TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30 SPF 30

Dosage form: lotion
Ingredients: TITANIUM DIOXIDE 100mg in 1mL, ZINC OXIDE 80mg in 1mL
Labeler: VIVIER PHARMA INC
NDC Code: 67226-2230

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.

TRIPLE PROTECTION BROAD SPECTRUM SUNSCREEN

Active ingredients

Titanium Dioxide 10%

Zinc Oxide 10%

Purpose

Sunscreen

Use■ 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 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




TRIPLE PROTECTION BROAD SPECTRUM SUNSCREENSPF 30   SPF 30
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2230
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE100 mg  in 1 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:67226-2230-61 BOTTLE (BOTTLE) in 1 BOX
160 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/24/2010
Labeler - VIVIER PHARMA INC (250996550)

Revised: 12/2012
 
VIVIER PHARMA INC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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