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Name:Vivierskin Sunshieldspf 45
Manufacturer:Vivier Pharma, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


VivierSkin Sunshield SPF45

VIVIERSKIN SUNSHIELD SPF 45 - zinc oxide, titanium dioxide and octinoxate cream 
Vivier Pharma, 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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VivierSkin Sunshield SPF45

Active Ingredients

4.8% Zinc Oxide
7.8% Titanium Dioxide
7.5% Parsol MCX* (Octinoxate)

Purpose

Sunscreen

Uses

Provides a sun protection factor of 45.
Provides broad spectrum UVA/UVB protection.
Ideal for daily use; can be applied under makeup.
The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

Warnings

For external use only

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash or irritation develops.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply daily to face, neck and chest.
Apply liberally and evenly 15 to 30 minutes prior to sun exposure and as needed.
Reapply as needed or after swimming, towel drying, perspiring heavily or washing.
For use on children under 6 months of age, consult a physician.

Inactive Ingredients

Water/Eau, C12-C15 Alkyl Benzoate, Alumina, Methicone, Polyhydroxystearic Acid, Triethoxy Caprylylsilane, Cyclomethicone, Dimethicone Copolyol, Cetyl Dimethicone, PEG 150, Decyl Alcohol, SMDI Copolymer, Sodium Chloride, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions

450 455 9779                      1 877 484 8437

Store at room temperature (15-30°C / 59-86°F).
Oil free. Alcohol-free. Fragrance-free.

Mfd. for Vivier Pharma
Hudson, QC, Canada J0P 1H0
Champlain NY 12919
Made in Canada
Prod. #80040 07-8040-10
www.vivierpharma.com

NDC 67226-2045-1


Sunshield
SPF45

Superior daily
protection for the face
Broad spectrum UVA/UVB
Zinc Oxide

NET WT. 100 mL / 3.4 fl. oz.

CREAM


Sunshield 45

Sunshield 45


VIVIERSKIN SUNSHIELD  SPF 45
zinc oxide, titanium dioxide, octinoxate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2045
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 4.8 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 7.5 mL  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ALKYL (C12-15) BENZOATE  
ALUMINUM OXIDE  
POLYHYDROXYSTEARIC ACID (2300 MW)  
TRIETHOXYCAPRYLYLSILANE  
CYCLOMETHICONE  
DIMETHICONE  
DIMETHICONE  
POLYETHYLENE GLYCOL 6000  
1-DECANOL  
SODIUM CHLORIDE  
DMDM HYDANTOIN  
IODOPROPYNYL BUTYLCARBAMATE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67226-2045-1 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE
1 100 mL in 1 BOTTLE This package is contained within the BOX (67226-2045-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/25/2011

Labeler - Vivier Pharma, Inc. (250996550)

Revised: 03/2011 Vivier Pharma, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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