VANICREAM Sunscreen BROAD SPECTRUM SPF 30

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2019-06-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-02 00:21:11

Label at a glance#

ProductVANICREAM Sunscreen BROAD SPECTRUM SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 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 ingredients

Titanium dioxide 3.4%

Zinc oxide 6%

OTC - PURPOSE SECTION

Purpose

Sunscreen

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

  • 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 C20-40 alcohols, caprylyl glycol, cetyl PEG/PPG-10/1 dimethicone, cocoglycerides, dicaprylyl carbonate, dimethicone, 1,2 hexanediol, hydrogenated castor oil, hydrogenated polyisobutene, magnesium chloride, octadecene, PEG-30 dipolyhydroxystearate, pentylene glycol, phenyl trimethicone, purified water, silica, silica dimethyl silylate, squalane, stearyl dimethicone, tridecyl salicylate, triethoxycaprylylsilane, ubiquinone (coenzyme Q10)

OTC - QUESTIONS SECTION

Questions or Comments? 800-325-8232

www.vanicream.com Official Vanicream

SPL UNCLASSIFIED SECTION

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901 Made in USA

SPL UNCLASSIFIED SECTION

Vanicream™ Sunscreen SPF 30 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)

Vanicream™ Sunscreen SPF 30 is formulated with zinc oxide and titanium dioxide and does not contain sensitizing chemical sunscreens. It is lightweight, easy-to-spread, and quickly absorbed.

Recommended for daily use by the entire family. Ideal for even the most delicate, sensitive skin. (see Directions)

SPL UNCLASSIFIED SECTION

Dermatologist Recommended

When Vanicream™ Sunscreen SPF 30 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-353-04

DERMATOLOGIST RECOMMENDED

VANICREAM™

Sunscreen

BROAD SPECTRUM

SPF 30

NO SENSITIZING CHEMICAL SUNSCREENS

WATER RESISTANT (80 MINUTES)

NON-COMEDOGENIC

Free of dyes, fragrance, masking fragrance, lanolin, parabens, formaldehyde, & other preservatives

Net Wt 4 oz (113 g)

SPF 30 4 oz CartonSPF 30 4 oz Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45334-353-04GM - Gram45334-353105686a4-07d0-4ae6-bc0c-31989ec8d25e12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z1
Titanium DioxideACTIVE MOIETY15FIX9V2JP1
Zinc OxideACTIVE MOIETYSOI2LOH54Z1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)INACTIVE INGREDIENT035JKJ76MT1
COCO-GLYCERIDESINACTIVE INGREDIENTISE9I7DNUG1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUA1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
HEXANEDIOLINACTIVE INGREDIENTZIA319275I1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEY1
HYDROGENATED POLYBUTENE (1300 MW)INACTIVE INGREDIENT7D1YQ9Y5EZ1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
OCTADECENEINACTIVE INGREDIENTH5ZUQ6V4AK1
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FO1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
PHENYL TRIMETHICONEINACTIVE INGREDIENTDR0K5NOJ4R1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SQUALANEINACTIVE INGREDIENTGW89575KF91
STEARYL DIMETHICONE (400 MPA.S AT 50C)INACTIVE INGREDIENTR327X197HY1
TRIDECYL SALICYLATEINACTIVE INGREDIENTAZQ08K38Z11
TRIETHOXYCAPRYLYLSILANEINACTIVE INGREDIENTLDC331P08E1
UBIDECARENONEINACTIVE INGREDIENTEJ27X76M461
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-35345334-353-04, 45334-353-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYLIQUID / TOPICAL0.24 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FOR SUSPENSION / ORAL220 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / SUBLINGUAL1.6 mgExact identifier — unii candidate
12 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9AEROSOL, FOAM / TOPICAL2.23 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9CREAM, AUGMENTED / TOPICAL120 mgExact identifier — unii candidate
5 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SOLUTION / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAOCULAR15 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, EXTENDED RELEASE / ORAL168 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FILM COATED / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, DELAYED RELEASE / ORAL1337 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CREAM / VAGINAL51 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER, FOR SOLUTION / ORAL280 mgExact identifier — unii candidate
49 equally ranked IID candidates
SQUALANESQUALANEGW89575KF9SOLUTION / TOPICAL1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, DELAYED RELEASE / ORAL40 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, DELAYED RELEASE / ORAL3.2 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, EXTENDED RELEASE / ORAL393 mgExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PELLET / ORAL34 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TAMPON / VAGINALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / DENTAL19 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, EXTENDED RELEASE / ORAL450 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SUSPENSION, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE, DELAYED RELEASE / ORAL3.1 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4POWDER / ORAL602 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OINJECTION, SUSPENSION / INTRAVITREAL0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET, FOR SUSPENSION / ORAL17 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, ORALLY DISINTEGRATING / ORAL68 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION / INTRAPERITONEAL0.01 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCREAM / VAGINAL50 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WCAPSULE / ORAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4PASTE / DENTAL34 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYCAPSULE / ORAL405 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYTABLET / ORAL232 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE, LIQUID FILLED / ORAL106 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / VAGINAL8 %w/wExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, COATED / ORAL176 mgExact identifier — unii candidate
49 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYSUSPENSION / TOPICAL286 mgExact identifier — unii candidate
12 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / SUBLINGUAL2 mgExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
7 equally ranked IID candidates
HYDROGENATED CASTOR OILHYDROGENATED CASTOR OILZF94AP8MEYAEROSOL, FOAM / TOPICAL2 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSUSPENSION / AURICULAR (OTIC)0.06 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4DROPS / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE, FOR SOLUTION / ORAL1.8 mg/120mlExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / BUCCAL3 mgExact identifier — unii candidate
49 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, DELAYED RELEASE / ORAL1190 mgExact identifier — unii candidate
49 equally ranked IID candidates

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
8b21011e-27ed-25d1-e053-2995a90afa6023e7cede-ef60-4052-a2b2-55cf8d60d4812019-06-12WarningsExact identifier
spl id: 8b21011e-27ed-25d1-e053-2995a90afa60
spl set id: 23e7cede-ef60-4052-a2b2-55cf8d60d481

Reported adverse events (FAERS/openFDA)#

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