FDA.reportPublic FDA data

Vivier Sheer SPF 45

Manufacturer
Vivier Pharma, Inc.
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:21

Label at a glance#

ProductVivier Sheer SPF 45
Active ingredientZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE
Label structure9 sections

Indications and 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

Dosage and administration

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 pro...

Label contents#

Full prescribing information#

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

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


Purpose

OTC - PURPOSE SECTION

Sun Protectant

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on broken skin.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1 877 484 8437

Package Labeling:90ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3

Package Labeling:250ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package4Outer Package4Inner Package4Inner Package4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67226-2852-0Vivier Sheer SPF 451 in 1 CARTONLOTION13
67226-2852-0Vivier Sheer SPF 4590 mL in 1 TUBELOTION903
67226-2852-1Vivier Sheer SPF 451 in 1 CARTONLOTION13
67226-2852-1Vivier Sheer SPF 45250 mL in 1 TUBELOTION2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2852VIVIER SHEER SPF 45 (ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATE) LOTION [VIVIER PHARMA, INC.]3Current NDC, Legacy NDC, 4 package rows20231030_c057138a-1111-4e7c-b94d-2ccd6bc3963c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-285267226-2852-0, 67226-2852-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCOSANOL9G1OE216XYIACT
BUTYLPARABEN3QPI1U3FV8IACT
SHEA BUTTERK49155WL9YIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT
ETHYLPARABEN14255EXE39IACT
METHYLPARABENA2I8C7HI9TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
PROPYLPARABENZ8IX2SC1OHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
EDETATE SODIUMMP1J8420LUIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
ZINC OXIDESOI2LOH54ZACTIM
OCTOCRYLENE5A68WGF6WMACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vivier Sheer SPF 45ZINC OXIDE, OCTOCRYLENE, OCTINOXATE, OCTISALATEVivier Pharma, Inc.c057138a-1111-4e7c-b94d-2ccd6bc3963c2023-10-27WarningsExact identifier
ndc (package): 67226-2852-1
ndc (package): 67226-2852-0
ndc (product): 67226-2852
ndc11 (package): 67226285201
ndc11 (package): 67226285200
spl id: 08bf32be-a1ca-0c37-e063-6294a90a5c9b
spl set id: c057138a-1111-4e7c-b94d-2ccd6bc3963c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.