VANICREAM LIP PROTECTANT/SUNSCREEN- dimethicone, titanium dioxide, zinc oxide ointment

Vanicream Lip Protectant/Sunscreen by

Drug Labeling and Warnings

Vanicream Lip Protectant/Sunscreen by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Dimethicone 1.2%

Titanium dioxide 1.5%

Zinc oxide 15%

Purpose

Skin Protectant

Sunscreen

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

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Pharmaceutical Specialties, Inc. (076499557)

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