TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide cream

Triple Protection Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Triple Protection Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Vivier Pharma Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

ACTIVE INGREDIENTS

Titanium Dioxide 10.0%
Zinc Oxide 8.0%

PURPOSE

Sunscreen

USES

• Helps prevent sunburn and provides a sun protection factor of 30.
• Ideal for daily use; can be applied under makeup.

WARNINGS

For external use only

• 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.​

When using this product

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Do not use on damaged or broken skin.

Stop use and ask a doctor if

• Rash or irritation develops and lasts.

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 minutes before sun exposure.
• Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
• For use on children less than 6 months of age, consult a healthcare practitioner.
• Use a water resistant sunscreen if swimming or sweating.

INACTIVE INGREDIENTS:

ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS PEG/PPG-16-16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, C12-15 ALKYL
BENZOATE, CAMELIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/- CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL
DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE, 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, TRIETHOXYCAPRYLYLSILANE, WATER/EAU, XANTHAN GUM.

Questions?

450 455 9779 1 877 484 8437

Package Labeling:

INGREDIENTS AND APPEARANCE

TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2231
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	100 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
LEMON PEEL (UNII: 72O054U628)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
APPLE (UNII: B423VGH5S9)
SUGARCANE (UNII: 81H2R5AOH3)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2231-6	1 in 1 CARTON	11/11/2017
1		60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/11/2017

Labeler - Vivier Pharma Inc (250996550)