FDA.reportPublic FDA data

Vivier Sheer SPF 30 Mineral

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 23:58:11

Label at a glance#

ProductVivier Sheer SPF 30 Mineral
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure8 sections

Indications and uses

• Helps prevent sunburn • Sun Protection Factor 30 • 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 • 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, especi...

Label contents#

Full prescribing information#

Active ingredients (w/w)

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5% Avobenzone 2.5%

Ensulizole 2%

Purpose

OTC - PURPOSE SECTION

Sun Protectant

Uses

INDICATIONS & USAGE SECTION

• Helps prevent sunburn • Sun Protection Factor 30 • 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 • 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

Butylated Hydroxytoluene, Butylparaben, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, D-Panthenol, Ethylparaben, Hydrogenated Palm Glycerides, Methylparaben, Octyldodecanol, Octyldodecyl Neopentanoate, Phenoxyethanol, Potassium Cetyl Phosphate, Propylene Glycol, Propylparaben, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water.

Questions?

OTC - QUESTIONS SECTION

1 877 484 8437

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IPIP

OPVSMOPVSM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67226-2850-0Vivier Sheer SPF 30 Mineral1 in 1 CARTONLOTION13
67226-2850-0Vivier Sheer SPF 30 Mineral60 mL in 1 TUBELOTION603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2850VIVIER SHEER SPF 30 MINERAL (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [VIVIER PHARMA, INC.]3Current NDC, Legacy NDC, 2 package rows20231030_1be5ee36-3566-495c-aae2-4d0d7fc210ed.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-285067226-2850-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
DIPROPYLENE GLYCOL DIBENZOATE6OA5ZDY41OIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYL BENZOATEJ115BRJ15HIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
POLYSORBATE 207T1F30V5YHIACT
PROPYLPARABENZ8IX2SC1OHIACT
APPLEB423VGH5S9IACT
SUGARCANE81H2R5AOH3IACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
XANTHAN GUMTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
ALUMINUM OXIDELMI26O6933IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
BIS-PEG/PPG-16/16 PEG/PPG-16/16 DIMETHICONE55A74AJ3KBIACT
BUTYLPARABEN3QPI1U3FV8IACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ORANGE PEELTI9T76XD44IACT
LEMON PEEL72O054U628IACT
CYCLOMETHICONE 6XHK3U310BAIACT
CYCLOMETHICONE 50THT5PCI0RIACT

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 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.1be5ee36-3566-495c-aae2-4d0d7fc210ed2023-10-27WarningsExact identifier
ndc (package): 67226-2850-0
ndc (product): 67226-2850
ndc11 (package): 67226285000
spl id: 08bf29ff-1c49-1547-e063-6294a90ac7ee
spl set id: 1be5ee36-3566-495c-aae2-4d0d7fc210ed

Reported adverse events (FAERS/openFDA)#

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