FDA.reportPublic FDA data

Baby Bum Mineral SPF50 Sunscreen

Manufacturer
Sun Bum LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:48:00

Label at a glance#

ProductBaby Bum Mineral SPF50 Sunscreen
Active ingredientZINC 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 • 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 ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 19.2%

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

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

• 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 • keep this outer card for complete labeling information

Inactive ingredients

INACTIVE INGREDIENT SECTION

cocos nucifera (coconut) oil, persea gratissima (avocado) oil, limnanthes alba (meadowfoam) seed oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, euphorbia cerifera (candelilla) wax, butyloctyl salicylate, copernicia cerifera (carnauba) wax, ozokerite, butyrospermum parkii (shea butter), oryzanol, fragrance, theobroma cacao (cocoa) seed butter, carthamus tinctorius (safflower) seed oil, jojoba esters, tocopherol, bisabolol

Questions?

OTC - QUESTIONS SECTION

call 1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package frontOuter Package frontOuter Package backOuter Package backInner PackageInner Package

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-271-002024-01-30C16284748780-1d6a99b39-35c6-a426-e053-dadaa90af4c2Baby Bum Mineral SPF50 Sunscreen Face Stick
69039-271-002022-02-04C16284748780-1d6a99b39-35c6-a426-e053-dadaa90af4c2Baby Bum Mineral SPF50 Sunscreen Face Stick
69039-271-002022-01-28C16284748780-1d6a99b39-35c6-a426-e053-dadaa90af4c2Baby Bum Mineral SPF50 Sunscreen Face Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-271-00Baby Bum Mineral SPF50 Sunscreen13 g in 1 TUBESTICK135
69039-271-00Baby Bum Mineral SPF50 Sunscreen1 in 1 CARTONSTICK15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-271BABY BUM MINERAL SPF50 SUNSCREEN (ZINC OXIDE) STICK [SUN BUM LLC]5Legacy NDC, 2 package rows20220205_492c44e3-4369-4367-939b-def1fd87de01.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-27169039-271-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCONUT OILQ9L0O73W7LIACT
AVOCADO OIL6VNO72PFC1IACT
MEADOWFOAM SEED OIL412ZHA4T4YIACT
LINSEED OIL84XB4DV00WIACT
RICE BRANR60QEP13ICIACT
CANDELILLA WAXWL0328HX19IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CARNAUBA WAXR12CBM0EIZIACT
CERESINQ1LS2UJO3AIACT
SHEA BUTTERK49155WL9YIACT
GAMMA ORYZANOLSST9XCL51MIACT
COCOA BUTTER512OYT1CRRIACT
SAFFLOWER OIL65UEH262ISIACT
TOCOPHEROLR0ZB2556P8IACT
LEVOMENOL24WE03BX2TIACT
ZINC OXIDESOI2LOH54ZACTIM

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
d72ddd27-98bc-df90-e053-2a95a90a1241492c44e3-4369-4367-939b-def1fd87de012022-02-04WarningsExact identifier
spl id: d72ddd27-98bc-df90-e053-2a95a90a1241
spl set id: 492c44e3-4369-4367-939b-def1fd87de01

Reported adverse events (FAERS/openFDA)#

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