Label: VANICREAM- titanium dioxide and zinc oxide cream
- NDC Code(s): 45334-355-04, 45334-355-07
- Packager: Pharmaceutical Specialties, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active Ingredients: Purpose Titanium Dioxide 3% Sunscreen Zinc Oxide 11% Sunscreen
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- apply liberally 15 minutes before sun exposure
- 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, cetyl PEG/PPG-1 0/1 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)Close
- STORAGE AND HANDLING
Other information protect this product from excessive heat and direct sunClose
Questions or Comments 800-325-8232
www.vanicream.com official VanicreamClose
- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
FOR SENSITIVE SKIN
WATER RESISTANT (80 MINUTES)
Free of dyes, lanolin, fragrance,
& other preservatives
Net Wt 4 oz (113 g)Close
- PRINCIPAL DISPLAY PANEL - 7 g Tube Label
- INGREDIENTS AND APPEARANCE
titanium dioxide and zinc oxide cream
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:45334-355 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (Titanium Dioxide) Titanium Dioxide 0.03 g in 1 g Zinc Oxide (Zinc Oxide) Zinc Oxide 0.11 g in 1 g Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 CYCLOMETHICONE 5 CYCLOMETHICONE 4 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) DIMETHICONOL (40 CST) GLYCERIN HYDROGENATED CASTOR OIL MAGNESIUM CHLORIDE PEG-30 DIPOLYHYDROXYSTEARATE WATER TRIDECYL NEOPENTANOATE TRIETHOXYCAPRYLYLSILANE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) UBIDECARENONE 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 2 NDC:45334-355-07 7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2012 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)