VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- titanium dioxide and zinc oxide cream

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 OXIDE - UNII:SOI2LOH54Z)

Available from:

Pharmaceutical Specialties, Inc.

INN (International Name):

TITANIUM DIOXIDE

Composition:

TITANIUM DIOXIDE 0.05 g in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose 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

Authorization status:

OTC monograph final

Summary of Product characteristics

VANICREAM SUNSCREEN BROAD SPECTRUM SPF 50 PLUS- TITANIUM DIOXIDE AND
ZINC
OXIDE CREAM
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 SUNSCREEN BROAD SPECTRUM SPF 50+
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Titanium dioxide 5%
Zinc oxide 7%
_PURPOSE_
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
_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 _C20-40 alcohols, caprylyl glycol, cetyl
PEG/PPG-10/1 dimethicone,
cocoglycerides, dicaprylyl carbonate, dimethicone, 1,2 hexanediol,
hydrogenated castor oil,
hydrogenated polyisobutene, magnesium chloride, octadecene, PEG-30
dipolyhydroxystearate,
pentylene glycol, phenyl trimethicone, purified water, silica, silica
dimethyl silylate, squalane, stearyl
dimethicone, tridecyl salicylate, triethoxycaprylylsilane, ubiquinone
(coenzyme Q1