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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

Pharmaceutical Specialties, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Skin Protectant Sunscreen Sunscreen - 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 Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

VANICREAM LIP PROTECTANT/SUNSCREEN- DIMETHICONE, TITANIUM DIOXIDE,
ZINC OXIDE OINTMENT
PHARMACEUTICAL SPECIALTIES, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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VANICREAM LIP PROTECTANT/SUNSCREEN
_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 on damaged or broken skin
WHEN USING THIS PRODUCT keep out of eyes. Rinse with water to remove.
STOP USE AND ASK A DOCTOR IF rash occurs
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,
steari