Search by Drug Name or NDC

NDC 45334-0350-35 Vanicream Lip Protectant/Sunscreen 12; 15; 150 mg/g; mg/g; mg/g Details

Vanicream Lip Protectant/Sunscreen 12; 15; 150 mg/g; mg/g; mg/g

Vanicream Lip Protectant/Sunscreen is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Pharmaceutical Specialties, Inc.. The primary component is DIMETHICONE; TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	45334-0350
Product ID	45334-350_d9e0464f-e94c-91dc-e053-2995a90a91b7
Associated GPIs	90920000009300
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Vanicream Lip Protectant/Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Dimethicone, Titanium dioxide, Zinc oxide
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	TOPICAL
Active Ingredient Strength	12; 15; 150
Active Ingredient Units	mg/g; mg/g; mg/g
Substance Name	DIMETHICONE; TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Pharmaceutical Specialties, Inc.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Skin Barrier Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 45334-0350-35 (45334035035)

Pricing Information	N/A
NDC Package Code	45334-350-35
Billing NDC	45334035035
Package	1 TUBE in 1 CARTON (45334-350-35) / 10 g in 1 TUBE
Marketing Start Date	2014-09-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 26b7ffcd-d299-628e-e054-00144ff88e88 Details

Drug Facts

Active ingredients

Dimethicone 1.2%

Titanium dioxide 1.5%

Zinc oxide 15%

Purpose

Skin Protectant

Sunscreen

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

Warnings

For external use only

SPL UNCLASSIFIED SECTION

Do not use on damaged or broken skin

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if rash occurs

SPL UNCLASSIFIED SECTION

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

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

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

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

Questions?

1-800-325-8232

www.vanicream.com

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

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)

INGREDIENTS AND APPEARANCE

VANICREAM LIP PROTECTANT/SUNSCREEN

dimethicone, titanium dioxide, zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:45334-350
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	15 mg in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	150 mg in 1 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	12 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:45334-350-35	1 in 1 CARTON	09/02/2014	04/30/2024
1		10 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	09/02/2014	04/30/2024

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Name	Address	ID/FEI	Business Operations
Establishment
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-350) , pack(45334-350) , label(45334-350)

Revised: 3/2022

Document Id: d9e0464f-e94c-91dc-e053-2995a90a91b7

Set id: 26b7ffcd-d299-628e-e054-00144ff88e88

Version: 5

Effective Time: 20220310

Search by Drug Name or NDC

NDC 45334-0350-35 Vanicream Lip Protectant/Sunscreen 12; 15; 150 mg/g; mg/g; mg/g Details

Vanicream Lip Protectant/Sunscreen 12; 15; 150 mg/g; mg/g; mg/g

Product Information

Package

Package Images

NDC 45334-0350-35 (45334035035)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 26b7ffcd-d299-628e-e054-00144ff88e88 Details

Drug Facts

Active ingredients

Purpose

Uses

Warnings

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

VANICREAM™ Lip Protectant/Sunscreen

INGREDIENTS AND APPEARANCE

Concerns With Wegovy Increasing Liver Enzymes

Can You Take A Z-Pak If You Have A Penicillin Allergy?