FDA.reportPublic FDA data

Sun Bum Premium Sunscreen Face Broad Spectrum SPF 30

Manufacturer
Sun bum LLC
Effective date
2019-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:34:22

Label at a glance#

ProductSun Bum Premium Sunscreen Face Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE
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

• 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:  ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.00%, Homosalate 15.00%,

Octinoxate 7.50%, Octisalate 5.00%

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

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 a 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-sleeve shirts, pants, hats, and sunglasses.

• Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ascorbyl Palmitate, Beeswax, BHT, Cetyl Alcohol, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Ozokerite, Paraffin, Polyester-8, Polyethylene, Tocopheryl Acetate.

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

  • Call +1 (877) 978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label1Label1Inner1Inner1

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-20769039-207-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBYL PALMITATEQN83US2B0NIACT
YELLOW WAX2ZA36H0S2VIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETYL ALCOHOL936JST6JCNIACT
ETHYLHEXYL PALMITATE2865993309IACT
CANDELILLA WAXWL0328HX19IACT
PARAFFINI9O0E3H2ZEIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB

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
d76593c3-0e46-d2c3-e053-2995a90adeffd68d7824-9cd4-4ad0-8bf7-50352598b0d72022-02-06WarningsExact identifier
spl set id: d68d7824-9cd4-4ad0-8bf7-50352598b0d7

Reported adverse events (FAERS/openFDA)#

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