SHEER BROAD SPECTRUM SPF45- zinc oxide, octocrylene, octinoxate, octisalate lotion

Sheer Broad Spectrum SPF45 by

Drug Labeling and Warnings

Sheer Broad Spectrum SPF45 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

9.9% Zinc Oxide
8.0% Octocrylene
7.5% Ethylhexyl Methoxycinnamate
5.0% Ethylhexyl Salicylate

PURPOSE

Sunscreen

USES

Helps prevent sunburn and provides a sun protection factor of 45.
Ideal for daily use; can be applied under makeup.

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.

STORAGE AND HANDLING

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

INACTIVE INGREDIENTS

BEHENYL ALCOHOL, BUTYLPARABEN, BUTYROSPERMUM PARKII, C12-15 ALKYL BENZOATE, CETEARETH-20, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOTETRASILOXANE, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, PHENYL TRIMETHICONE, PROPYLPARABEN, SILICA, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU.

Questions?

450 455 9779                           1 877 484 8437

Product Labels

INGREDIENTS AND APPEARANCE

SHEER BROAD SPECTRUM SPF45 
zinc oxide, octocrylene, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2845
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	99 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2845-9	1 in 1 CARTON	05/14/2015
1		90 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 67226-2845-2	250 mL in 1 TUBE; Type 0: Not a Combination Product	05/14/2015	06/01/2017
3	NDC: 67226-2845-4	1 in 1 CARTON	05/14/2015
3		4 mL in 1 TUBE; 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	05/14/2015

Labeler - Vivier Pharma Inc. (250996550)