FDA.reportPublic FDA data

BabyGanics Sunscreen

Product NDC
59062-1227
Requested package NDC
59062-1227-1
11-digit product format
590621227
Labeler code
59062
Product ID
59062-1227_eaedc1f5-5b46-4ec1-bb93-563f43f5396c
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE and ZINC OXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
KAS Direct LLC dba BabyGanics
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-06-21
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
30 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59062-122759062-1227-1DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59062-1227-12020-02-04C16284748780-19d75b9d0-9517-f424-e053-dadaa90a57cebabyganics® Sunscreen Lotion 30SPF
59062-1227-12020-01-31C16284748780-19d75b9d0-9517-f424-e053-dadaa90a57cebabyganics® Sunscreen Lotion 30SPF

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ARACHIDYL ALCOHOLINACTIVE INGREDIENT1QR1QRA9BUBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ARACHIDYL GLUCOSIDEINACTIVE INGREDIENT6JVW35JOOJBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
BUTYLOCTYL SALICYLATEINACTIVE INGREDIENT2EH13UN8D3BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CERESININACTIVE INGREDIENTQ1LS2UJO3ABABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CETEARYL OLIVATEINACTIVE INGREDIENT58B69Q84JOBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
DECYL JOJOBATEINACTIVE INGREDIENTZL61O8TFZUBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
DOCOSANOLINACTIVE INGREDIENT9G1OE216XYBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
GLYCERYL CAPRYLATEINACTIVE INGREDIENTTM2TZD4G4ABABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
JOJOBA OILINACTIVE INGREDIENT724GKU717MBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
MONOSTEARYL CITRATEINACTIVE INGREDIENTYWW937R1QRBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
POLYHYDROXYSTEARIC ACID (2300 MW)INACTIVE INGREDIENTYXH47AOU0FBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SORBITAN OLIVATEINACTIVE INGREDIENTMDL271E3GRBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SQUALANEINACTIVE INGREDIENTGW89575KF9BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
TRISODIUM ETHYLENEDIAMINE DISUCCINATEINACTIVE INGREDIENTYA22H34H9QBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
WATERINACTIVE INGREDIENT059QF0KO0RBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEBABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59062-1227-159062122701118 mL in 1 TUBE (59062-1227-1) 118 ml2013-06-210000-00-00NoNoCurrent