FDA.reportPublic FDA data

Sun Bum Face Mist SPF 45

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 23:48:03

Label at a glance#

ProductSun Bum Face Mist SPF 45
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

shake well 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 oth...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Homosalate 15.0%, Octisalate 5.0%, Octocrylene 7.0%.

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 externel 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well
  • 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 10a.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.
  • Do not store above 104°F /40°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol. denat. (67%), isoamyl cocoate, fragrance, hamamelis virginiana (witch hazel) bark/leaf extract, tocopherol

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:100ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box2Box2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-619-012025-01-30C16284748780-1d6a99b39-b481-a426-e053-dadaa90af4c2Sun Bum Face Mist SPF 45
69039-619-012022-02-04C16284748780-1d6a99b39-b481-a426-e053-dadaa90af4c2Sun Bum Face Mist SPF 45
69039-619-012022-01-28C16284748780-1d6a99b39-b481-a426-e053-dadaa90af4c2Sun Bum Face Mist SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-619-01Sun Bum Face Mist SPF 45100 mL in 1 BOTTLELIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-619SUN BUM FACE MIST SPF 45 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LIQUID [SUN BUM LLC]2Legacy NDC, 1 package rows20220205_b5f57f8e-7d51-3c0c-e053-2a95a90aa9ca.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-61969039-619-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ISOAMYL COCOATE14OG46E98EIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
TOCOPHEROLR0ZB2556P8IACT
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
d72f3561-be1c-7ef3-e053-2995a90a1bc0b5f57f8e-7d51-3c0c-e053-2a95a90aa9ca2022-02-04WarningsExact identifier
spl id: d72f3561-be1c-7ef3-e053-2995a90a1bc0
spl set id: b5f57f8e-7d51-3c0c-e053-2a95a90aa9ca

Reported adverse events (FAERS/openFDA)#

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