Sun Bum Tinted Lip Balm Raisin Hell

Manufacturer
Sun Bum, LLC
Effective date
2019-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:34

Label at a glance#

ProductSun Bum Tinted Lip Balm Raisin Hell
Active ingredientHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
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 use a water resistant sunscreen if swimming or sweating 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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%, Octisalate 5%

Octocrylene 3%, Zinc Oxide 2.85%

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
  • use a water resistant sunscreen if swimming or sweating
  • 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

SPL UNCLASSIFIED SECTION

protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax, cocos nucifera (coconut) oil, ricinus communis (castor) seed oil, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, olea europaea (olive) fruit oil, theobroma grandiflorum seed butter, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, flavor, helianthus annuus (sunflower) seed oil, polyhydroxystearic acid, limnanthes alba (meadowfoam) seed oil, aloe barbadensis leaf extract, simmondsia chinensis (jojoba) seed oil, carthamus tinctorius (safflower) seed oil, tocopherol, jojoba esters, octyldodecyl oleate, stevia rebaudiana extract, indigofera tinctoria leaf extract, glycine soja (soybean) oil, silica, carmine, mica, iron oxide, tin oxide, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

call 1 (877) 978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-265-002022-02-06C16284748780-1d6a99b39-b907-a426-e053-dadaa90af4c2Sun Bum Tinted Lip Balm Raisin Hell
69039-265-002022-01-28C16284748780-1d6a99b39-b907-a426-e053-dadaa90af4c2Sun Bum Tinted Lip Balm Raisin Hell

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-26569039-265-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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
d765157c-8306-06be-e053-2a95a90aa5b9379a1aaf-0f4e-4e61-aad5-0604d483c2c42022-02-06WarningsExact identifier
spl set id: 379a1aaf-0f4e-4e61-aad5-0604d483c2c4

Reported adverse events (FAERS/openFDA)#

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