Sun Bum Skin Care Essentials Kit

Manufacturer
Sun Bum LLC
Effective date
2021-08-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:26

Label at a glance#

ProductSun Bum Skin Care Essentials Kit
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

helps prevent sunburn If used as directed with other sun protection measuress ( 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 a Broad Spectrum SPF value of 15 or higher and other sun...

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 measuress ( 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 if 

OTC - STOP USE SECTION

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

  • 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 a Broad Spectrum SPF value 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 (SPF 30 moisturizing sunscreen lotion)

INACTIVE INGREDIENT SECTION

water, polyglyceryl-6 stearate, dimethicone, cetearyl alcohol, capryloyl glycerin/sebacic acid copolymer, hydrated silica, hibiscus sabdariffa fruit extract, niacinamide, cocos nucifera (coconut) fruit extract, helianthus annuus (sunflower) extract, lactobacillus, lactobacillus ferment, musa sapientum (banana) flower extract, musa sapientum (banana) fruit extract, musa sapientum (banana) leaf extract, musa sapientum (banana) peel extract, musa sapientum (banana) pulp extract, lysolecithin, erythritol, glucose, glycerin, arachidyl alcohol, arachidyl glucoside, behenyl alcohol, cetearyl glucoside, fragrance, polyglyceryl-6 behenate, pullulan, sclerotium gum, tocopherol, xanthan gum, phenoxyethanol, ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

outer packageouter package
Inner PackageInner Package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-645-012025-01-30C16284748780-12cef2736-61c5-d83d-e063-dadaa90ab31fSun Bum Skin Care Essentials Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-645-01Sun Bum Skin Care Essentials Kit1 in 1 KITKIT11
69039-646-01Sun Bum Skin Care Essentials Kit15 mL in 1 TUBELOTION15 mL30 mg in 1mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-645SUN BUM SKIN CARE ESSENTIALS KIT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [SUN BUM LLC]1Legacy NDC, 2 package rows20210918_90574d55-4655-4902-b811-7523ace216d8.zip
69039-646SUN BUM SKIN CARE ESSENTIALS KIT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [SUN BUM LLC]1Unmatched20210918_90574d55-4655-4902-b811-7523ace216d8.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-64569039-645-01
69039-64669039-646-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 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
ca523d8d-78ba-40c7-e053-2995a90a86c790574d55-4655-4902-b811-7523ace216d82021-08-24WarningsExact identifier
spl id: ca523d8d-78ba-40c7-e053-2995a90a86c7
spl set id: 90574d55-4655-4902-b811-7523ace216d8

Reported adverse events (FAERS/openFDA)#

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