FDA.reportPublic FDA data

Sun Bum Premium Moisturizing Sunscreen Roll On Lotion SPF 50

Manufacturer
Sun Bum LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:16

Label at a glance#

ProductSun Bum Premium Moisturizing Sunscreen Roll On SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 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

• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: 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 Br...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalte 10%
Octisalate 5%,  Octocrylene 10%

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 if

OTC - STOP USE SECTION

rash occurs

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before use • apply liberally and spread by hand15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: 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 value 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-sleeved shirts, pants, hats and sunglasses

Other information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, polyglyceryl-6 stearate, styrene/acrylates copolymer, acrylates/c 12-22 alkyl methacrylate copolymer, polyster-8, tocopheryl acetate, lysolecithin, sclerotium gum, tetrasodium glutamate diacetate, pullulan, xanthan gum, polyglyceryl-6 behenate, citric acid, phenoxyethanol, ethylhexylglycerin, fragrance

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-642-012025-01-30C16284748780-12cef2736-a330-d83d-e063-dadaa90ab31fSun Bum Premium Moisturizing Sunscreen Roll On Lotion SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-642-01Sun Bum Premium Moisturizing Sunscreen Roll On SPF 5088 mL in 1 TUBELOTION882

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-642SUN BUM PREMIUM MOISTURIZING SUNSCREEN ROLL ON SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SUN BUM LLC]2Legacy NDC, 1 package rows20220216_8d6c912e-9373-4852-8523-ee7e16f94b8c.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-64269039-642-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
BETASIZOFIRAN2X51AD1X3TIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
PULLULAN8ZQ0AYU1TTIACT
XANTHAN GUMTTV12P4NEEIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT

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
d73e6c85-e9bd-02c1-e053-2995a90ad4468d6c912e-9373-4852-8523-ee7e16f94b8c2022-02-04WarningsExact identifier
spl id: d73e6c85-e9bd-02c1-e053-2995a90ad446
spl set id: 8d6c912e-9373-4852-8523-ee7e16f94b8c

Reported adverse events (FAERS/openFDA)#

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