FDA Label for Vanicream Sunscreen Sport Broad Spectrum Spf 35
View Indications, Usage & Precautions
Vanicream Sunscreen Sport Broad Spectrum Spf 35 Product Label
The following document was submitted to the FDA by the labeler of this product Pharmaceutical Specialties, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.
Dist. by
PHARMACEUTICAL SPECIALTIES, INC.
ROCHESTER, MN 55901 Made in USA
Otc - Active Ingredient
Active ingredient
Zinc oxide 12%
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Storage And Handling
Other information
protect this product from excessive heat and direct sun
Inactive Ingredient
Inactive ingredients allantoin, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propanediol, silica, sodium chloride, squalane, tribehenin, tridecyl salicylate, water
Otc - Questions
Questions or Comments?
800-325-8232
www.vanicream.com
Package Label.Principal Display Panel
NDC 45334-331-03
DERMATOLOGIST TESTED
New Formula
VANICREAM™Sunscreen Sport
BROAD SPECTRUM SPF 35
NO SENSITIZING CHEMICAL SUNSCREENS
WATER RESISTANT (80 MINUTES)
NON-COMEDOGENIC
Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives
Reef Friendly
for Sensitive Skin
Net Wt 3 oz (85 g)
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