FDA.reportPublic FDA data

Sunscreen Lotion SPF 30

Manufacturer
Vivier Pharma, Inc.
Effective date
2024-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 21:15:48

Label at a glance#

ProductSunscreen SPF 30
Active ingredientOCTINOXATE, AVOBENZONE, ENSULIZOLE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply daily to face, neck and chest. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. For use on children less than 6 months of age, consult a healthcare practitioner. 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 suns...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5% Avobenzone 2.5%  Ensulizole 2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or 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 or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply daily to face, neck and chest.
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • For use on children less than 6 months of age, consult a healthcare practitioner.
  • 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. to 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

Call 1 877 484 8437

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-203167226-2031-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
BUTYLPARABEN3QPI1U3FV8IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
DEXPANTHENOL1O6C93RI7ZIACT
ETHYLPARABEN14255EXE39IACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
METHYLPARABENA2I8C7HI9TIACT
OCTYLDODECANOL461N1O614YIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
ENSULIZOLE9YQ9DI1W42ACTIB

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
472c5f95-d42b-a21c-e063-6294a90a9ea11435d7f2-3d29-45e2-8b8f-74a0ea7ee9fa2025-12-30WarningsExact identifier
spl set id: 1435d7f2-3d29-45e2-8b8f-74a0ea7ee9fa

Reported adverse events (FAERS/openFDA)#

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