BabyGanics Sunscreen

Product NDC: 59062-1227
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59062-1227		D	Discontinued by firm		2026-10-12
excluded package	package	59062-1227	59062-1227-1	D	Discontinued by firm		2026-10-12

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59062-1227-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59062-1227-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59062-1227-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59062-1227-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59062-1227-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59062-1227-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59062-1227-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59062-1227-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59062-1227-1	`0efc9e666f02…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
59062-1227-1	2020-02-04	C162847	48780-1	9d75b9d0-9517-f424-e053-dadaa90a57ce	babyganics® Sunscreen Lotion 30SPF
59062-1227-1	2020-01-31	C162847	48780-1	9d75b9d0-9517-f424-e053-dadaa90a57ce	babyganics® Sunscreen Lotion 30SPF

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ARACHIDYL ALCOHOL	INACTIVE INGREDIENT	1QR1QRA9BU	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ARACHIDYL GLUCOSIDE	INACTIVE INGREDIENT	6JVW35JOOJ	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
BUTYLOCTYL SALICYLATE	INACTIVE INGREDIENT	2EH13UN8D3	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
COCONUT OIL	INACTIVE INGREDIENT	Q9L0O73W7L	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
DECYL JOJOBATE	INACTIVE INGREDIENT	ZL61O8TFZU	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
DOCOSANOL	INACTIVE INGREDIENT	9G1OE216XY	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
GLYCERYL CAPRYLATE	INACTIVE INGREDIENT	TM2TZD4G4A	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
MONOSTEARYL CITRATE	INACTIVE INGREDIENT	YWW937R1QR	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
POLYHYDROXYSTEARIC ACID (2300 MW)	INACTIVE INGREDIENT	YXH47AOU0F	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SHEA BUTTER	INACTIVE INGREDIENT	K49155WL9Y	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SQUALANE	INACTIVE INGREDIENT	GW89575KF9	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
SUCROSE STEARATE	INACTIVE INGREDIENT	274KW0O50M	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
TRISODIUM ETHYLENEDIAMINE DISUCCINATE	INACTIVE INGREDIENT	YA22H34H9Q	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BABYGANICS SUNSCREEN 30SPF (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [KAS DIRECT LLC DBA BABYGANICS]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59062-1227-1	59062122701	118 mL in 1 TUBE (59062-1227-1)	118 ml	2013-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
babyganics® Sunscreen Lotion 30SPF	KAS Direct LLC dba BabyGanics	2024-12-18	HUMAN OTC DRUG LABEL	5