMACEUTICAL SPECIALITIES, INC. 800-325-8232 www.vaniceram.com Made In USA

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 label Item Code (Source) NDC:45334-356
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 0.05 g
Zinc Oxide Zinc oxide 0.07 g

Inactive Ingredients

Ingredient Name Strength
CAPRYLYL GLYCOL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
coco-glycerides
DICAPRYLYL CARBONATE
DIMETHICONE
HEXANEDIOL
HYDROGENATED CASTOR OIL
HYDROGENATED POLYBUTENE (1300 MW)
MAGNESIUM CHLORIDE
OCTADECENE
PEG-30 DIPOLYHYDROXYSTEARATE
PENTYLENE GLYCOL
PHENYL TRIMETHICONE
water
SILICON DIOXIDE
SILICA DIMETHYL SILYLATE
SQUALANE
STEARYL DIMETHICONE (400 MPA.S AT 50C)
TRIDECYL SALICYLATE
TRIETHOXYCAPRYLYLSILANE
UBIDECARENONE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 113 in 1 TUBE
2 NDC:45334-356-07 7 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-02-01


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