FDA.reportPublic FDA data

Sun Bum Hand Cream SPF15

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 23:48:05

Label at a glance#

ProductSun Bum Hand Cream SPF15
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

helps prevent sunburn Keep outer carton for full information 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 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...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%,

Homosalate 5%,

Octisalate 2%,

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • Keep outer carton for full information
  • 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

  • apply liberally 15 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, isoamyl cocoate, cetearyl alcohol, arachidyl alcohol, dimethicone, glycerin, behenyl alcohol, styrene/acrylates copolymer, cetearyl glucoside, arachidyl glucoside, fragrance, polyester-8, saccharide isomerate, aprylyl glycol, phenoxyethanol, sorbic acid, xanthan gum xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package 3Outer Package 3Inner Package3.jpgInner Package3.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-637-012025-01-30C16284748780-12cef2736-aee7-d83d-e063-dadaa90ab31fSun Bum Hand Cream SPF15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-637-01Sun Bum Hand Cream SPF1559 mL in 1 CARTONCREAM592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-637SUN BUM HAND CREAM SPF15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [SUN BUM LLC]2Legacy NDC, 1 package rows20220205_c2afec94-0996-a349-e053-2a95a90a8c41.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-63769039-637-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ISOAMYL COCOATE14OG46E98EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
DOCOSANOL9G1OE216XYIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBIC ACIDX045WJ989BIACT
XANTHAN GUMTTV12P4NEEIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
d72ec72a-41d9-02c4-e053-2995a90a64c4c2afec94-0996-a349-e053-2a95a90a8c412022-02-04WarningsExact identifier
spl id: d72ec72a-41d9-02c4-e053-2995a90a64c4
spl set id: c2afec94-0996-a349-e053-2a95a90a8c41

Reported adverse events (FAERS/openFDA)#

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