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VANICREAM Sunscreen BROAD SPECTRUM SPF 35

Medically reviewed by Drugs.com. Last updated on Oct 11, 2017.

Dosage form: cream
Ingredients: OCTINOXATE 0.028g in 1g, ZINC OXIDE 0.11g in 1g
Labeler: Pharmaceutical Specialties, Inc.
NDC Code: 45334-355

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 Sport BROAD SPECTRUM SPF 35

Drug Facts

Active ingredients

Octinoxate 2.8%
Zinc Oxide 11%

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, 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.

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

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)

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35 
octinoxate and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-355
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.028 g  in 1 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE0.11 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
C20-40 ALCOHOLS (MP 79C) 
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) 
CYCLOMETHICONE 6 
CYCLOMETHICONE 5 
CYCLOMETHICONE 4 
DIMETHICONOL GUM 
GLYCERIN 
HYDROGENATED CASTOR OIL 
MAGNESIUM CHLORIDE 
PEG-30 DIPOLYHYDROXYSTEARATE 
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED 
WATER 
TRIDECYL NEOPENTANOATE 
UBIDECARENONE 
TRIETHOXYCAPRYLYLSILANE 
SILICA, TRIMETHYLSILYL CAPPED 
Packaging
#Item CodePackage Description
1NDC:45334-355-041 TUBE in 1 CARTON
1113 g in 1 TUBE
2NDC:45334-355-0257 g in 1 TUBE
3NDC:45334-355-077 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/18/2013
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-355), pack(45334-355)

 
Pharmaceutical Specialties, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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