VIVIER SHEER SPF 45- zinc oxide, octocrylene, octinoxate, octisalate lotion 
Vivier Pharma, Inc.

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Vivier Sheer SPF 45

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

Outer Package3Inner Package3

Package Labeling:250ml

Outer Package4Inner Package4

VIVIER SHEER SPF 45 
zinc oxide, octocrylene, octinoxate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-2852
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION99 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67226-2852-01 in 1 CARTON01/05/2023
190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:67226-2852-11 in 1 CARTON01/05/2023
2250 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/05/2023
Labeler - Vivier Pharma, Inc. (250996550)

Revised: 10/2023
Document Id: 08bf32be-a1ca-0c37-e063-6294a90a5c9b
Set id: c057138a-1111-4e7c-b94d-2ccd6bc3963c
Version: 3
Effective Time: 20231027
 
Vivier Pharma, Inc.