TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30 description, usages, side effects, indications, overdosage, supplying and lots more!

TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30

VIVIER PHARMA INC

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
TRIPLE PROTECTION BROAD SPECTRUM SUNSCREEN

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Titanium Dioxide 10%

Zinc Oxide 10%

Purpose

Sunscreen

Use




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 at least every 2 hours
■ Use a water resistant sunscreen if swimming or sweating
■ 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
■ Children under 6 months of age: Ask a doctor

Other Information

■ Protect the product in this container from excessive heat
and direct sun

Inactive ingredients

INACTIVE INGREDIENTS: ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS-PEG/PPG-16/16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, CAMELLIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/
CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, C12-15 ALKYL BENZOATE,
DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE/TRIETHOXYCAPRYLYL CROSSPOLYMER, METHYLPARABEN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYSORBATE 20, PPG-15 STEARYL
ETHER BENZOATE, PROPYLPARABEN, PYRUS MALUS (APPLE) FRUIT EXTRACT, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, WATER/EAU, XANTHAN GUM.

Questions?

(450) 455-9779; 1 (877) 484-8437

Package Label

NDC 67226-2230-6

Vivierskin®

TRIPLE PROTECTION
BROAD SPECTRUM
SPF 30 SUNSCREEN

WITH ANTIOXIDANTS,
ZINC AND TITANIUM

2 fl oz (60 mL)

INDICATION
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.
DIRECTIONS
For sunscreen use, apply liberally 15 minutes before sun exposure. Reapply at least every
2 hours. Use a water resistant sunscreen if swimming or sweating. 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.
Children under 6 months of age: Ask a doctor.
PRECAUTIONS
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
Poison Control Center right away.

ACTIVE INGREDIENTS (w/w)
■ 10% Titanium Dioxide ■ 8% Zinc Oxide

Vivier Canada Inc.
Mfd. for Vivier Pharma
Hudson QC Canada J0P 1H0
Champlain NY 12919

Made in Canada
® Vivier Canada Inc. – used under license
vivierpharma.com



Package Label

Package Label


TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30

TITANIUM DIOXIDE, ZINC OXIDE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:67226-2230
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
titanium dioxide 100 mg
Zinc Oxide Zinc oxide 80 mg

Inactive Ingredients

Ingredient Name Strength
ALUMINUM OXIDE
BUTYLPARABEN
GREEN TEA LEAF
MEDIUM-CHAIN TRIGLYCERIDES
CETOSTEARYL ALCOHOL
DIMETHICONE
LEMON
cyclomethicone
C12-15 ALKYL BENZOATE
DIMETHICONE
DIPROPYLENE GLYCOL
ETHYLPARABEN
GLYCERIN
GLYCERYL MONOSTEARATE
METHYLPARABEN
PHENOXYETHANOL
POLYSORBATE 20
PROPYLPARABEN
APPLE
SODIUM ASCORBYL PHOSPHATE
.ALPHA.-TOCOPHEROL ACETATE, D-
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 BOTTLE
2 NDC:67226-2230-6 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-11-24


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