Baby Bum Mineral 50 Sunscreen

Manufacturer
Sun Bum, LLC
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:23

Label at a glance#

ProductBaby Bum Mineral 50 Sunscreen Roll-On
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure12 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 before use • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly onto face. Spray on hands then apply to face. • 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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide – 3.4%, Zinc Oxide - 16%

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 on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children

Directions

INSTRUCTIONS FOR USE SECTION

• shake well before use

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

• 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

Directions

DOSAGE & ADMINISTRATION SECTION

• shake well before use

• spray liberally and spread evenly by hand 15 minutes before sun exposure

• do not spray directly onto face. Spray on hands then apply to face.

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, butyloctyl salicylate, dicaprylyl carbonate, isononyl isononanoate, propanediol, isocetyl stearoyl stearate, methyl dihydroabietate, cetearyl alcohol, aloe barbadensis leaf juice, musa sapientum (banana) fruit extract, bisabolol, bentonite, cellulose gum, C18-21 alkane, caprylyl glycol, citric acid, coco-glucoside, glycerin, microcrystalline cellulose, polyhydroxystearic acid, sodium gluconate, sodium stearoyl glutamate, tocopherol, polyester-8, silica, alumina, caprylhydroxamic acid

Questions?

OTC - QUESTIONS SECTION

1-877-978-6286

Baby Bum Mineral 50 Sunscreen Primary Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary ArtworkPrimary Artwork

Baby Bum Mineral 50 Sunscreen Roll-On Primary Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary ArtworkPrimary Artwork

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-795-01Baby Bum Mineral 50 Sunscreen88 mL in 1 BOTTLE, SPRAYSPRAY881
69039-796-01Baby Bum Mineral 50 Sunscreen Roll-On88 mL in 1 TUBE, WITH APPLICATORLOTION881

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-79669039-796-01
69039-79569039-795-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 58 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
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
ndc (package): 69039-796-01
ndc (package): 69039-795-01
ndc (product): 69039-795
ndc (product): 69039-796
ndc11 (package): 69039079601
ndc11 (package): 69039079501
spl id: 3c470ff8-37d7-a729-e063-6294a90aa525
spl set id: 3c470ff8-37d6-a729-e063-6294a90aa525

Reported adverse events (FAERS/openFDA)#

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