FDA.reportPublic FDA data

Vanicream Facial Moisturizer Broad Spectrum SPF30

Manufacturer
Pharmaceutical Specialties Inc
Effective date
2024-10-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:27:16

Label at a glance#

ProductVanicream Facial Moisturizer Broad Spectrum SPF30
Active ingredientZINC OXIDE
Label structure10 sections

Storage and handling

Other information protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc oxide 19.5%

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

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if swimming or sweating
  • 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 the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients water, C12-15 alkyl benzoate, isopentyldiol, squalane, glycerin, coco-caprylate/caprate, bis-octyldodecyl dimer dilinoleate/propanediol copolymer, glyceryl stearate, PEG-100 stearate, polyhydroxystearic acid, cetearyl alcohol, sucrose stearate, ceramide EOP, ceramide NG, ceramide NP, ceramide AS, ceramide AP, carnosine, phytosterols, hydrogenated lecithin, dimethicone, triethoxycaprylylsilane, polyacrylate crosspolymer-11, caprylyl glycol, 1,2-hexanediol

OTC - QUESTIONS SECTION

Questions or Comments? 1-800-325-8232

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-325-02

DERMATOLOGIST TESTED

VANICREAM™ Facial Moisturizer

BROAD SPECTRUM SPF 30

ZINC OXIDE SUNSCREEN WITH CERAMIDES

FOR SENSITIVE SKIN

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

Non-comedogenic

Gluten-free

Net Wt 2.5 oz (71 g)

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45334-325-02Vanicream Facial Moisturizer Broad Spectrum SPF3071 g in 1 TUBECREAM716
45334-325-02Vanicream Facial Moisturizer Broad Spectrum SPF301 in 1 CARTONCREAM16
45334-325-04Vanicream Facial Moisturizer Broad Spectrum SPF304 g in 1 TUBECREAM46
45334-325-07Vanicream Facial Moisturizer Broad Spectrum SPF307 g in 1 TUBECREAM76

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45334-325VANICREAM FACIAL MOISTURIZER BROAD SPECTRUM SPF30 (ZINC OXIDE) CREAM [PHARMACEUTICAL SPECIALTIES INC]6Current NDC, Legacy NDC, 4 package rows20241019_d8c9a8d0-1f24-2240-e053-2a95a90a8dee.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-32545334-325-02, 45334-325-07, 45334-325-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNOSINE8HO6PVN24WIACT
SOY STEROLPL360EPO9JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE 57848GX36YBIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEG-100 STEARATEYD01N1999RIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISOPENTYLDIOL19NOL5474QIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
WATER059QF0KO0RIACT
SQUALANEGW89575KF9IACT
GLYCERINPDC6A3C0OXIACT
CERAMIDE NGC04977SRJ5IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW)WR7H9IW2XXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERTY3J98ZR7RIACT
SUCROSE STEARATE274KW0O50MIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE APF1X8L2B00JIACT
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
Vanicream Facial Moisturizer Broad Spectrum SPF30ZINC OXIDEPharmaceutical Specialties Incd8c9a8d0-1f24-2240-e053-2a95a90a8dee2024-10-15WarningsExact identifier
ndc (package): 45334-325-04
ndc (package): 45334-325-02
ndc (package): 45334-325-07
ndc (product): 45334-325
ndc11 (package): 45334032504
ndc11 (package): 45334032507
ndc11 (package): 45334032502
spl id: 23ea8d4b-d758-a328-e063-6394a90ae6a3
spl set id: d8c9a8d0-1f24-2240-e053-2a95a90a8dee

Reported adverse events (FAERS/openFDA)#

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