FDA.reportPublic FDA data

Vanicream Sunscreen Broad Spectrum SPF 50

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2024-10-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:50:49

Label at a glance#

ProductVanicream Sunscreen Broad Spectrum SPF 50
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, dimethiconol/propylsilsesquioxane/silicate crosspolymer, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isodecyl salicylate, isopropyl isostearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propanediol, silica silylate, 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. ©PSI 2020. All rights reserved.

Dist. by

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-332-03

DERMATOLOGIST TESTED

New Formula

VANICREAM™ Sunscreen

BROAD SPECTRUM SPF 50+

MINERAL SUNSCREEN

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

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

Gluten-Free

for Sensitive Skin

Net Wt 3 oz (85 g)

Vanicream Sunscreen Broad Spectrum SPF50+Vanicream Sunscreen Broad Spectrum SPF50+

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-33245334-332-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
ALLANTOIN344S277G0ZIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW)9KB5R958PBIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
GLYCERYL 1,3-DIBEHENATE84T2X52XS0IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISODECYL SALICYLATES7097PFP4CIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
WATER059QF0KO0RIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYESTER-70841698D2FIACT
SQUALANEGW89575KF9IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
PROPANEDIOL5965N8W85TIACT
SILICA, TRIMETHYLSILYL CAPPEDVU10KU4B9SIACT
TRIBEHENIN8OC9U7TQZ0IACT
ZINC OXIDESOI2LOH54ZACTIB

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
25b7b781-a201-3864-e063-6394a90a1274b5597ee1-9f82-702e-e053-2a95a90aaa7b2024-10-30WarningsExact identifier
spl id: 25b7b781-a201-3864-e063-6394a90a1274
spl set id: b5597ee1-9f82-702e-e053-2a95a90aaa7b

Reported adverse events (FAERS/openFDA)#

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