FDA.reportPublic FDA data

Baby Skin Mineral Sunscreen

Product NDC
79265-8578
11-digit product format
792658578
Labeler code
79265
Product ID
79265-8578_ceb608aa-24c2-5138-e053-2995a90a8d42
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Sunscreen
Dosage form
LOTION
Route
TOPICAL
Labeler
Babo Botanicals, Inc.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-26
Marketing end
0000-00-00
Substance
ZINC OXIDE
Active strength
20 g/100mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct79265-8578DDiscontinued by firm2026-10-05
excluded packagepackage79265-857879265-8578-3DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

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
79265-8578-3Baby Skin Mineral Sunscreen89 mL in 1 TUBELOTION893

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79265-8578BABY SKIN MINERAL SUNSCREEN (MINERAL SUNSCREEN) LOTION [BABO BOTANICALS, INC.]3Legacy NDC, 1 package rows20241215_b0a4ac6b-8f88-8a9a-e053-2995a90ab10e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79265-8578-37926585780389 mL in 1 TUBE (79265-8578-3) 89 ml2020-08-260000-00-00NoNoCurrent