FDA.reportPublic FDA data

Vanicream Lip Protectant/Sunscreen

Manufacturer
Pharmaceutical Specialties, Inc.
Effective date
2022-03-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:52:09

Label at a glance#

ProductVanicream Lip Protectant/Sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE, DIMETHICONE
Label structure14 sections

Indications and 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. helps prevent and temporarily protects chapped or cracked skin and lips helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

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 pr...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Titanium dioxide 1.5%

Zinc oxide 15%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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.
  • helps prevent and temporarily protects chapped or cracked skin and lips
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylene/ethylene/styrene copolymer, C12-15 alkyl benzoate, caprylic/capric triglyceride, ethylene/propylene/styrene copolymer, hydrogenated polyisobutene, isononyl isononanoate, microcrystalline wax, polyhydroxystearic acid, silica dimethyl silylate, stearic acid, triethoxycaprylylsilane

SPL UNCLASSIFIED SECTION

PHARMACEUTICAL SPECIALTIES, INC.

Rochester, MN 55901

Made in U.S.A.

MC15H LIP03

VANICREAM™ is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

VANICREAM™ Lip Protectant/Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 45334-350-35

DERMATOLOGIST RECOMMENDED

  • BROAD SPECTRUM SPF 30
  • WATER RESISTANT (80 MINUTES)
  • Helps prevent moisture loss
  • Helps protect from UVA/UVB rays
  • No sensitizing chemical sunscreens
  • Free of dyes, flavoring, fragrance, masking fragrance, lanolin, parabens, formaldehyde & other preservatives
  • Gluten-free

Net Wt 0.35 oz (10g)

Vanicream Lip ProtectantVanicream Lip Protectant

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45334-350-35GM - Gram45334-3505f1dc101-95d5-4d00-8d74-75f10587129b12016-05-16

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
45334-35045334-350-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISONONYL ISONONANOATES4V5BS6GCXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
DIMETHICONE92RU3N3Y1OACTIB

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
d9e0464f-e94c-91dc-e053-2995a90a91b726b7ffcd-d299-628e-e054-00144ff88e882022-03-10WarningsExact identifier
spl id: d9e0464f-e94c-91dc-e053-2995a90a91b7
spl set id: 26b7ffcd-d299-628e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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