VANICREAM SUNSCREEN BROAD SPECTRUM SPF 35- octinoxate and zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Pharmaceutical Specialties, Inc.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 0.028 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 35- OCTINOXATE 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._
----------
VANICREAM SUNSCREEN SPORT BROAD SPECTRUM SPF 35
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Octinoxate 2.8%
Zinc Oxide 11%
_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, cetyl PEG/PPG-10/1
dimethicone,
cyclohexasiloxane, cyclopentasiloxane, cyclotetrasiloxane,
dimethiconol, glycerin,
hydrogenated castor oil, magnesium chloride, PEG-30
dipolyhydroxystearate, polypropyl
silsesquioxane, purified water, tridecyl neopentanoate,
triethoxycaprylylsilane,
trimethylsiloxy silicate, ubiquinone (coenzyme Q10)
_QUESTIONS OR COMMENTS? _800-325-8232
www.vanicream.com Official Vanicream
PHARMACEUTlCAL SPEC