FDA.reportPublic FDA data

SUN BUM SPF 15 PREMIUM MOISTURIZING SUNSCREEN

Manufacturer
Sun Bum, LLC.
Effective date
2022-02-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:34

Label at a glance#

ProductSUN BUM SPF 15 PREMIUM MOISTURIZING SUNSCREEN
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

• Helps prevent sunburn • higher SPF gives more sunburn protection • Ifusedasdirectedwithothersunprotectionmeasures(seeDirections), decreasestheriskofskincancerandearlyskinagingcausedbythesun

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. • 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including: • Limit tim...

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 • higher SPF gives more sunburn protection • Ifusedasdirectedwithothersunprotectionmeasures(seeDirections), decreasestheriskofskincancerandearlyskinagingcausedbythesun

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.
• 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including:
• Limit time in the sun, especially from 10 am - 2 pm.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

Otherinformation

SPL UNCLASSIFIED SECTION

protectthis product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, butyloctylsalicylate, hydratedsilica, styrene/acrylatescopolymer, dimethicone, VP/hexadecene copolymer, polyester-8, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-212-032025-01-30C16284748780-12cef2736-9e11-d83d-e063-dadaa90ab31fSUN BUM SPF 15 PREMIUM MOISTURIZING SUNSCREEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-212-03SUN BUM SPF 15 PREMIUM MOISTURIZING SUNSCREEN3780 mL in 1 BOTTLELOTION37801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-212SUN BUM SPF 15 PREMIUM MOISTURIZING SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [SUN BUM, LLC.]1Legacy NDC, 1 package rows20220301_d912d9ba-0203-05f6-e053-2995a90a58d1.zip

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
69039-21269039-212-03

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
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HYDRATED SILICAY6O7T4G8P9IACT
STYRENE44LJ2U959VIACT
DIMETHICONE92RU3N3Y1OIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
TRIDECETH-63T5PCR2H0CIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYETHYLENE GLYCOL 4500TVH7653921IACT
DOCOSANOL9G1OE216XYIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
POLYAMINOPROPYL BIGUANIDEDT9D8Z79ETIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
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
d912dabd-2535-7b4e-e053-2995a90ae323d912d9ba-0203-05f6-e053-2995a90a58d12022-02-28WarningsExact identifier
spl id: d912dabd-2535-7b4e-e053-2995a90ae323
spl set id: d912d9ba-0203-05f6-e053-2995a90a58d1

Reported adverse events (FAERS/openFDA)#

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