FDA.reportPublic FDA data

Sun Bum Face 50 Sunscreen Lotion

Manufacturer
SUN BUM, LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:47:59

Label at a glance#

ProductSun Bum Face 50 Sunscreen
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

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 of 15 or higher and other sun p...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3 %, Homosalate 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

OTC - STOP USE SECTION

if 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 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.

Other Information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, hydrated silica, VP/hexadecene copolymer, styrene/acrylates copolymer, dimethicone, polyester-8, tocopherol acetate, BHT, glyceryl stearate, PEG-100 stearate, ethylhexyl stearate, behenyl alcohol, caprylyl methicone, trimethylsiloxysilicate, dimethyl capramide, sodium polyacrylate, xanthan gum, trideceth-6, disodium EDTA, ethylhexylglycerin, polyaminopropyl biguanide, methylisothiazolinone

Questions or Comments?

OTC - QUESTIONS SECTION

call +1 (877) 978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-250-002025-01-30C16284748780-1d6a99b39-3575-a426-e053-dadaa90af4c2Sun Bum Face 50 Sunscreen Lotion
69039-250-002022-02-04C16284748780-1d6a99b39-3575-a426-e053-dadaa90af4c2Sun Bum Face 50 Sunscreen Lotion
69039-250-002022-01-28C16284748780-1d6a99b39-3575-a426-e053-dadaa90af4c2Sun Bum Face 50 Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-250-00Sun Bum Face 50 Sunscreen88.7 mL in 1 TUBECREAM88.74

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-250SUN BUM FACE 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [SUN BUM, LLC]4Legacy NDC, 1 package rows20220205_4032e623-f958-4e7a-afa3-afc844c6b4e0.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-25069039-250-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HYDRATED SILICAY6O7T4G8P9IACT
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
DIMETHICONE92RU3N3Y1OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
DOCOSANOL9G1OE216XYIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
XANTHAN GUMTTV12P4NEEIACT
TRIDECETH-63T5PCR2H0CIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
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
d72e8d59-6a21-0574-e053-2995a90aadb84032e623-f958-4e7a-afa3-afc844c6b4e02022-02-04WarningsExact identifier
spl id: d72e8d59-6a21-0574-e053-2995a90aadb8
spl set id: 4032e623-f958-4e7a-afa3-afc844c6b4e0

Reported adverse events (FAERS/openFDA)#

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