FDA.reportPublic FDA data

Sunscreen SPF 50

Manufacturer
Sun Bum | Product Quest Mfg
Effective date
2017-05-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:33

Label at a glance#

ProductSunscreen SPF 50 Sun Bum
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure7 sections

Label contents#

Full prescribing information#

Active ingredients                                                                                            Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%     Sunscreen

INDICATIONS & USAGE SECTION

Uses • helps prevent sunburn• If used as directed with other sun protection measures (see Directions), decreases the rick of skin cancer and early skin aging caused by the sun

WARNINGS SECTION

Warnings
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor 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

DOSAGE & ADMINISTRATION SECTION

Directions
• 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 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
• children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water
Butyloctyl Salicylate
Hydrated Silica
VP/Hexadecene Copolymer
Styrene/Acrylates Copolymer
Dimethicone
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130871760001947GTIN-13: 0871760001947
EAN-13: 0871760001947
GTIN-12: 871760001947
UPC-A: 871760001947
GTIN storage (14 digits): 00871760001947		back.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-564-062020-02-27C16284748780-19d75b9cf-d394-f424-e053-dadaa90a57ceDrug Facts
69039-564-062020-01-31C16284748780-19d75b9cf-d394-f424-e053-dadaa90a57ceDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-56469039-564-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Hydrated SilicaY6O7T4G8P9IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
Dimethicone92RU3N3Y1OIACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
Ethylhexyl StearateEG3PA2K3K5IACT
Trideceth-63T5PCR2H0CIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
Dimethyl CapramideO29Y6X2JEZIACT
Ethylhexylglycerin147D247K3PIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0)25LXE464L2IACT
Xanthan GumTTV12P4NEEIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM7FLD91C86KIACT
Methylisothiazolinone229D0E1QFAIACT

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
9f929ced-a035-dab7-e053-2a95a90a235997159f50-527d-4bbc-a54a-92ff4e7c43c52020-02-27WarningsExact identifier
spl set id: 97159f50-527d-4bbc-a54a-92ff4e7c43c5

Reported adverse events (FAERS/openFDA)#

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