VIVIER SHEER SPF 45- zinc oxide, octocrylene, octinoxate, octisalate lotion

Vivier Sheer SPF 45 by

Drug Labeling and Warnings

Vivier Sheer SPF 45 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 (w/w)

Zinc Oxide 9.9% Octocrylene 8% Octinoxate 7.5% Octisalate 5%

Purpose

Sun Protectant

Uses

 Helps prevent sunburn Sun Protection Factor 45 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 broken skin.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

rash occurs.

Keep out of reach of children.

If swallowed, call a poison control centre or get medical help right away.

Directions

Adults and children over 6 months of age: Apply liberally and evenly 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.; and wear long-sleeved shirts, pants, hats, and sunglasses.

Other information

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

Inactive ingredients

Behenyl Alcohol, Butylparaben, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Ceteareth-20, Cetearyl Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Ethylparaben, Methylparaben, Phenoxyethanol, Phenyl Trimethicone, Propylparaben, Silica, Tetrasodium EDTA, Tocopherol,  Triethoxycaprylylsilane, Water.

Questions?

1 877 484 8437

Package Labeling:90ml

Package Labeling:250ml

INGREDIENTS AND APPEARANCE

VIVIER SHEER SPF 45 
zinc oxide, octocrylene, octinoxate, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67226-2852
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
DOCOSANOL (UNII: 9G1OE216XY)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
SHEA BUTTER (UNII: K49155WL9Y)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67226-2852-0	1 in 1 CARTON	01/05/2023
1		90 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67226-2852-1	1 in 1 CARTON	01/05/2023
2		250 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 Drug	M020	01/05/2023

Labeler - Vivier Pharma, Inc. (250996550)