FDA.reportPublic FDA data

Baby Bum Mineral 50 Sunscreen Roll-On

Product NDC
69039-796
11-digit product format
690390796
Labeler code
69039
Product ID
69039-796_3c470ff8-37d7-a729-e063-6294a90aa525
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Sun Bum, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-01
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
160; 34 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Baby Bum Mineral 50 Sunscreen Roll-On
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE160 mg/mL
TITANIUM DIOXIDE34 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c470ff8-37d6-a729-e063-6294a90aa525Available on FDA.report

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
69039-796-01Baby Bum Mineral 50 Sunscreen Roll-On88 mL in 1 TUBE, WITH APPLICATORLOTION881

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 125 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJADEIA LIMITED INC35cf708c-244e-63a8-e063-6394a90a3b962025-12-15Exact identifier
application number: M020
Daily RestoreZINC OXIDETYRLIN ENTERPRISES, INC.35cead50-86a7-2cf2-e063-6294a90a5f992025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e81e8e-0ba7-93e6-e063-6294a90a4e622025-12-15Exact identifier
application number: M020
Sacred AuraZINC OXIDEIRIA SKIN OASIS LLC36eaaa54-e288-6590-e063-6394a90a403d2025-12-15Exact identifier
application number: M020
Daily Defense Facial Sunscreen Plus PrimerTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e84147-5dcd-517a-e063-6394a90a54ee2025-12-15Exact identifier
application number: M020
Sacred GlowZINC OXIDEIRIA SKIN OASIS LLC36ead65c-a46c-7395-e063-6394a90a9e042025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e91877-c4c4-7fa3-e063-6294a90a13262025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e880af-debc-657f-e063-6394a90ab6ff2025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen TintedZINC OXIDELAURA CATHERINE, LLC36e8b631-03e7-c1de-e063-6294a90aa5302025-12-15Exact identifier
application number: M020
Sheer Mineral Face And Body Sunscreen Non TintedZINC OXIDELAURA CATHERINE, LLC36e957cf-cfa5-b122-e063-6294a90a78ce2025-12-15Exact identifier
application number: M020
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9c2f3-ea89-0de3-e063-6394a90a9fb62025-12-15Exact identifier
application number: M020
Skin Shield PlusZINC OXIDELAURA CATHERINE, LLC36e9958b-cc5c-f7ff-e063-6394a90ac80d2025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d8e8ba-a3dd-257d-e063-6294a90a30d62025-12-15Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELAURA CATHERINE, LLC36e9e8d7-3fcf-1e94-e063-6394a90a8dc62025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d968df-5168-61bf-e063-6294a90a94b72025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d45b48-e08d-ef40-e063-6394a90a635c2025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN STUDIO36d439fb-b9cf-2774-e063-6294a90ae8852025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer CPlusE GlowZINC OXIDESimply Bare Waxing & Skin Care LLC36d9b48d-e3db-6ae2-e063-6294a90abbf52025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen Plus Primer MatteTITANIUM DIOXIDE, ZINC OXIDESimply Bare Waxing & Skin Care LLC36d9d83b-7da7-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Advanced Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEHELLO BEAUTIFUL SKIN & ACNE36d3ebc0-1de6-1998-e063-6294a90a02e62025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69039-796-016903907960188 mL in 1 TUBE, WITH APPLICATOR (69039-796-01) 88 ml2025-01-01NoNoCurrent