FDA.reportPublic FDA data

Sun Bum Kids Face SPF 50

Manufacturer
Sun Bum LLC
Effective date
2022-08-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:50:35

Label at a glance#

ProductSun Bum Kids Face SPF 50
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 value of 15 or higher and...

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 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

INACTIVE INGREDIENT SECTION

octyldodecanol, caprylic/capric triglyceride, butyloctyl salicylate, dibutyl ethylhexanoyl glutamide, dibutyl lauroyl glutamide, trimethylentanediol/ adipic acid/glycerin crosspolymer, tocopheryl acetate, fragrance, pongamol

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label06Label06Label07Label07

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-237-012025-01-30C16284748780-12cef2736-6b5e-d83d-e063-dadaa90ab31fSun Bum Kids Face Stick SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-237-01Sun Bum Kids Face SPF 501 in 1 CARTONSTICK12
69039-237-01Sun Bum Kids Face SPF 5015 g in 1 TUBESTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-237SUN BUM KIDS FACE SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [SUN BUM LLC]2Legacy NDC, 2 package rows20220901_90ae5bb0-d199-485e-9d36-c3db28289357.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-23769039-237-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECANOL461N1O614YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
ADIPIC ACID76A0JE0FKJIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PONGAMOL8Y19QCY6I4IACT
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
e684ef19-5456-f816-e053-2995a90a3ffb90ae5bb0-d199-485e-9d36-c3db282893572022-08-18WarningsExact identifier
spl id: e684ef19-5456-f816-e053-2995a90a3ffb
spl set id: 90ae5bb0-d199-485e-9d36-c3db28289357

Reported adverse events (FAERS/openFDA)#

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