FDA.reportPublic FDA data

bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free

Manufacturer
Bu Brands, LLC | Westwood Laboratories, Inc.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:26:32

Label at a glance#

Productbu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free
Active ingredientOCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure11 sections

Indications and uses

helps prevent sunburn 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

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Do not spray directly onto the face. Spray into hands, and apply to the face. children under 6 months: Ask a doctor 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...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate (7.500%)
Octocrylene (7.500%)
Octisalate (5.00%)
Avobenzone (2.500%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • 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 damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not usenear flame or while smoking

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Do not spray directly onto the face. Spray into hands, and apply to the face.
  • children under 6 months: Ask a doctor
  • 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 of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Diphenylsiloxy Phenyl Trimethicone, VP/Hexadecene Copolymer, Polybutene, Octyldodecanol, Tocopherols, Bisabolol.

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

Manufactured by Cosmaceuticals,Surrey, BC, V3W 1K7

PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF30
broad
spectrum

spray-on
alcohol-free
performance
sunscreen

Oil-Free
Preservative-Free

with Antioxidants
Fragrance-Free

bü

Water Resistant (80 Minutes)
3.3oz (98mL)

PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 98 mL Bottle Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70325-3001-1bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free30 mL in 1 BOTTLE, PLASTICSPRAY306
70325-3001-3bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance Free98 mL in 1 BOTTLE, SPRAYSPRAY986

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70325-3001BU SPF 30 BROAD SPECTRUM ON ALCOHOL-FREE PERFORMANCE SUNSCREEN - FRAGRANCE FREE (OCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) SPRAY [BU BRANDS, LLC]6Current NDC, Legacy NDC, 2 package rows20241019_20b32aae-7f8b-44ed-a3df-706054fd6883.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70325-300170325-3001-3, 70325-3001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYCLOMETHICONE 50THT5PCI0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIPHENYLSILOXY PHENYL TRIMETHICONEI445L28B12IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML · Source PDF

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
bu SPF 30 Broad Spectrum on Alcohol-Free Performance Sunscreen - Fragrance FreeOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC20b32aae-7f8b-44ed-a3df-706054fd68832024-10-17WarningsExact identifier
ndc (package): 70325-3001-1
ndc (package): 70325-3001-3
ndc (product): 70325-3001
ndc11 (package): 70325300103
ndc11 (package): 70325300101
spl id: 24b2d673-9303-c6a6-e063-6394a90ac7b9
spl set id: 20b32aae-7f8b-44ed-a3df-706054fd6883

Reported adverse events (FAERS/openFDA)#

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