Vanicream Sunscreen Sport Broad Spectrum SPF 35

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2023-11-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:21:29

Label at a glance#

ProductVanicream Sunscreen Sport Broad Spectrum SPF 35
Active ingredientZINC OXIDE
Label structure11 sections

Storage and handling

Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc oxide 12%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • shake well before use
  • 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 SECTION

Other information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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 U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-331-03

DERMATOLOGIST TESTED

New Formula

VANICREAM™Sunscreen Sport

BROAD SPECTRUM SPF 35

MINERAL SUNSCREEN

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers

Gluten-free

for Sensitive Skin

Net Wt 3 oz (85 g)

LABELLABEL

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-33145334-331-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
09ab033c-2737-c85b-e063-6294a90a00cbb5589aa0-2b1b-358e-e053-2995a90a549a2023-11-08WarningsExact identifier
spl id: 09ab033c-2737-c85b-e063-6294a90a00cb
spl set id: b5589aa0-2b1b-358e-e053-2995a90a549a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.